**Global Import Regulations for\
Pre-Owned (Used and Refurbished) Medical Devices**

### Prepared by

### Steven R. Harper International Trade Specialist

+--------------+-------------------------------------------------------+
| #            | ### Office of Microelectronics, Medical Equi          |
| ## ![](media | pment and Instrumentation International Trade Adminis |
| /image1.png) | tration/Trade Development U.S. Department of Commerce |
| {width="1.17 |                                                       |
| 916666666666 |                                                       |
| 67in" height |                                                       |
| ="1.18958333 |                                                       |
| 33333334in"} |                                                       |
+--------------+-------------------------------------------------------+

### Revised September 2003

Table of Contents

[Preface iv](#preface)

[Executive Summary vi](#executive-summary)

[Market Listings 1](#market-listings)

[Argentina 1](#argentina)

[Australia 19](#australia)

[Austria 21](#austria)

[Bahamas 21](#bahamas)

[Bangladesh 21](#bangladesh)

[Barbados 22](#barbados)

[Belgium 22](#belgium)

[Belize 23](#belize)

[Bolivia 24](#bolivia)

[Brazil 26](#brazil)

[Botswana 28](#botswana)

[Cameroon 29](#cameroon)

[Canada 30](#canada)

[Chad 31](#chad)

[Chile 31](#chile)

[China 32](#china)

[Colombia 34](#colombia)

[Costa Rica 34](#costa-rica)

[Croatia 35](#croatia)

[Czech Republic 35](#czech-republic)

[Denmark 36](#denmark)

[Dominican Republic 37](#dominican-republic)

[Ecuador 37](#ecuador)

[Egypt 38](#egypt)

[El Salvador 38](#el-salvador)

[Ethiopia 42](#ethiopia)

[European Union 42](#european-union)

[Finland 43](#finland)

[France 44](#france)

[Gabon 44](#gabon)

[Germany 44](#germany)

[Ghana 48](#ghana)

[Greece 49](#greece)

[Guatemala 49](#guatemala)

[Guinea 50](#guinea)

[Haiti 51](#haiti)

[Honduras 53](#honduras)

[Hong Kong 54](#hong-kong)

[Hungary 54](#hungary)

[Iceland 55](#iceland)

[India 56](#india)

[Indonesia 58](#indonesia)

[Israel 59](#israel)

[Italy 60](#italy)

[Jamaica 61](#jamaica)

[Japan 61](#japan)

[Jordan 62](#jordan)

[Kazakhstan 63](#kazakhstan)

[Kenya 63](#kenya)

[Korea, South 64](#korea-south)

[Kuwait 68](#kuwait)

[Kyrgyzstan 69](#kyrgyzstan)

[Liberia 69](#liberia)

[Luxembourg 71](#luxembourg)

[Malawi 71](#malawi)

[Malaysia 71](#malaysia)

[Mexico 72](#mexico)

[Moldova 83](#moldova)

[Morocco 84](#morocco)

[Mozambique 86](#mozambique)

[Nepal 87](#nepal)

[Netherlands 88](#netherlands)

[New Zealand 88](#new-zealand)

[Nicaragua 89](#nicaragua)

[Nigeria 89](#nigeria)

[Norway 91](#norway)

[Oman 92](#oman)

[Pakistan 92](#pakistan)

[Panama 95](#panama)

[Paraguay 98](#paraguay)

[Peru 98](#peru)

[Philippines 99](#philippines)

[Poland 101](#poland)

[Portugal 105](#portugal)

[Romania 105](#romania)

[Russia 106](#russia)

[Saudi Arabia 111](#saudi-arabia)

[Serbia and Montenegro 111](#serbia-and-montenegro)

[Senegal 111](#senegal)

[Singapore 113](#singapore)

[Slovenia 114](#slovenia)

[South Africa 114](#south-africa)

[Spain 119](#spain)

[Sri Lanka 120](#sri-lanka)

[Sweden 121](#sweden)

[Switzerland 121](#switzerland)

[Syria 122](#syria)

[Taiwan 123](#taiwan)

[Tanzania 123](#tanzania)

[Thailand 125](#thailand)

[Trinidad & Tobago 125](#trinidad-tobago)

[Tunisia 126](#tunisia)

[Turkey 126](#turkey)

[Turkmenistan 127](#turkmenistan)

[Uganda 128](#uganda)

[Ukraine 129](#ukraine)

[United Arab Emirates 131](#united-arab-emirates)

[United Kingdom 132](#united-kingdom)

[Uruguay 134](#uruguay)

[Uzbekistan 134](#uzbekistan)

[Venezuela 137](#venezuela)

[Vietnam 138](#vietnam)

[Yemen 140](#yemen)

[Zambia 141](#zambia)

[Conclusions and Next Steps 142](#conclusions-and-next-steps)

[Appendix A: Markets for Which No Information Was Available
144](#appendix-a-markets-for-which-no-information-was-available)

[Appendix B: Proposed Voluntary Self-Regulation of the Pre-Owned
Medical\
Device Industry
145](#appendix-b-proposed-voluntary-self-regulation-of-the-pre-owned-medical-device-industry)

# Preface

#### Purpose

This is the fifth edition of a report first issued in May 1999. This
report seeks to collect and compile information on the regulations
relating to the importation of pre-owned (used and refurbished) capital
medical equipment in countries around the world. It also includes some
information on market demand for such equipment.

Although this report is intended to serve as a general reference, it is
not a definitive study and data is not available or is incomplete for
many countries. This report is formally updated annually, but revisions
to the country entries are made throughout the year if new material
becomes available.

This report does not attempt to address the issue of re-use of
single-use devices (SUDs). Such re-use remains a controversial practice
and poses different safety issues than pre-owned capital equipment,
which is designed for use with multiple patients over many years.
Moreover, single-use devices are typically reprocessed by or for the
original purchaser and thus generally do not enter into international
trade.

#### Sources

The main sources for this report are responses filed by the staff of the
U.S. Commercial Service (CS) stationed in U.S. embassies and consulates
around the world to an annual request for information. This request,
made by the Office of Microelectronics, Medical Equipment, and
Instrumentation (OMMI), asks the Commercial Service trade specialists to
review the existing entry and provide answers to several questions. In
2003, the questions were as follows:

1.  Are there special restrictions or tariffs that apply to used medical
    equipment that do not apply to new medical equipment?

2.  If a manufacturer or its agent has registered a medical device in
    the country, can a third party legally import the same device in
    used/refurbished condition without the used device being subjected
    to new safety inspections, etc.?

3.  Can public health institutions buy used or refurbished medical
    devices?

4.  Is there a market for used or refurbished medical devices?

5.  If there is a market, what types of used or refurbished medical
    equipment are in the greatest demand?

The second of these questions was asked for the first time in 2003 in
order to clarify the ability of refurbishers---especially those not
affiliated with the original equipment manufacturer (OEM)---to readily
ship refurbished devices internationally.

The responses provided by the trade specialists vary from full-length
reports---typically *International Market Insight* (IMI) or *Industry
Sector Analysis* (ISA) reports---to short replies submitted by cable or
e-mail. In many cases, the specialists simply confirm the existing
entry. Entries submitted in report format are given the title and date
of the report. Other entries are simply identified by whether they were
submitted to OMMI by cable or e-mail and the date it was submitted. If
the trade specialist confirms information submitted in previous years,
both the original date of submission and the date of the confirmation
are provided.

Thirty-four CS posts responded to the cable in 2003, somewhat fewer than
in past years, perhaps reflecting the generally lack of change in import
regulations for pre-owned medical devices. The 34 responding posts
either prepared new IMI reports on pre-owned-medical equipment or sent a
cable or e-mail to OMMI addressing the above questions.

The report also includes a small number of reports on the medical-device
sector prepared by the CS trade specialists independently of OMMI's
request for information on the used-equipment sector, as well as some
cables that many CS posts submitted in 1998 in response to a request
from the Department of Commerce soliciting information on import
regulation for used and refurbished equipment generally. Entries based
on responses to this request carry a source indicating that they were
submitted by the CS post via cable and bear a date in 1998.

Although an effort has been made to preserve the text of the original
sources as much as possible, text has been reformatted and abridged in
order to present a standardized and concise format. In some cases, the
original sources have been summarized or edited.

#### Limitations of This Study

Because of the limitations of the sources, this report cannot be
considered a definitive study of import regulations relating to
pre-owned medical devices. Information, unfortunately, remains lacking
for numerous countries.

In addition, many of the cables that were in response to the 1998
request for information about import regulations for used/refurbished
equipment do not explicitly deal with medical equipment. The reporting
officer, for example, may have looked only at general import regulations
and thus not considered the possibility of more restrictive health
regulations that affect the importation of used medical devices.

Finally, medical regulations are constantly changing. What may have been
accurate when the market research was prepared may not be the case
today. In addition, custom or health officials may interpret regulations
that do not seem to present a problem in such a way as to result in
market restrictions.

#### Updates of This Report

The most recent version of this report will be posted to ITA's Medical
Equipment home page, www.ita.doc.gov/td/mdequip.

Users of this report are encouraged to inform OMMI of any information
found to be out of date or inaccurate. Contact:

Steven Harper\
Tel.: 202-482-2991\
Fax: 202-482-0975\
E-mail: Steven_Harper@ita.doc.gov

# Executive Summary

#### Findings

Information on import regulations for pre-owned medical devices was
available for 104 markets.[^1]

Of these 104 markets, 82 markets appear to permit the unrestricted
importation of used or refurbished medical equipment on the same terms
as new.[^2] Seventeen markets impose restrictions. Five generally
prohibit the importation of pre-owned devices, although one of
these---China---is in the process of liberalizing its regulations for
pre-owned medical devices.

For the purposes of this report, unrestricted importation of used or
refurbished medical equipment on the same terms as new means that *if a
device has been approved for sale in a market*,

-   That the device can be imported either as new or pre-owned
    condition;

-   That the pre-owned device is not subject to additional safety or
    registration requirements; and

-   That the pre-owned device is not subject to duties and tariffs not
    also levied on like new items.

Such unrestricted importation roughly corresponds to the unregulated
resale of medical devices in the internal U.S. market, where the U.S.
Food and Drug Administration does not regulate the resale of medical
devices.

Unrestricted importation of pre-owned devices does not mean that a
country allows the importation of devices that were never approved by
regulators. For example, to import a medical device, new or used, into
the European Union (EU), the device must bear the CE Mark, which
indicates that the device has been approved for sale in the EU. [^3]
This applies, as well, to Norway and Iceland, which are not members of
the EU, but which have adopted the EU medical-device regulatory system.
Exporters of pre-owned medical devices should thus fully investigate
whether a device has been approved for sale in the target market before
attempting to export the device in a pre-owned condition.

That a market permits the unrestricted importation of pre-owned medical
devices does not mean that it represents a good market for pre-owned
devices. Traditional buying practices favoring the latest devices,
negative impressions of pre-owned equipment, and government procurement
policies all affect the market. Of these, the last is perhaps the most
readily quantifiable. Of the 83 markets that permit the unrestricted
importation of pre-owned medical devices, 23 have laws or policies that
prevent or discourage public healthcare institutions from purchasing
pre-owned equipment. Although private healthcare facilities in these
countries can buy pre-owned equipment, the private healthcare sector
often represents a relatively small share of the market.

Markets that Permit the Importation of Pre-Owned Medical Devices\
On the Same Terms as New

  ----------------- ----------------- ----------------- -----------------
  Australia         Gabon             Malawi            Senegal

  Austria           Germany           Malaysia          Singapore

  Bahamas           Ghana             Mexico \*         Slovenia

  Barbados          Greece            Morocco           Spain

  Belgium           Guatemala         Mozambique        Sri Lanka

  Belize            Guinea            Nepal             Sweden

  Bolivia           Haiti             Netherlands       Switzerland

  Botswana          Honduras          New Zealand       Taiwan

  Cameroon          Hong Kong         Nicaragua         Tanzania

  Chad              Hungary           Nigeria           Trinidad & Tobago

  Chile             Iceland           Norway            Tunisia

  Costa Rica        Indonesia         Oman              Turkmenistan

  Czech Republic    Israel            Panama            Uganda

  Denmark           Italy             Paraguay          Ukraine

  Dominican         Jamaica           Philippines       United Arab
  Republic                                              Emirates

  Ecuador           Jordan            Poland            United Kingdom

  El Salvador       Kazakhstan        Portugal          Venezuela

  Ethiopia          Kyrgyzstan        Romania           Yemen

  European Union    Kenya             Russia            Zambia

  Finland           Liberia           Saudi Arabia      

  France            Luxembourg        Serbia and        
                                      Montenegro        
  ----------------- ----------------- ----------------- -----------------

\* Mexico permits unrestricted sales to end-users, but restricts
cross-border transactions between brokers, refurbishers, etc.

Source: U.S. Department of Commerce

Countries with Public Procurement Policies Barring or Discouraging
Purchase of Pre-Owned Equipment

  ----------------- ----------------- ----------------- -----------------
  Bahamas           Ghana             Oman              Senegal

  Cameroon          Guinea            Panama            Sri Lanka

  Chile             Honduras          Paraguay          Tanzania

  Costa Rica        Indonesia         Philippines       Uganda

  Ecuador           Mexico            Romania           United Arab
                                                        Emirates

  El Salvador       Nicaragua         Saudi Arabia      Venezuela
  ----------------- ----------------- ----------------- -----------------

Source: U.S. Department of Commerce

Seventeen countries---Argentina, Brazil, Canada, Colombia, Croatia,
India, Japan, South Korea, Moldova, Pakistan, Peru, South Africa,
Turkey, Uruguay, Uzbekistan, and Vietnam---impose restrictions of
various severity on the importation of pre-owned medical devices. These
restrictions include such regulations as the following:

-   Taxes on pre-owned device or device over a certain age

-   Ban on devices older than a certain age or beyond a set percentage
    of estimated useful life

-   Requirement that device be refurbished by original manufacturer

-   Requirement for warranties

-   Requirement that parts and service be available

-   Restrictive rights for importation (e.g., only by holder of
    registration or by end-user)

-   Requirement for new licensing or approval

-   Bureaucratic obstructionism not codified in law

In some cases, the restrictions are so severe as to be tantamount to a
prohibition. This is often so if the regulations require that the
pre-owned device be submitted to new safety licensing. Some countries do
not consider the used/refurbished device to be covered by the safety
approval granted to the like new device and require that it be submitted
for a safety review as it if were a new type of device entering the
market. It would rarely be economical for the importer to obtain a
safety review for an individual piece of refurbished equipment.[^4]

Countries that Restrict the Importation of Pre-Owned Medical Equipment

  ----------------------- ----------------------- -----------------------
  Argentina               India                   South Africa

  Bangladesh              Japan                   Turkey

  Brazil                  Korea, South            Uruguay

  Canada                  Moldova                 Uzbekistan

  Colombia                Pakistan                Vietnam

  Croatia                 Peru                    
  ----------------------- ----------------------- -----------------------

Source: U.S. Department of Commerce

Only five countries---China, Egypt, Kuwait, Syria, and Thailand---appear
to ban the importation of pre-owned medical equipment outright.

Countries that Prohibit the Importation of Pre-Owned Medical Equipment

  ----------------------------------- -----------------------------------
  China \*                            Syria

  Egypt                               Thailand

  Kuwait                              
  ----------------------------------- -----------------------------------

> \* In 2003, China was transitioning from a ban to restrictions,\
> which were still undefined in September 2003.

Source: U.S. Department of Commerce

In early 2003, however, China announced a decree that would lift the
1998 import ban on a wide range of used electro-mechanical devices,
including medical devices. Implementation of the decree, however, has
been slow, especially for medical devices, and it appears that some
restrictive conditions may remain in place. Thus, at this time, China's
import remains in a state of transition (*see the China entry for a
fuller discussion*).

Unfortunately, information about import regulations for pre-owned
medical equipment is not available for all countries and markets.
Appendix A lists 86 countries/markets for which such information was not
available.

#### Importance of the Restricted Markets for U.S. Exporters of Pre-Owned Medical Devices

Although only 22 countries are known to bar or restrict the importation
of pre-owned medical devices, these 22 countries represent key potential
markets for U.S. exporters. Not only are most of them low or
middle-income countries where buyers might be attracted to the lower
cost of pre-owned devices, the combined population of these 23 countries
(approximately 3.4 billion people) represents 58.6 percent of the total
population of potential U.S. export markets.[^5]

> Population of the 22 Countries that Restrict or Bar Importation of
> Pre-Owned Medical Devices as Percent of the Potential U.S. Export
> Market\*
>
> ![](media/image2.wmf)

\* World population minus U.S. population.

> Source: U.S. Department of Commerce

# Market Listings

## Argentina

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 17 April 2003

#### Summary

The Government of Argentina places restrictions on imports of used
capital goods, including medical equipment. This situation, however
implies a significant liberalization of imports of these products since
1994, after years of a virtually total ban on the importation of used
medical equipment.

The principal concern of Argentine authorities regarding imports of used
medical equipment is that of easing the way for well-established and
qualified suppliers to enter the market, while protecting the industry
from unreliable suppliers which have at different times sold badly
refurbished machines or equipment without appropriate after-sale
support.

Restrictions and bans on the imports of used medical equipment are
established by Resolution MEOSP 909/94, issued by the Ministry of
Economy in 1994 (and Resolution MEOSP 1472/94) and amended by Annex II
and III of the Resolution MEOSP 748/95, (and by Resolution MEOSP 235/99)
determining a classification of imports as follows:

1.  Used products that can be imported if the conditions stated below
    for the manufacturer, purchaser and sales representative are met
    (equipment certified by manufacturer, availability of after-sales
    servicing and availability of spare parts, purchaser must prove it
    is unable to purchase new equipment, etc.).

```{=html}
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```
6.  Used products that cannot be imported

7.  Used and refurbished products that may be freely imported.

#### Annex II of Resolution MEOSP 748/95: Used Medical Equipment that Can be Imported under Certain Conditions

\[This Resolution replaced Annex I of Resolution 909/94.\]

For items listed in the table below, refurbished goods must be
accompanied by a certificate issued by the original manufacturer, or by
a technical assessment certificate authenticated by the Commercial
Section of the Argentine Embassy or the Argentine Consulate in the
export country, as proof of refurbishment. Refurbishment can be done in
Argentina by the importer, provided he is the end-user, and these goods
cannot be resold. In this case, the goods must remain in his or her
possession for a period of two years, during which time donation or sale
of the goods is prohibited. The end-user is subject to a proof of
destination fee of 2 percent on the CIF value.

For importing refurbished goods, the foreign vendor must ensure the
buyer of the availability of after-sales service and spare parts, and
have an exclusive sales agent based in Argentina who will be able to
implement the servicing required during the period of guarantee.

In the case of direct imports by the end-user, an official
representative in-country is not required; provision of spare parts and
servicing are at the importer's risk.

Re-importing of used goods, which had been previously exported
temporarily in order to be repaired or to undergo any other improvement,
are exempted from the refurbishment certification requirements.

HS Codes of Items subject to Annex II of Res. MEOSP 748/95

  --------------- --------------- ------------ --------------- ------------
  9018.49.30      9018.49.40      9022.13.11   9022.13.90      9022.14.90

  9024.10.10      9024.10.20      9024.10.90   9025.19.10      9025.19.90

  9025.80.00      9026.10.11      9026.10.19   9026.10.20      9026.20.10

  9026.20.90      9026.80.00      9027.10.00   9027.20.20      9027.30.11

  9027.30.19      9027.30.21      9027.30.22   9027.30.23      9027.30.29

  9027.30.31      9027.30.39      9027.50.10   9027.50.20      9027.50.30

  9027.50.40      9027.50.90      9027.80.11   9027.80.12      9027.80.13

  9027.80.14      9027.80.20      9027.80.30   9027.80.90      9028.10.10

  9028.10.90      9028.20.10      9028.20.20   9028.30.11      9028.30.19

  9028.30.21      9028.30.29      9028.30.31   9028.30.39      9028.30.90

  9030.20.10      9030.20.21      9030.20.22   9030.20.29      9030.20.30

  9030.39.90      9030.40.20      9030.82.10   9030.82.90      9030.83.10

  9030.83.20      9030.83.30      9030.83.90   9031.10.00      9031.20.10

  9031.20.90      9031.30.00      9031.80.11   9031.80.12      9031.80.20

  9031.80.30      9031.80.40      9031.80.50   9031.80.60      9031.80.90

  9032.89.30                                                   
  --------------- --------------- ------------ --------------- ------------

#### Annex III of Res 748/95: Goods that are temporarily banned from importation.

\[Replaces Annex II of Res. 909/94\]

Below is a list of HS codes, for which the importation of used equipment
is temporarily banned. However, parts and components of goods classified
under Chapter 84-90 of NCM (Mercosur Common Nomenclature) are exempted
from this ban (i.e. they can be legally imported), if they have been
refurbished by the original manufacturer and carry a guarantee
certificate. Such items can be imported for use paying a 28 percent
import tariff, plus 0.5 percent statistics fee and 2 percent of proof of
destination fee.

Additional exemptions from this ban are:

-   Goods imported for Turnkey Projects

-   Goods destined to scientific and technological research, under the
    system established by Decree 732/72; and

-   Used goods that had been temporarily exported in order to be
    repaired or to undergo any other improvement.

Annex III of Resolution MEOSP 748/95: Prohibited Items

  -------------- -------------- -------------- -------------- --------------
  9018.11.00     9018.12.90     9018.14.00     9018.19.20     9018.19.80

  9018.19.90     9018.20.00     9018.31.11     9018.31.19     9018.31.90

  9018.32.11     9018.32.12     9018.32.19     9018.32.20     9018.39.10

  9018.39.21     9018.39.22     9018.39.23     9018.39.29     9018.39.30

  9018.39.90     9018.41.00     9018.49.11     9018.49.12     9018.49.19

  9018.49.20     9018.49.99     9018.50.00     9018.90.10     9018.90.21

  9018.90.29     9018.90.39     9018.90.40     9018.90.50     9018.90.91

  9018.90.92     9018.90.95     9018.90.99     9019.10.00     9019.20.10

  9019.20.20     9019.20.30     9019.20.40     9019.20.90     9020.00.10

  9020.00.90     9021.11.10     9021.11.20     9021.11.90     9021.19.10

  9021.19.20     9021.19.91     9021.19.99     9021.21.10     9021.21.90

  9021.29.00     9021.30.11     9021.30.19     9021.30.20     9021.30.30

  9021.30.40     9021.30.80     9021.30.91     9021.30.99     9021.40.00

  9021.50.00     9021.90.11     9021.90.19     9021.90.80     9021.90.91

  9021.90.92     9021.90.99     9022.13.19     9022.14.11     9022.14.12

  9022.14.13     9022.14.19     9022.19.90     9022.21.10     9022.21.20

  9022.21.90     9022.29.00     9022.30.00     9022.90.11     9022.90.12

  9022.90.19     9022.90.80     9022.90.90     9023.00.00     9024.90.00

  9025.11.10     9025.11.90     9025.90.10     9025.90.90     9026.90.10

  9026.90.20     9026.90.90     9027.90.10     9027.90.91     9027.90.92

  9027.90.93     9027.90.99     9028.90.10     9028.90.90     9029.10.10

  9029.10.90     9029.20.10     9029.20.20     9029.90.10     9029.90.90

  9030.10.10     9030.10.90     9030.39.21     9030.90.10     9030.90.20

  9030.90.30     9030.90.90     9031.90.10     9031.90.90     9032.10.10

  9032.10.90     9032.20.00     9032.81.00     9032.89.11     9032.89.19

  9032.89.21     9032.89.22     9032.89.23     9032.89.24     9032.89.25

  9032.89.29     9032.89.81     9032.89.82     9032.89.83     9032.89.84

  9032.89.89     9032.89.90     9032.90.10     9032.90.91     9032.90.99

  9033.00.00                                                  
  -------------- -------------- -------------- -------------- --------------

#### Used Goods Not Included in Either List

Used goods not included in either list may be imported into Argentina.
Equipment such as ultrasonic scanners and magnetic resonance imaging
apparatus, among others, are not on either of the above lists and used
equipment of these types may be imported.

#### General Import Regulations for Used Medical Equipment

Most used goods are subject to an average import fee of about 28 percent
(varying according to product) plus the Statistics Fee of 0.5 percent.
Some others will pay around 16.5 percent or 12.5 percent, plus
Statistics Fee. (Resolution ME 8/01, Annex I)

Used goods must fulfill all health control, safety, environmental, and
consumer rights regulations governing importation of those same new
goods*.*

There are no exemptions to the aforementioned Resolutions, regarding
public health institutions purchasing practices, unless the equipment
(which must be no lesser than five years old) is donated to
(institutions depending on) the national, provincial or municipal
government, and to religious or welfare organizations accredited as
such. (Resolution MP 37/2003)

Used equipment may represent an attractive alternative for the tighter
budgets of hospital and clinics as soon as the current Argentine
economic and financial crisis recedes and the situation is normalized
allowing for defining procurement needs.

There is currently a federal sanitary emergency due mainly to a lack of
imported medical and pharmaceutical supplies. This lack of critical
supplies has been partly caused by the reported difficulties of
importers to re-stock supplies given the uncertain value of the peso as
a result of the new floating exchange rate and temporary payment
restrictions on imports that the Argentine federal government imposed in
mid-December 2001. Fortunately, most medical supplies and equipment are
allowed to be paid in advance under these new rules.

Due to these reasons, government authorities and the private sector are
mainly concentrating their purchases on critical supplies, rather than
investing on updating technology. However, the United States has always
had an excellent reputation in Argentina for producing top
high-technology medical equipment and for refurbishing used equipment
with an outstanding level of quality. U.S. firms that may find
opportunities in this market, may need to take additional caution,
especially in ensuring payment through cash in advance or letter of
credit (for products that cannot be paid for in advance).

#### Mercosur HS Codes and U.S. Schedule B HS Codes

Below is a list of Mercosur HS Codes and a list of US Schedule B HS
Codes, with product description (applicable to medical equipment) to
assist you in classifying your product.

List of Mercosur HS Codes

+---------------+------------------------------------------------------+
| HS Code       | Description                                          |
+===============+======================================================+
| 9018          | Instrumentos y aparatos de medicina, cirugia,        |
|               | odontologia o veterinaria, incluidos los de          |
|               | centellografia y demas aparatos electromedicos, asi  |
|               | como los aparatos para pruebas visuales              |
|               |                                                      |
|               | \[Instruments and appliances used in medical/        |
|               | surgical/ dental or veterinary sciences, including   |
|               | electro-medical and sight-testing)/ parts etc.       |
|               | thereof\]                                            |
+---------------+------------------------------------------------------+
| 90181         | Aparatos de electrodiagnóstico (incluidos los        |
|               | aparatos de exploración funcional o de vigilancia de |
|               | parámetros fisiológicos:                             |
+---------------+------------------------------------------------------+
| 90181100      | Electrocardiógrafos                                  |
+---------------+------------------------------------------------------+
| 90181200      | Aparatos de diagnóstico por exploración ultrasónica  |
+---------------+------------------------------------------------------+
| 90181210      | Ecógrafos con análisis espectral Doppler             |
+---------------+------------------------------------------------------+
| 90181290      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90181300      | Aparatos de diagnóstico de visualización por         |
|               | resonancia magnética                                 |
+---------------+------------------------------------------------------+
| 90181400      | Aparatos de centellografía                           |
+---------------+------------------------------------------------------+
| 90181910      | Endoscopios                                          |
+---------------+------------------------------------------------------+
| 90181920      | Audiómetros                                          |
+---------------+------------------------------------------------------+
| 90181930      | Cámaras Gamma                                        |
+---------------+------------------------------------------------------+
| 90181980      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90181990      | Partes                                               |
+---------------+------------------------------------------------------+
| 901820        |                                                      |
+---------------+------------------------------------------------------+
| 90182010      | Para cirugía de córnea, que operen por láser         |
+---------------+------------------------------------------------------+
| 90182090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90183         | Jeringas, agujas,catéteres,cánulas e instrumentos    |
|               | similares:                                           |
+---------------+------------------------------------------------------+
| 901831        | Jeringas, incluso con agujas                         |
+---------------+------------------------------------------------------+
| 9018311       | De material plástico                                 |
+---------------+------------------------------------------------------+
| 90183111      | De capacidad inferior o igual a 2 cm3                |
+---------------+------------------------------------------------------+
| 901832        | Agujas tubulares de metal y agujas de sutura         |
+---------------+------------------------------------------------------+
| 90183220      | De sutura                                            |
+---------------+------------------------------------------------------+
| 90183910      | Agujas                                               |
+---------------+------------------------------------------------------+
| 9018392       | Sondas, catéteres y cánulas                          |
+---------------+------------------------------------------------------+
| 90183921      | De caucho                                            |
+---------------+------------------------------------------------------+
| 90183922      | Catéter de policloruro de vinilo, para embolectomía  |
|               | arterial                                             |
+---------------+------------------------------------------------------+
| 90183923      | Catéter de policloruro de vinilo, para termodilución |
+---------------+------------------------------------------------------+
| 90183929      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90183930      | Lancetas para vacunación y cauterios                 |
+---------------+------------------------------------------------------+
| 90183990      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90184         | Los demás instrumentos y aparatos de odontología:    |
+---------------+------------------------------------------------------+
| 90184100      | Tornos dentales, incluso combinados con otros        |
|               | equipos dentales sobre basamento común               |
+---------------+------------------------------------------------------+
| 901849        | Los demás                                            |
+---------------+------------------------------------------------------+
| 9018491       | Fresas                                               |
+---------------+------------------------------------------------------+
| 90184911      | De carburo de tungsteno                              |
+---------------+------------------------------------------------------+
| 90184912      | De acero al vanadio                                  |
+---------------+------------------------------------------------------+
| 90184919      | Las demás                                            |
+---------------+------------------------------------------------------+
| 90184920      | Limas                                                |
+---------------+------------------------------------------------------+
| 90184930      | Limas, Que operen por láser, para tratamiento bucal  |
+---------------+------------------------------------------------------+
| 90184940      | Que operen por proyección cinética de partículas,    |
|               | para tratamiento bucal                               |
+---------------+------------------------------------------------------+
| 9018499       | Los demás                                            |
+---------------+------------------------------------------------------+
| 90184991      | Para el diseño y la construcción de piezas cerámicas |
|               | para restauración dental, computarizados             |
+---------------+------------------------------------------------------+
| 90184999      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90185000      | Los demás instrumentos y aparatos de oftalmología    |
+---------------+------------------------------------------------------+
| 901890        | Los demás instrumentos y aparatos                    |
+---------------+------------------------------------------------------+
| 90189010      | Para transfusión de sangre o infusión intravenosa    |
+---------------+------------------------------------------------------+
| 9018902       | Bisturíes                                            |
+---------------+------------------------------------------------------+
| 90189021      | Eléctricos                                           |
+---------------+------------------------------------------------------+
| 90189029      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9018903       | Litotomos y litotritores                             |
+---------------+------------------------------------------------------+
| 90189031      | Litotritores por onda de choque                      |
+---------------+------------------------------------------------------+
| 90189039      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90189040      | Riñones artificiales                                 |
+---------------+------------------------------------------------------+
| 90189050      | Aparatos de diatermia                                |
+---------------+------------------------------------------------------+
| 9018909       | Los demás                                            |
+---------------+------------------------------------------------------+
| 90189091      | Incubadoras para bebés                               |
+---------------+------------------------------------------------------+
| 90189092      | Aparatos para medida de la presión arterial          |
+---------------+------------------------------------------------------+
| 90189093      | Equipos para terapia intrauretral por microondas     |
|               | apto para el tratamiento de afecciones prostáticas,  |
|               | computarizados                                       |
+---------------+------------------------------------------------------+
| 90189094      | Endoscopios                                          |
+---------------+------------------------------------------------------+
| 90189095      | Grampas y clipes, sus aplicadores y extractores      |
+---------------+------------------------------------------------------+
| 90189099      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9019          | Aparatos de mecanoterapia; aparatos para masajes;    |
|               | aparatos de sicotecnia; aparatos de ozonoterapia,    |
|               | oxigenoterapia o aerosolterapia, aparatos            |
|               | respiratorios de reanimacion y demas aparatos de     |
|               | terapia respiratoria                                 |
|               |                                                      |
|               | \[mechano-therapy/ massage/ psychological            |
|               | aptitude-testing appliances and apparatus/ ozone     |
|               | etc. therapy and respiration apparatus/ parts and    |
|               | accessories\]                                        |
+---------------+------------------------------------------------------+
| 90191000      | Aparatos de mecanoterapia; aparatos para masajes;    |
|               | aparatos de sicotecnia                               |
+---------------+------------------------------------------------------+
| 901920        | Aparatos de ozonoterapia, oxigenoterapia o           |
|               | aerosolterapia, aparatos respiratorios de            |
|               | reanimación y demás aparatos de terapia respiratoria |
+---------------+------------------------------------------------------+
| 90192010      | De oxigenoterapia                                    |
+---------------+------------------------------------------------------+
| 90192020      | De aerosolterapia                                    |
+---------------+------------------------------------------------------+
| 90192030      | Respiratorios de reanimación                         |
+---------------+------------------------------------------------------+
| 90192090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9021          | Articulos y aparatos de ortopedia, incluidas las     |
|               | fajas y vendajes medicoquirurgicos y las muletas;    |
|               | tablillas, ferulas u otros articulos y aparatos para |
|               | fracturas; articulos y aparatos de protesis;         |
|               | audifonos y demas aparatos que lleve la propia       |
|               | persona o se le implanten para compensar un defecto  |
|               | o incapacidad                                        |
|               |                                                      |
|               | \[orthopedic appliances/splints, etc./artificial     |
|               | parts of the body/hearing aids and other appliances  |
|               | to compensate for a defect, etc./parts etc.\]        |
+---------------+------------------------------------------------------+
| 90211         | Prótesis articulares y demás artículos y aparatos de |
|               | ortopedia o para fracturas:                          |
+---------------+------------------------------------------------------+
| 902111        | Prótesis articulares                                 |
+---------------+------------------------------------------------------+
| 90211110      | Femorales                                            |
+---------------+------------------------------------------------------+
| 90211120      | Mioeléctricas                                        |
+---------------+------------------------------------------------------+
| 902119        | Los demás                                            |
+---------------+------------------------------------------------------+
| 90211910      | Artículos y aparatos de ortopedia                    |
+---------------+------------------------------------------------------+
| 90211920      | Artículos y aparatos para fracturas                  |
+---------------+------------------------------------------------------+
| 9021199       | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90211991      | De artículos y aparatos de ortopedia, articulados    |
+---------------+------------------------------------------------------+
| 90211999      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90212         | Artículos y aparatos de prótesis dental:             |
+---------------+------------------------------------------------------+
| 902121        | Dientes artificiales.                                |
+---------------+------------------------------------------------------+
| 90212110      | De acrílico                                          |
+---------------+------------------------------------------------------+
| 90212190      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90212900      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902130        | Los demás artículos y aparatos de prótesis           |
+---------------+------------------------------------------------------+
| 9021301       | Válvulas cardíacas                                   |
+---------------+------------------------------------------------------+
| 90213011      | Mecánicas                                            |
+---------------+------------------------------------------------------+
| 90213019      | Las demás                                            |
+---------------+------------------------------------------------------+
| 90213020      | Lentillas intraoculares                              |
+---------------+------------------------------------------------------+
| 90213030      | Prótesis de arterias vasculares revestidas           |
+---------------+------------------------------------------------------+
| 90213040      | Prótesis mamáreas no implantables                    |
+---------------+------------------------------------------------------+
| 90213080      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9021309       | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90213091      | Partes de prótesis modulares que reemplazan miembros |
+---------------+------------------------------------------------------+
| 90213091      | Superiors o inferiores                               |
+---------------+------------------------------------------------------+
| 90213099      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90214000      | Audífonos, excepto sus partes y accesorios           |
+---------------+------------------------------------------------------+
| 90215000      | Estimuladores cardíacos, excepto sus partes y        |
|               | accesorios                                           |
+---------------+------------------------------------------------------+
| 902190        | Los demás                                            |
+---------------+------------------------------------------------------+
| 9021901       | Aparatos que se implantan en el organismo para       |
|               | compensar un defecto o una incapacidad               |
+---------------+------------------------------------------------------+
| 90219011      | Cardiodesfibrilador automático                       |
+---------------+------------------------------------------------------+
| 90219019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90219080      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9021909       | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90219091      | De estimuladores cardíacos (marcapasos)              |
+---------------+------------------------------------------------------+
| 90219092      | De audífonos                                         |
+---------------+------------------------------------------------------+
| 90219099      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9022          | Aparatos de rayos x y aparatos que utilicen          |
|               | radiaciones alfa, beta o gamma, incluso para uso     |
|               | medico, quirurgico, odontologico o veterinario,      |
|               | incluidos los aparatos de radiografia o              |
|               | radioterapia, tubos de rayos x y demas dispositivos  |
|               | generadores de rayos x, generadores de tension,      |
|               | consolas de mando, pantallas, mesas, sillones y      |
|               | soportes similares para examen o tratamiento         |
|               |                                                      |
|               | \[X-ray, etc. apparatus/including radiography or     |
|               | radiotherapy apparatus/X-ray tubes and generators/   |
|               | high tension generators, etc./parts and              |
|               | accessories\]                                        |
+---------------+------------------------------------------------------+
| 90221         | Aparatos de rayos X, incluso para uso médico,        |
|               | quirúrgico, odontológico o veterinario, incluidos    |
|               | los aparatos de radiografía o radioterapia:          |
+---------------+------------------------------------------------------+
| 90221200      | Aparatos de tomografía computarizados                |
+---------------+------------------------------------------------------+
| 902213        | Los demás, para uso odontológico                     |
+---------------+------------------------------------------------------+
| 9022131       | De diagnóstico                                       |
+---------------+------------------------------------------------------+
| 90221311      | De tomas maxilares panorámicas                       |
+---------------+------------------------------------------------------+
| 90221319      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90221390      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902214        | Los demás, para uso médico, quirúrgico o veterinario |
+---------------+------------------------------------------------------+
| 9022141       | De diagnóstico                                       |
+---------------+------------------------------------------------------+
| 90221411      | Para mamografía                                      |
+---------------+------------------------------------------------------+
| 90221412      | Para angiografía                                     |
+---------------+------------------------------------------------------+
| 90221413      | Para densitometría ósea, computarizado               |
+---------------+------------------------------------------------------+
| 90221419      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90221490      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902219        | Para otros usos                                      |
+---------------+------------------------------------------------------+
| 90221910      | Espectrómetros o espectrógrafos de rayos X           |
+---------------+------------------------------------------------------+
| 90221990      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90222         | Aparatos que utilicen radiaciones alfa, beta o       |
|               | gamma, incluso para uso médico, quirúrgico,          |
|               | odontológico o veterinario, incluidos los aparatos   |
|               | de radiografía o radioterapia:                       |
+---------------+------------------------------------------------------+
| 902221        | Para uso médico, quirúrgico, odontológico o          |
|               | veterinario                                          |
+---------------+------------------------------------------------------+
| 90222110      | Aparatos de radiocobalto (bomba de cobalto)          |
+---------------+------------------------------------------------------+
| 90222120      | Aparatos de gammaterapia                             |
+---------------+------------------------------------------------------+
| 90222190      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90222900      | Para otros usos                                      |
+---------------+------------------------------------------------------+
| 90223000      | Tubos de rayos X                                     |
+---------------+------------------------------------------------------+
| 902290        | Los demás, incluidas las partes y accesorios         |
+---------------+------------------------------------------------------+
| 9022901       | Aparatos                                             |
+---------------+------------------------------------------------------+
| 90229011      | Generadores de tensión                               |
+---------------+------------------------------------------------------+
| 90229012      | Pantallas radiológicas                               |
+---------------+------------------------------------------------------+
| 90229019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90229080      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90229090      | Partes y accesorios de aparatos de rayos X           |
+---------------+------------------------------------------------------+
| 90230000      | Instrumentos, aparatos y modelos concebidos para     |
|               | demostraciones (por ejemplo: en la enseñanza o       |
|               | exposiciones), no susceptibles de otros usos         |
|               |                                                      |
|               | \[instruments/ apparatus and models/ designed for    |
|               | demonstrational purposes/ unsuitable for other       |
|               | uses\]                                               |
+---------------+------------------------------------------------------+
| 9024          | Maquinas y aparatos para ensayos de                  |
|               | dureza,traccion,compresion, elasticidad u otras      |
|               | propiedades mecanicas de materiales (por ejemplo:    |
|               | metal, madera, textil, papel, plastico). \[machines  |
|               | and appliances for testing the mechanical properties |
|               | of materials (hardness/ strength etc. of metal/      |
|               | wood/ paper etc.)/ parts and accessories\]           |
+---------------+------------------------------------------------------+
| 902410        | Máquinas y aparatos para ensayo de metales           |
+---------------+------------------------------------------------------+
| 90241010      | Para ensayos de tracción o de compresión             |
+---------------+------------------------------------------------------+
| 90241020      | Para ensayos de dureza                               |
+---------------+------------------------------------------------------+
| 90241090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902480        | Las demás máquinas y aparatos                        |
+---------------+------------------------------------------------------+
| 9024801       | Máquinas y aparatos para ensayos de textiles         |
+---------------+------------------------------------------------------+
| 90248011      | Automáticos, para hilados                            |
+---------------+------------------------------------------------------+
| 90248019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90248020      | Máquinas y aparatos para ensayos de papel, cartón,   |
|               | linóleo y plástico o caucho flexibles                |
+---------------+------------------------------------------------------+
| 90248090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90249000      | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 9025          | Densimetros, areometros, pesaliquidos e instrumentos |
|               | flotantes similares, termometros, pirometros,        |
|               | barometros, higrometros y sicrometros, aunque sean   |
|               | registradores, incluso combinados entre si           |
|               |                                                      |
|               | \[hydrometers/ thermometers/ pyrometers/ barometers/ |
|               | hygrometers and psychrometers etc./ parts and        |
|               | accessories thereof\]                                |
+---------------+------------------------------------------------------+
| 90251         | Termómetros y pirómetros,sin combinar con otros      |
|               | instrumentos:                                        |
+---------------+------------------------------------------------------+
| 902511        | De líquido, con lectura directa                      |
+---------------+------------------------------------------------------+
| 90251110      | Termómetros clínicos                                 |
+---------------+------------------------------------------------------+
| 90251190      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902519        | Los demás                                            |
+---------------+------------------------------------------------------+
| 90251910      | Pirómetros ópticos                                   |
+---------------+------------------------------------------------------+
| 90251990      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90258000      | Los demás instrumentos                               |
+---------------+------------------------------------------------------+
| 902590        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90259010      | De termómetros                                       |
+---------------+------------------------------------------------------+
| 90259090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9026          | Instrumentos y aparatos para la medida o control del |
|               | caudal, nivel, presion u otras caracteristicas       |
|               | variables de liquidos o gases (por ejemplo:          |
|               | caudalimetros, indicadores de nivel, manometros,     |
|               | contadores de calor), excepto los instrumentos y     |
|               | aparatos de las partidas nos 90.14, 90.15, 90.28 o   |
|               | 90.32.                                               |
|               |                                                      |
|               | \[instruments and apparatus for measuring or         |
|               | checking the flow/ level/ pressure or other          |
|               | variables of liquids or gases/ nesoi/ parts and      |
|               | accessories\]                                        |
+---------------+------------------------------------------------------+
| 902610        | Para medida o control del caudal o nivel de líquidos |
+---------------+------------------------------------------------------+
| 9026101       | Para medida o control de caudal                      |
+---------------+------------------------------------------------------+
| 90261011      | Medidores - transmisores electrónicos, que funcionen |
|               | por el principio de inducción electromagnética       |
+---------------+------------------------------------------------------+
| 90261019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90261020      | Para medida o control de nivel                       |
+---------------+------------------------------------------------------+
| 902620        | Para medida o control de presión                     |
+---------------+------------------------------------------------------+
| 90262010      | Manómetros                                           |
+---------------+------------------------------------------------------+
| 90262090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90268000      | Los demás instrumentos y aparatos                    |
+---------------+------------------------------------------------------+
| 902690        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90269010      | De instrumentos y aparatos para medida o control de  |
|               | nivel                                                |
+---------------+------------------------------------------------------+
| 90269020      | De manómetros                                        |
+---------------+------------------------------------------------------+
| 90269090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9027          | Instrumentos y aparatos para analisis fisicos o      |
|               | quimicos (por ejemplo: polarimetros, refractometros, |
|               | espectrometros, "analizadores de gases o humos);     |
|               | instrumentos y aparatos para" ensayos de viscosidad, |
|               | porosidad, dilatacion, tension superfi- cial o       |
|               | similares o para medidas calorimetricas, acusticas o |
|               | "fotometricas                                        |
|               |                                                      |
|               | \[incluidos los exposimetros); microtomos.           |
|               | (instruments and apparatus for physical or chemical  |
|               | analysis/ including checking viscosity/ expansion/   |
|               | heat/ sound/ light etc./ microtomes/ parts etc.\]    |
+---------------+------------------------------------------------------+
| 90271000      | Analizadores de gases o humos                        |
+---------------+------------------------------------------------------+
| 902720        | Cromatógrafos e instrumentos de electroforesis       |
+---------------+------------------------------------------------------+
| 9027201       | Cromatógrafos                                        |
+---------------+------------------------------------------------------+
| 90272011      | De fase gaseosa                                      |
+---------------+------------------------------------------------------+
| 90272012      | De fase líquida                                      |
+---------------+------------------------------------------------------+
| 90272019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90272020      | Instrumentos de electroforesis                       |
+---------------+------------------------------------------------------+
| 902730        | Espectrómetros, espectrofotómetros y espectrógrafos  |
|               | que utilicen radiaciones ópticas (UV, visibles, IR)  |
+---------------+------------------------------------------------------+
| 9027301       | Espectrómetros                                       |
+---------------+------------------------------------------------------+
| 90273011      | De emisión óptica (emisión atómica)                  |
+---------------+------------------------------------------------------+
| 90273019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9027302       | Espectrofotómetros                                   |
+---------------+------------------------------------------------------+
| 90273021      | De radiaciones UV, visibles o IR                     |
+---------------+------------------------------------------------------+
| 90273022      | De absorción atómica                                 |
+---------------+------------------------------------------------------+
| 90273023      | De emisión óptica (emisión atómica)                  |
+---------------+------------------------------------------------------+
| 90273029      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9027303       | Espectrógrafos                                       |
+---------------+------------------------------------------------------+
| 90273031      | De emisión óptica (emisión atómica)                  |
+---------------+------------------------------------------------------+
| 90273039      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90274000      | Exposímetros                                         |
+---------------+------------------------------------------------------+
| 902750        | Los demás instrumentos y aparatos que utilicen       |
|               | radiaciones ópticas (UV, visibles, IR)               |
+---------------+------------------------------------------------------+
| 90275010      | Colorímetros                                         |
+---------------+------------------------------------------------------+
| 90275020      | Fotómetros                                           |
+---------------+------------------------------------------------------+
| 90275030      | Refractómetros                                       |
+---------------+------------------------------------------------------+
| 90275040      | Sacarímetros                                         |
+---------------+------------------------------------------------------+
| 90275090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902780        | Los demás instrumentos y aparatos                    |
+---------------+------------------------------------------------------+
| 9027801       | Calorímetros, viscosímetros, densitómetros y         |
|               | pehachímetros                                        |
+---------------+------------------------------------------------------+
| 90278011      | Calorímetros                                         |
+---------------+------------------------------------------------------+
| 90278012      | Viscosímetros                                        |
+---------------+------------------------------------------------------+
| 90278013      | Densitómetros                                        |
+---------------+------------------------------------------------------+
| 90278014      | Pehachímetros                                        |
+---------------+------------------------------------------------------+
| 90278020      | Espectrómetros de masa                               |
+---------------+------------------------------------------------------+
| 90278030      | Polarógrafos                                         |
+---------------+------------------------------------------------------+
| 90278090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902790        | Micrótomos; partes y accesorios                      |
+---------------+------------------------------------------------------+
| 90279010      | Micrótomos                                           |
+---------------+------------------------------------------------------+
| 9027909       | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90279091      | De espectrómetros de emisión óptica (emisión         |
|               | atómica)                                             |
+---------------+------------------------------------------------------+
| 90279092      | De espectrógrafos de emisión óptica (emisión         |
|               | atómica)                                             |
+---------------+------------------------------------------------------+
| 90279093      | De polarógrafos                                      |
+---------------+------------------------------------------------------+
| 90279099      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9028          | Contadores de gas, liquido o electricidad, incluidos |
|               | los de calibracion                                   |
|               |                                                      |
|               | \[gas/ liquid or electricity supply or production    |
|               | meters/ including calibrating meters therefor/ parts |
|               | and accessories thereof\]                            |
+---------------+------------------------------------------------------+
| 902810        | Contadores de gas                                    |
+---------------+------------------------------------------------------+
| 90281010      | De gas natural comprimido, electrónicos              |
+---------------+------------------------------------------------------+
| 90281090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902820        | Contadores de líquido                                |
+---------------+------------------------------------------------------+
| 90282010      | De peso inferior o igual a 50 kg                     |
+---------------+------------------------------------------------------+
| 90282020      | De peso superior a 50 kg                             |
+---------------+------------------------------------------------------+
| 902830        | Contadores de electricidad                           |
+---------------+------------------------------------------------------+
| 9028301       | Monofásicos para corriente alterna                   |
+---------------+------------------------------------------------------+
| 90283011      | Numéricos (digitales)                                |
+---------------+------------------------------------------------------+
| 90283019      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9028302       | Bifásicos                                            |
+---------------+------------------------------------------------------+
| 90283021      | Numéricos (digitales)                                |
+---------------+------------------------------------------------------+
| 90283029      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9028303       | Trifásicos                                           |
+---------------+------------------------------------------------------+
| 90283031      | Numéricos (digitales)                                |
+---------------+------------------------------------------------------+
| 90283039      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90283090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902890        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90289010      | De contadores de electricidad                        |
+---------------+------------------------------------------------------+
| 90289090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9029          | Los demas contadores (por                            |
|               | ejemplo:cuentarrevoluciones,contado- res de          |
|               | produccion, taximetros, cuentakilometros,            |
|               | podometros); velocimetros y tacometros, excepto los  |
|               | de las partidas nos "90.14 o 90.15; estroboscopios.  |
|               |                                                      |
|               | \[revolution and production counters/ taximeters     |
|               | etc./ speedometers and tachometers nesoi/            |
|               | stroboscopes/ parts and accessories thereof\]        |
+---------------+------------------------------------------------------+
| 902910        | Cuentarrevoluciones, contadores de producción,       |
|               | taxímetros, cuentakilómetros, podómetros y           |
|               | contadores similares                                 |
+---------------+------------------------------------------------------+
| 90291010      | Cuentarrevoluciones, contadores de producción o de   |
|               | horas de trabajo                                     |
+---------------+------------------------------------------------------+
| 90291090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 902920        | Velocímetros y tacómetros; estroboscopios"           |
+---------------+------------------------------------------------------+
| 90292010      | Velocímetros y tacómetros                            |
+---------------+------------------------------------------------------+
| 90292020      | Estroboscopios                                       |
+---------------+------------------------------------------------------+
| 902990        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90299010      | De velocímetros y tacómetros                         |
+---------------+------------------------------------------------------+
| 90299090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9030          | Osciloscopios, analizadores de espectro y demas      |
|               | instrumentos y aparatos para medida o control de     |
|               | magnitudes electricas; instrumentos y aparatos para  |
|               | medida o deteccion de radiaciones alfa, beta, gamma, |
|               | x, cosmicas o demas radiaciones ionizantes           |
|               |                                                      |
|               | \[oscilloscopes/ spectrum analyzers etc. for         |
|               | measuring etc. electrical quantities/ nesoi/ devices |
|               | for measuring etc. ionizing radiations/ parts etc.\] |
+---------------+------------------------------------------------------+
| 903010        | Instrumentos y aparatos para medida o detección de   |
|               | radiaciones ionizantes                               |
+---------------+------------------------------------------------------+
| 90301010      | Medidores de radiactividad                           |
+---------------+------------------------------------------------------+
| 90301090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903020        | Osciloscopios y oscilógrafos catódicos               |
+---------------+------------------------------------------------------+
| 90302010      | Osciloscopios numéricos (digitales)                  |
+---------------+------------------------------------------------------+
| 9030202       | Osciloscopios analógicos                             |
+---------------+------------------------------------------------------+
| 90302021      | De frecuencia superior o igual a 60 MHz              |
+---------------+------------------------------------------------------+
| 90302022      | Vectorscopio                                         |
+---------------+------------------------------------------------------+
| 90302029      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90302030      | Oscilógrafos                                         |
+---------------+------------------------------------------------------+
| 90303         | Los demás instrumentos y aparatos para medida o      |
|               | control de tensión, intensidad, resistencia o        |
|               | potencia, sin dispositivo registrador:               |
+---------------+------------------------------------------------------+
| 90303100      | Multímetros                                          |
+---------------+------------------------------------------------------+
| 903039        | Los demás                                            |
+---------------+------------------------------------------------------+
| 9030391       | Voltímetros                                          |
+---------------+------------------------------------------------------+
| 90303911      | Numéricos (digitales)                                |
+---------------+------------------------------------------------------+
| 90303919      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9030392       | Amperímetros                                         |
+---------------+------------------------------------------------------+
| 90303921      | Del tipo de los utilizados en vehículos automotores  |
+---------------+------------------------------------------------------+
| 90303929      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90303990      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903040        | Los demás instrumentos y aparatos, especialmente     |
|               | concebidos para técnicas de telecomunicación (por    |
|               | ejemplo: hipsómetros, kerdómetros, distorsiómetros,  |
|               | sofómetros)                                          |
+---------------+------------------------------------------------------+
| 90304010      | Analizadores de protocolo                            |
+---------------+------------------------------------------------------+
| 90304020      | Analizadores de nivel selectivo                      |
+---------------+------------------------------------------------------+
| 90304030      | Analizadores numéricos (digitales) de transmisión    |
+---------------+------------------------------------------------------+
| 90304090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90308         | Los demás instrumentos y aparatos:                   |
+---------------+------------------------------------------------------+
| 903082        | Para medida o control de obleas (""wafers"") o       |
|               | dispositivos, semiconductores                        |
+---------------+------------------------------------------------------+
| 90308210      | De prueba de circuitos integrados                    |
+---------------+------------------------------------------------------+
| 90308290      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903083        | Los demás, con dispositivo registrador               |
+---------------+------------------------------------------------------+
| 90308310      | De prueba de continuidad de circuitos impresos       |
+---------------+------------------------------------------------------+
| 90308320      | De prueba automática de circuitos impresos con sus   |
+---------------+------------------------------------------------------+
| 90308320      | componentes montados                                 |
+---------------+------------------------------------------------------+
| 90308330      | De medida de parámetros característicos de señales   |
|               | de televisión o video                                |
+---------------+------------------------------------------------------+
| 90308390      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903089        | Los demás                                            |
+---------------+------------------------------------------------------+
| 90308910      | Analizadores lógicos de circuitos numéricos          |
|               | (digitales)                                          |
+---------------+------------------------------------------------------+
| 90308920      | Analizadores de espectro de frecuencia               |
+---------------+------------------------------------------------------+
| 90308930      | Frecuencímetros                                      |
+---------------+------------------------------------------------------+
| 90308940      | Fasímetros                                           |
+---------------+------------------------------------------------------+
| 90308990      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903090        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90309010      | De instrumentos y aparatos de la subpartida no       |
|               | 9030.10                                              |
+---------------+------------------------------------------------------+
| 90309020      | De instrumentos y aparatos de las subpartidas nos    |
|               | 9030.31 ó 9030.39                                    |
+---------------+------------------------------------------------------+
| 90309030      | De instrumentos y aparatos de las subpartidas nos    |
|               | 9030.82 ó 9030.83                                    |
+---------------+------------------------------------------------------+
| 90309090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9031          | Instrumentos, aparatos y maquinas de medida o        |
|               | control, no "expresados ni comprendidos en otra      |
|               | parte de este capitulo;" proyectores de perfiles.    |
|               |                                                      |
|               | \[measuring or checking instruments/ appliances and  |
|               | machines/ nesoi/ profile projectors/ parts and       |
|               | accessories thereof\]                                |
+---------------+------------------------------------------------------+
| 90311000      | Máquinas para equilibrar piezas mecánicas            |
+---------------+------------------------------------------------------+
| 903120        | Bancos de pruebas                                    |
+---------------+------------------------------------------------------+
| 90312010      | Para motores                                         |
+---------------+------------------------------------------------------+
| 90312090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90313000      | Proyectores de perfiles                              |
+---------------+------------------------------------------------------+
| 90314         | Los demás instrumentos y aparatos, ópticos:          |
+---------------+------------------------------------------------------+
| 90314100      | Para control de obleas (""wafers"") o dispositivos," |
|               | semiconductores, o control de máscaras o retículas   |
|               | utilizadas en la fabricación de dispositivos         |
|               | semiconductores                                      |
+---------------+------------------------------------------------------+
| 90314900      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903180        | Los demás instrumentos, aparatos y máquinas          |
+---------------+------------------------------------------------------+
| 9031801       | Dinamómetros y rugosímetros                          |
+---------------+------------------------------------------------------+
| 90318011      | Dinamómetros                                         |
+---------------+------------------------------------------------------+
| 90318012      | Rugosímetros                                         |
+---------------+------------------------------------------------------+
| 90318020      | Máquinas para medición tridimensional                |
+---------------+------------------------------------------------------+
| 90318030      | Metros patrones                                      |
+---------------+------------------------------------------------------+
| 90318040      | Aparatos digitales de uso en vehículos automóviles   |
|               | para medida e indicación de múltiples magnitudes,    |
|               | tales como: velocidad media, consumos instantáneo y  |
|               | medio y autonomía (computadores de a bordo)          |
+---------------+------------------------------------------------------+
| 90318050      | Aparatos para análisis de textiles, computarizados   |
+---------------+------------------------------------------------------+
| 90318060      | Celdas de carga                                      |
+---------------+------------------------------------------------------+
| 90318090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903190        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90319010      | De bancos de pruebas                                 |
+---------------+------------------------------------------------------+
| 90319090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9032          | Instrumentos y aparatos para regulacion o control    |
|               | automaticos                                          |
|               |                                                      |
|               | \[automatic regulating or controlling instruments    |
|               | and apparatus/ parts and accessories thereof\]       |
+---------------+------------------------------------------------------+
| 903210        | Termostatos                                          |
+---------------+------------------------------------------------------+
| 90321010      | De expansión de fluídos                              |
+---------------+------------------------------------------------------+
| 90321090      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90322000      | Manostatos (presostatos)                             |
+---------------+------------------------------------------------------+
| 90328         | Los demás instrumentos y aparatos:                   |
+---------------+------------------------------------------------------+
| 90328100      | Hidráulicos o neumáticos                             |
+---------------+------------------------------------------------------+
| 903289        | Los demás                                            |
+---------------+------------------------------------------------------+
| 9032891       | Reguladores de voltaje                               |
+---------------+------------------------------------------------------+
| 90328911      | Electrónicos                                         |
+---------------+------------------------------------------------------+
| 90328919      | Los demás                                            |
+---------------+------------------------------------------------------+
| 9032892       | Controladores electrónicos del tipo de los           |
|               | utilizados en                                        |
+---------------+------------------------------------------------------+
| 9032892       | vehículos automóviles                                |
+---------------+------------------------------------------------------+
| 90328921      | De sistemas antibloqueo de freno (ABS)               |
+---------------+------------------------------------------------------+
| 90328922      | De sistemas de suspensión                            |
+---------------+------------------------------------------------------+
| 90328923      | De sistemas de transmisión                           |
+---------------+------------------------------------------------------+
| 90328924      | De sistemas de ignición                              |
+---------------+------------------------------------------------------+
| 90328925      | De sistemas de inyección                             |
+---------------+------------------------------------------------------+
| 90328929      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90328930      | Equipamiento digital para control de vehículos       |
|               | ferroviarios                                         |
+---------------+------------------------------------------------------+
| 9032898       | Los demás para la regulación o el control de         |
|               | magnitudes no eléctricas                             |
+---------------+------------------------------------------------------+
| 90328981      | De presión                                           |
+---------------+------------------------------------------------------+
| 90328982      | De temperatura                                       |
+---------------+------------------------------------------------------+
| 90328983      | De humedad                                           |
+---------------+------------------------------------------------------+
| 90328984      | De velocidad de motores eléctricos por variación de  |
|               | frecuencia                                           |
+---------------+------------------------------------------------------+
| 90328989      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90328990      | Los demás                                            |
+---------------+------------------------------------------------------+
| 903290        | Partes y accesorios                                  |
+---------------+------------------------------------------------------+
| 90329010      | Circuitos impresos con componentes eléctricos o      |
|               | electrónicos montados                                |
+---------------+------------------------------------------------------+
| 9032909       | Los demás                                            |
+---------------+------------------------------------------------------+
| 90329091      | De termostatos                                       |
+---------------+------------------------------------------------------+
| 90329099      | Los demás                                            |
+---------------+------------------------------------------------------+
| 90330000      | \[parts and acce. (not specified or included         |
|               | elsewhere in this chapter) for machines/ appliances/ |
|               | instruments or apparatus of chapter 90\]             |
+---------------+------------------------------------------------------+

List of U.S. Schedule B HS Codes

  -----------------------------------------------------------------------
  HS Code              Description
  -------------------- --------------------------------------------------
  9018110040           Electrocardiographs

  9018110080           Parts and accessories for electrocardiographs

  9018194000           Apparatus, functional exploratory examination& pts

  9018198020           Patient monitoring system, temperature, pulse,etc

  9018198030           Basal metabolism and blood pressure apparatus

  9018198035           Electroencephalographs and electromyographs

  9018198045           Ultrasonic scanning apparatus

  9018198050           Other electro-diagnostic apparatus, nesoi

  9018198060           Parts&accessories for electro-diagnostic apparatus

  9018200000           Ultraviolet or infrared ray apparatus, & pts & acc

  9018310040           Hypodermic syringes, with or without their needles

  9018310080           Syringes, with or without their needles, nesoi

  9018310090           Pts for syrings, with or without their needles

  9018320000           Tubular metal needles & needles for sutures &parts

  9018390030           Bougies, catheters, drains & sondes & pts & access

  9018390050           Cannulae and the like and part and accessories

  9018410000           Dental drill engines and parts and accessories

  9018490000           Inst & appln for dental science, & pts & acc,
                       nesoi

  9022190000           Apparatus base on x-ray for oth use,ex medical,etc

  9022294000           Appts, alpha,beta,etc radiation for smoke detector

  9022298000           Appts, alpha,beta,etc radiation for oth use, nesoi

  9024100000           Machines and appliances for testing metals

  9024800000           Machine&appliance,test hardness,strength,etc,nesoi

  9024900000           Pts, machine & appln, test hardness/strength, etc

  9025112000           Clinical thermometers liquid-filled

  9025114000           Thermometers liquid-filled, direct reading, nesoi

  9025194000           Pyrometers not combined with other instruments

  9025198040           Clinical thermometers, nt combind w oth inst,nesoi

  9025198080           Thermometers, nt combined with oth inst, nesoi

  9025200000           Barometers, not combined with other instruments

  9025800000           Hydrometers, hygrometers,psychyrometers,etc,nesoi

  9025900000           Pts, hydrometers,therometers,pyrometers, etc

  9026105000           Flow meter for meas/checking flow/level of liquids

  9026107000           Inst & apprts, meas/check flow/level of liq, nesoi

  9026200000           Inst & apprts, measuring/checking pressure

  9026800000           Inst measure/checking variable of liq/gases, nesoi

  9026900000           Pts, inst & apprts measure/check variables liq/gas

  9027100000           Gas or smoke analysis apparatus

  9027202000           Gas chromatographs

  9027204040           Electrical electrophoresis instruments

  9027205000           Liquid chromatographs

  9027209000           Chromatographs & electrophoresis inst, nesoi

  9027304040           Spectrophotometers using optical rad nonelectrical

  9027304080           Elec spectrometers & spectrographs etc., opt radtn

  9027308020           Spectroscopes using optical radiations, nonelec

  9027308080           Spectrometers & spectrograph,opt rad,nonelec,nesoi

  9027400000           Exposure meters

  9027502000           Thermal analysis instruments and apparatus

  9027504050           Photometers

  9027505000           Oth chem analysis instruments & apparatus, nesoi

  9027509000           Inst,physical/chem analysis opt radiation,nesoi

  9027801000           Nuclear magnetic resonances inst exc heading 9018

  9027802000           Mass spectrometers

  9027803100           Electrochemical instruments and apparatus,

  9027803200           Chemical instruments and apparatus, nesoi

  9027803500           Phys analysis inst, exc optical radiations, nesoi

  9027808000           Inst, measuring/checking viscosity etc, nesoi

  9027902000           Microtomes

  9027904030           Pts & access of schb 9027.30.4040 & 9027.30.4080

  9027904040           Pts & accessories of articles of schb 9027.40.0000

  9027904070           Pts & access of inst & appts for physical/chem etc

  9030100000           Inst for measuring/detecting ionizing radiations

  9030200000           Cathode-ray oscilloscopes&cathode-ray oscillograph

  9030310000           Multimeters

  9030390040           Apparatus to test voltage or current or resistance

  9030390080           Inst&appts for measuring/checking power, nesoi

  9030400000           Oth inst, specially designed for telecommunication

  9030810040           Inst to check semiconduct wafers &such that record

  9030810080           Inst & app with recording device, nesoi

  9030890080           Inst,measuring/checking electrical quantitie,nesoi

  9030904000           Parts for articles of subheading 9030.10

  9030908010           Parts and access for article of subhdg 9030.20

  9030908020           Pts & access of articles of schb subhdg 9030.31

  9030908030           Pts & access of artcl of schb subhdg 9030.39

  9030908040           Parts & access of articles of schb subhdg 9030.40

  9030908050           Parts and access of arti of subhdg 9030.82 or .83

  9030908060           Pts & access of articles of schb subhdg 9030,nesoi

  9031100000           Machines for balancing mechanical parts

  9031200000           Test benches

  9031300000           Profile projectors

  9031400020           Optical inst and app for inspecting photomasks

  9031400040           Optical inst for inspecting semiconductor wafers

  9031400060           Optical inst for inspecting semicond devices nesoi

  9031400080           Optical instruments and appliances nesoi

  9031800060           Equip, testing elec characteristics of engines

  9031800070           Equip, testing exc elec characteristics of engines

  9031800080           Measure/check inst,a ppln&machines,nesoi in chap
                       90

  9031900000           Pts, of mach nesoi in this chap,& profile projectr
  -----------------------------------------------------------------------

### *Source:* Industry Sector Analysis, *Medical Equipment*, 19 October 2001

If possible, disposable products are normally reused as a cost-saving
measure. This is possible because governmental and institutional
regulations are not as strict as in the U.S. However, with free-market
reforms and greater competition, disposable products have recently begun
to be discarded at a faster rate, causing the demand for new supplies to
increase somewhat.

To protect the health of its citizens, Argentina has restricted imports
of used medical equipment. According to Resolution 909, issued by the
Ministry of Economy in 1994, used goods must be refurbished for
importation into Argentina. Moreover, goods must be accompanied by
either a certificate issued by the original manufacturer or a technical
assessment certificate authenticated by the Argentine Embassy or
Consulate in the export country as proof of refurbishment.

Resolution 909 also requires that an official representative, appointed
by the original manufacturer ensure the availability of spare parts and
servicing in Argentina. An official local representative is not required
in order to import used goods directly into Argentina, although the
end-user (who has to maintain possession of the items for two years) is
solely responsible for the provision of spare parts and servicing.

## Australia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 17 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

There are no specific tariffs that apply to used or refurbished medical
equipment that do not apply to new medical equipment.

Any used or refurbished medical equipment must comply with the same
regulations that apply to new medical equipment. This includes any
relevant Australian standards and listing or registration with the
Therapeutic Goods Administration (TGA). For information on medical
regulations and the TGA, contact:

  ------------------------------------------- -----------------------------
  The Information Officer, Conformity         Tel: 61 2 6232 8673\
  Assessment Branch\                          Fax: 61 2 6232 8785\
  Therapeutic Goods Administration\           Email:
  PO Box 100\                                 glenn.street@health.gov.au\
  Woden ACT 2606\                             Website:
  Australia                                   www.health.gov.au/tga

  ------------------------------------------- -----------------------------

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc?*

> A third party cannot legally import the same device in
> used/refurbished condition without the device being subject to new
> listing or registration with the TGA because the TGA will have only
> approved the device for the original sponsor of the product. The third
> party will have to apply to the TGA for listing or registration of the
> used/refurbished device in Australia.

*Can public health institutions buy used or refurbished medical
devices?*

Health institutions are able to purchase used/refurbished medical
equipment with no restrictions. Preference is given to products that
come with quality assurance and warranties. Suppliers of
used/refurbished medical equipment are more likely to distribute
products for which there are available spare parts.

However, since the Australian market for medical devices is mature and
consumers are sophisticated, there is little demand for technologically
obsolete devices. It appears that much of the supply of used equipment
is being met by local health institutions with only a small amount being
imported. Therefore, there has been little or no increase in suppliers
or market for used equipment over the past few years. Major teaching
hospitals are unlikely to expose themselves to the increased risk of
purchasing used goods. Given the current strength of the U.S. dollar,
the economic viability of importing used equipment of suitable quality
into Australia is considered questionable at this time.

*Is there a market for used or refurbished medical devices?*

Demand for used medical equipment is limited. There is technically a
market for used or recycled equipment. However, this is not considered a
promising sector because hospitals and hospital groups often sell used
equipment among themselves. The equipment moves down the 'food chain'
from major hospitals to small private hospitals and out-patient clinics.

Technical advances and the desire to have the latest and best equipment,
even in small hospitals, is making used equipment redundant. An export
market of used equipment is developing with Australian distributors
exporting to Asia, the Pacific Islands and Papua New Guinea. In
addition, some equipment is being exported to overseas locations through
church groups and organizations such as Rotary International.

*If there is a market, what types of used or refurbished medical
equipment are in greatest demand?*

The market for used or refurbished medical equipment in Australia is
small, with limited prospects for U.S. suppliers. Best prospects lie in
the low-technology sector of the market such as furniture (for example,
beds), wheelchairs, and rehabilitation equipment.

## Austria 

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via Cable), October 22, 1998

There are no restrictions on the import of used equipment per se in
Austria. All imports of used equipment are treated the same as new. This
means that they carry the same duty and are required to be tested and
marked with the European 'CE' mark before being installed.

\[This cable generally addresses manufacturing and agricultural
equipment; applicability of these comments to medical equipment is
uncertain.\]

## Bahamas

###### General Market Condition: No Restrictions, but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via Cable), 4 April 2001

The Bahamas Ministry of Health provided the following information in
response to questions regarding the importation of used medical
equipment.

The Government of the Bahamas applies the same restrictions to both used
and new medical equipment. (Importation of new or used medical equipment
is subject to a 42 percent customs duty.)

It is not a policy of the Ministry of Health to purchase used and/or
refurbished medical equipment, implements, or devices. Bahamian public
and private sector health institutions prefer to purchase new equipment.

## Bangladesh

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 15 April 2002

The Government of Bangladesh imposes restrictions on the import of some
used medical equipment. Second-hand and reconditioned machines, which
would include medical products such as used X-ray machines, must be
imported with a certificate from an established international inspection
firm attesting that the equipment will last at least 10 years.

There are no special tariffs that apply to used or refurbished medical
equipment. Customs valuation of the equipment is normally taken from the
invoice presented by the importer.

The prospects in Bangladesh for American origin used medical equipment
are good. There is a particular demand for dental chairs with drill
systems, X-ray equipment, ultrasound machines, magnetic resonance and
CT-scan equipment, and electrocardiographs. Private clinics and
independent doctors have purchased used equipment, but have had
difficulty locating local suppliers. Hospitals in the public sector,
however, generally purchase new equipment.

## Barbados

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 6 June 2000 (Information confirmed 29 March 2002)

There are currently no restrictions on the importation of used and
refurbished medical equipment into Barbados.

The import duty applied to used or refurbished medial equipment is the
same as applied to new medical equipment. The tariff rate on medical
equipment varies between 5 percent to 20 percent depending on the type
of medical equipment. There is also a 1 percent environmental levy and a
15-percent value-added tax applied to imports of medical equipment.

Ministry of Health officials advise that there are no restrictions on
the importation of used medical or refurbished equipment by public
health institutions. However, based on past experience relating to
reliability and the conditions of used medical equipment, it is the
practice of the Ministry of Health to purchase new medical equipment.
The purchase of used medical equipment also does not adhere to the
procurement practices of the Government of Barbados.

Private sector health care professionals can purchase used or
refurbished medical equipment. However, the Ministry of Health needs to
be advised of all purchases of used medical equipment being imported
into Barbados.

There are no statistics available on the market for used or refurbished
medical equipment in Barbados. Based on the strong preference by
government and private sector health care professionals to purchase new
medical equipment, we do not foresee much market potential for used
medical equipment in Barbados.

## Belgium

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also the entry for the European Community.*

### *Source:* Report from CS Post (via E-Mail), 17 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment?*

No. Used medical equipment is treated identically as new medical
equipment regarding CE mark and import duties.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections, etc.?*

Yes, a third party can import the same device in used/refurbished
condition if it has the CE mark. There is of course the issue of
liability.

*Can public health institutions buy used or refurbished medical devise?*

Yes, but hospitals are more reluctant to purchase medical equipment or
to reuse medical devices because of liability issues. In Belgium, used
or refurbished equipment is sometimes used to train students. A lot of
used and refurbished equipment is exported to developing countries in
Africa and the former eastern countries.

*Is there a market for used or refurbished medical devices?*

Yes, if the refurbished medical devices are of a superior quality
compared with the existing medical devices. Belgian hospitals have the
reputation of using very high-tech medical equipment.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

High-tech equipment.

## Belize

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 5 April 2002

Based on information supplied by Belize's Assistant Comptroller of
Customs, Everard Lopez:

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

There are no special restrictions or tariffs applied to used and
refurbished medical equipment that are imported into Belize. A
10-percent import duty is levied on most of the new and used/refurbished
medical equipment imported into the country. A very small percentage is
exempted from import duty, a list of which may be obtained from the
Belize Customs Department. Local importers also pay an eight percent
sales tax and a one-percent environmental tax on all new and
used/refurbished medical equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Public Health institutions and individual companies can and do buy used
or refurbished medical devices.

*Is there a market for used or refurbished medical devices?*

Recent trade figures indicate that there is a growing market in Belize
for used and refurbished medical devices.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Based on recent import entry data, used lamps, chairs and optical
projectors for eye examinations are in the greatest demand in Belize.
Data indicate also that used medical equipment, which include universal
radios, graph units, monographic optical delivery beds, and konica with
stands are also in great demand.

## Bolivia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 23 April 2003

#### Regulatory Agency

The Ministry of Health and Sports is the regulatory agency for the
healthcare sector. Reporting to this ministry are the Viceministry of
Health and the Viceministry of Sports.

#### Projects and Decentralized Institutions:

-   Unidad de la Reforma de la Salud

-   Unidad Ejecutora del Fondo Nórdico

-   Proyecto de Salud Integrado (PROSIN)

-   Programa de Apoyo al Sector de la Higiene y Salud

-   Unidad del Escudo Epidemiológico y Apoyo a la Reforma de Salud (BID)

-   Comité Nacional de la Persona Discapacitada

-   Instituto Boliviano de la Ceguera

-   Instituto Nacional de Seguros de Salud (INASES)

-   Instituto Nacional de Salud Pública (INSP)

-   Central de Abastecimiento de Suministros (CEASS)

-   Seguros Delegados

-   Instituto Nacional de Laboratorios de Salud (INLASA)

-   Instituto Nacional de Salud Ocupacional

-   Escuela de Salud de La Paz

-   Escuela Técnica de Salud Boliviana -- Japonés (Cooperación Andina -
    Cochabamba)

-   Centro Nacional de Epidemiología y Salud Ambiental del Sur
    (CENESASUR)

-   Instituto Nacional de Medicina Nuclear

-   Instituto Boliviano de Biología de la Altura

-   Centro Nacional de Enfermedades Tropicales (CENETROP)

-   Central de Abastecimiento de Suministros (CEASS)

-   Lotería Nacional de Beneficencia y Salubridad

-   Servicios Departamentales de Salud

-   Instituto Nacional de Psiquiatría Gregorio Pacheco

-   Instituto Nacional Psicopedagógico

Healthcare in Bolivia is provided by both the public and the private
sector. The public sector health service providers are the following:

-   Servicios Departamentales de Salud

-   Caja Nacional de Salud

-   Caja Petrolera de Salud

-   Caja Bancaria Estatal de Salud

-   Caja de Salud de Caminos

-   Caja de Salud de la Banca Privada

-   Seguros Sociales Universitarios

-   Caja de Salud CORDES

Private sector providers include profit hospitals and clinics, and
non-profit hospitals and clinics. Approximately 75 percent of existing
patients are cared for by public institutions.

#### Import Regulations for Used/Refurbished Medical Equipment

The Government of Bolivia does not impose restrictions on the
importation of any kind of used/refurbished equipment. All imports of
used equipment are treated the same as new.

The market for used medical equipment has always been open for U.S.
products. In fact, a number of small businesses are looking for
suppliers of used/refurbished equipment because they find U.S products
more attractive for reasons of quality, easy access to spare parts and
quick maintenance, if required.

Public health institutions can buy used or refurbished medical devices.
To do so, they normally call for public bids with a deadline between 30
to 45 days to present proposals. Consequently, it is advantageous for
U.S. companies to have a local representative to keep them abreast of
new projects in the public sector

There has been special preference for used/refurbished medical
equipment, such as medical diagnostic systems, optical instruments,
anesthesia apparatus, operating room furniture, patient room furniture,
other hospital furniture, and surgical instruments and apparatus.

#### Import Duties and Taxes

A sworn declaration forms is required by the National Customs Office,
when a product does not require inspection by government inspection
companies. This form has a cost of 1 percent of FOB product value.

Product verification by the government's inspection companies has a cost
of 1.75 percent of the FOB product cost.

Importers must pay the respective customs tariff, as if new, which is 10
percent of the CIF price, plus a Value Added Tax of 14.94 percent.
Products that are classified as a "capital good" pay a duty rate of only
5 percent. While most industrial equipment falls into this category,
medical equipment does not.

#### Pre-shipment Inspection

Most medical equipment does not require inspection by the official
government inspection companies, SGS or Inspectorate, to determine the
real FOB value of the equipment before shipping. However, a sworn
declaration form is required by the National Customs Office.

The Government of Bolivia does not require pre-shipment inspection of
used medical equipment. The Bolivian Customs Office will inspect the
merchandise once it is in the country.

#### Distribution

Generally, foreign manufacturers have a local representative. The
representative can be exclusive or non-exclusive. Some dealers sell
several lines of equipment and some offer after-sale service, while
others do not. Manufacturers should be cautious in choosing their local
representatives. The government only buys products from accredited local
representatives.

Public sector purchases must be carried out in accordance with
Government Procurement Regulations (Normas Básicas) and the budget of
each agency. Purchases by the public sector exceeding US\$2,600 must be
made through public tenders or selective invitations to bid. Foreign
firms who wish to bid must appoint a local representative with a
Representation Agreement.

Purchases made by private firms or individuals are bought directly for
the importer from his stock of equipment, or imported from the
manufacturer through the representative.

#### Contact Information

##### Government Agencies 

Ministerio de Salud y Deportes\
Plaza del Estudiante sin número final el Prado\
Phone: (591-2) 249-2734\
Fax: (591-2) 249-2734\
Contact: Mario Ribera, Purchasing Manager

##### Trade Associations 

ASOFAR\
Pharmaceutical Association\
Phone: (591-2) 220-1788\
Fax: (591-2) 220-1811\
<asofar@kolla.net>\
Contact: Oscar Medina R.

National Chamber of Commerce\
Edificio Cámara Nacional de Comercio\
Piso 1\
Avenida Mariscal Santa Cruz No. 1392\
La Paz - Bolivia\
Phone: (591-2) 237-8606\
Fax: (591-2) 239-1004\
[www.BoliviaComercio.org.bo](http://www.BoliviaComercio.org.bo/)\
<cnc@boliviacomercio.org.bo>

National Chamber of Industry\
Avenida Mariscal Santa Cruz No. 1392\
Edificio Cámara Nacional de Comercio\
Piso 14\
Phone: (591-2) 237-4477\
Fax: (591-2) 236-2766\
<cni@caoba.entelnet.bo>\
[www.bolivia-industry.com](http://www.bolivia-industry.com/)

## Brazil

###### General Market Condition: Restricted

### *Source:* Brazil: Country Commercial Guide FY 2002

#### Best Prospects for Non-Agricultural Goods and Services---Sector: Medical Equipment and Devices

##### A New Market for Refurbished Equipment

Brazil approved a law that regulates the import of refurbished medical
equipment. Companies that are interested in this niche have to comply to
a rigid set of guidelines, including, date of refurbishment, accurate
adjustment & calibration. The refurbished equipment must meet the exact
same performance of new equipment. Also, the manufacturer must provide
technical assistance in Brazil or designate a local representative to
provide the service.

#### Trade Barriers, including tariffs, non-tariff barriers and import taxes---Import Licenses

##### Automatic License

As a general rule, Brazilian imports are subject to the 'automatic
import license' process. This procedure requires that the Brazilian
importer submits information concerning each import, including
description of the product as well as the harmonized tariff
classification number, quantity, value of the shipment, shipping costs,
etc. This information will be used for purposes of preparing the 'Import
Declaration' (locally known as the DI). Subsequently, all information is
fed into Brazil's customs computer system known as the SISCOMEX. The
Brazilian Foreign Trade Secretariat (SECEX) is the government agency
responsible for granting import licenses.

##### Non-Automatic License (LI) 

Whenever imports are subject to the Non-Automatic License (LI) regime,
the importer must provide information concerning each shipment to
Brazilian customs authority either prior to shipment or prior to customs
clearance. The required information includes a description of the
product as well as the harmonized tariff classification number,
quantity, value of the shipment, shipping costs, etc.

-   Prior to Customs Clearance: Products imported under the drawback
    regime, as well as imports destined to the free trade zones and the
    National Council for Scientific and Technological Development.

-   Prior to Shipment Clearance: Products subject to special controls
    from SECEX or which require approvals from other Brazilian
    government agencies. Such products may include: used products in
    general, products that enjoy import tariff reductions, imports that
    do not involve payment from importer to the exporter \-- e.g.,
    samples, donations, temporary admission, psychotherapeutic drugs,
    products for human or veterinary research; weapons and related
    products, radioactive products and rare earth metal compounds, crude
    oil, oil derivatives or other petroleum derivatives, anti-hemophilic
    serum, medications with plasma and human blood, products that may be
    harmful to the environment---e.g., CFC, mailing machines, stamp
    selling machines, airplanes, etc.

Shortly after feeding the SISCOMEX system information concerning a
specific shipment, the SISCOMEX system will indicate whether or not a
'non-automatic import license' is required.

### *Source:* Report from CS Post (via E-Mail), 17 May 2001

On February 15th 2001, ANVISA (National Health Administration Agency)
published resolution RDC nº 25, which regulates imports of used medical
equipment. The resolutation imposes strict requirements that used
equipment must meet before it can be imported into the country. Some of
the requirements include:

-   Registration with Brazil's *Vigilancia Sanitaria* agency. If the
    product does not require such registration, submit evidence to
    support your claim;

-   Obtain an import license. The license must state the country of
    origin, detailed information of product, name of manufacturer, model
    and technical specifications;

-   The equipment must be thoroughly cleaned and refurbished;

-   All parts and pieces subject to wear and tear must be replaced;

-   The equipment must be professionally calibrated to meet original
    specifications which must be certified by the original manufacturer;

-   New labels must be affixed and an instruction manual must be
    provided;

-   Submit the year the equipment was refurbished;

-   The equipment must pass thorough quality control tests; and

-   Make spare parts and components available in Brazil during the
    useful life of the equipment.

There are severe penalties for companies that do not follow the
requirements listed above, including assessment of stiff fines and even
confiscation of the equipment. Therefore, it is critical that U.S.
exporters of used medical equipment coordinate closely the transaction
with the Brazilian importer. We also strongly advise that U.S. companies
obtain the services of a reputable Brazilian customs brokerage firm with
significant experience related to imports of medical equipment.

For further information please contact

Jefferson Oliveira\
Business Development Specialist\
Rua Estados Unidos, 1812\
01427-002 - Sao Paulo -- SP\
Phone: 55-11-3897-4038\
Fax: 55-11-3085-9626\
E-mail: [Jefferson.Oliveira@mail.doc.gov]{.underline}

## Botswana

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 12 March 2002

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No. Used medical equipment imports are subject to the same tariffs as
new medical equipment. Used medical equipment that comes into Botswana
as donations to the public hospitals/institutions is generally exempted
from tariffs. There are no specific restrictions on the importation of
used medical equipment, but at the point of customs clearance, the
equipment is subject to rejection should if found to be significantly
out-of-date.

*Can public health institutions buy used or refurbished medical
devices?*

Yes.

*Is there a market for used and refurbished medical devices?*

Importation of used medical equipment is minimal. Most of the imported
used or refurbished medical devices imported to Botswana are donations
to public hospitals/institutions. Generally speaking, medical equipment
in Botswana is usually purchased new by the Ministry of Health through
the government tender process.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Not applicable.

## Cameroon

###### General Market Condition: No Restrictions, but Not Accepted in Public Tenders for Public Health Facilities

### *Source:* Report from CS Post (via E-Mail), 28 March 2002

According to Mr. Charles Tawamba, Technical Adviser to the Minister of
Economy and Finance. (prior to his current post, he was the Legal
Affairs Director in the Ministry of Commerce and Industrial Development
(MINDIC):

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

There are no special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Public health institutions cannot usually buy used or refurbished
medical devices on a government budget. The health strategy being
planned by the Government of Cameroon will pass management of district
hospitals to a community-based board of directors. The community, after
surveying its needs, will decide where and when to acquire medical
devices.

*Is there a market for used or refurbished medical devices?*

There is an important market for used or refurbished medical devices.
Cameroon is slowing emerging from a deep economic crisis that resulted
in reduced spending on health. Since Cameroon is eligible (Decision
Point reached) for the Highly Indebted Poor country initiative, funds
previously used to repay its debt will be reorientated toward health and
education spending and will result in increased spending on medical
devises.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

In the countryside, a dearth of medical equipment of all sorts exists.
Rural hospitals have a critical need for all types of medical equipment,
particularly laboratory tests equipment, hospitalization equipment,
surgical equipment, and feeding tubes and other intubation products.

### *Source:* Report from CS Post (via Cable), 13 March 2001

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no restrictions on the import of used/refurbished equipment in
Cameroon. However, used equipment imported from the United States is
often penalized due to overvaluation at the Cameroonian customs when
customs duties are assessed. The duty on used equipment imported from
the United States is calculated on the basis of the price of similar
equipment imported from European markets, not on the selling price in
the United States

*Can public health institutions buy used or refurbished Medical
devices?*

Used medical equipment is not accepted in public-sector tenders for the
supply of equipment and materials to government-owned public health
facilities. However, private clinics and religious hospitals have no
restriction on purchasing such equipment.

*Is there a market for used of refurbished devices?*

The Cameroonian market for used medical equipment is relatively small.
Germany has the largest market share with its Siemens brand. Cameroonian
medical establishments sometimes import used radiology and echography
medical equipment from European suppliers.

## Canada

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 2 May 2000

The content of ISA Medical 970901 (*see below*) concerning
used/refurbished medical equipment remains fairly current with the
following observations and additions:

Although we remain unable to quantify this market, it is fair to assume
that demand for used/refurbished medical equipment has grown in Canada
over the past three years. It remains minimal in comparison to the total
market. It is in the area of refurbishing for existing customers that
most market gains would have been achieved in recent years. Surgical
endoscopes, both rigid and flexible, is one popular product for
refurbishing for existing customers.

Equipment maintenance people in Canadian public hospitals have had to
face more budget cuts in the second half of the 1990s. They have learned
to use the Internet to access used/refurbished medical equipment
businesses on web sites that proliferate and are believed to conduct
more sourcing for in-house reconditioning. There is also an occasional
demand for used and refurbished equipment destined to backup support,
particularly in blood and bio-chemistry laboratories.

Some market gains have been made by private health care businesses in
Canada in the past few years, namely in the laboratory, diagnostic, as
well as in aesthetic and minor surgery fields. Many of these businesses
are strong potential buyers of used/refurbished equipment.

The large demand created by Canada's 950+ network of public hospitals is
essentially for new, state-of-the-art medical equipment.

Sources at Health Canada's Medical Device Bureau indicated that used
medical equipment refurbished for resale/exports to Canada would be
subjected to licensing like new equipment, unless the refurbisher is the
original manufacturer that originally obtained licensing for the
equipment in Canada. In these cases, the review for licensing clearance
would be conducted based only on the specification changes made to the
equipment.

### *Source:* ISA Medical, 1 September 1997 {#source-isa-medical-1-september-1997 .unnumbered}

Although minimal in volume, sales of used/refurbished medical laboratory
equipment may be expected to show growth over the next two years in
Canada.

#### Used and refurbished medical laboratory equipment  {#used-and-refurbished-medical-laboratory-equipment .unnumbered}

Difficult to quantify, sales of used and refurbished medical laboratory
equipment in Canada appear to be minimal in relation to total market
sales. The purchase of used and refurbished equipment does not fit well
with Canada's current public hospital procurement practices.
Amortization, manufacturers' warranties, personnel training, and long
term servicing arrangements constitute the most important buying
criteria. Some used and refurbished equipment may find a place in public
hospital laboratories for backup support, provided it can be serviced by
the same company that sells and services the newer, more advanced
equipment. This seems to be the case for blood and chemistry analyzers.
Only U.S.-made used and refurbished instruments appear to be purchased
by Canadian hospital laboratories.

Future privatization of healthcare delivery services in Canada could
affect the market for used and refurbished medical laboratory equipment,
presenting new opportunities. However, no major new legislation in favor
of privatization of healthcare in Canada is anticipated in 1997 and
1998. Market conditions are therefore not anticipated to change for at
least the next two to three years.

## Chad

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 1 July 1998 {#source-report-from-cs-post-via-cable-1-july-1998 .unnumbered}

There are no restrictions on the import of used equipment. All imports
of used equipment are treated the same as new equipment. There are no
exceptions. Chad imports substantial quantities of use and refurbished
equipment and goods, including clothing, shoes, ties, used vehicles,
heavy equipment, computers, office machines and business equipment, etc.
The importation of used equipment is expected to remain an important
sector of the economy.

## Chile

###### General Market Condition: No Restrictions, but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via E-Mail), 9 March 2001

#### Import Regulations For Used Medical Equipment

##### Trade Barriers

Chile generally has few barriers to imports or investment. Foreign firms
operating in Chile enjoy the same protection and operate under the same
conditions as local firms. The Chilean tariff rate for 2001 is currently
eight percent on nearly all products from most countries, although many
products from countries with which Chile has trade agreements enter with
lower or no duties. Duties on capital goods purchased for use in export
production may be deferred for a period of seven years and waived under
some circumstances. Imports are subject to the same 18-percent Value
Added Tax (VAT) as are domestic goods.

##### Customs Valuation

Chilean customs valuation uses the normal value of merchandise, without
special discounts, plus freight and insurance (CIF). Used goods are
valued by customs according to the current new value of similar
merchandise, estimates the actual value of the equipment, based
primarily on depreciation tables. The normal 8 percent duty will be
applied plus an extra charge for used equipment of 4 percent. All
imports are subject to the 18-percent Value Added Tax (VAT).

##### Pre-Owned (Used and Refurbished Medical Devices)

There are no restrictions/prohibitions to import used/reconditioned
medical equipment/devices into Chile. However, internal regulations of
public health institutions and lending banks may require that new
equipment be purchased. Large private clinics in Chile prefer to buy new
equipment and occasionally will purchase used equipment as long as it
does not endanger the life of a patient, i.e. electrical beds, etc.

Health institutions are able to purchase used/refurbished medical
equipment with no restrictions. Preference is given to products that
come with quality assurance and warranties.

##### Sanitary Code

Chile's Ministry of Health amended the Sanitary Code in March of 1997 to
authorize the Institute of Public Health (ISP) to regulate medical
devices.

These regulations classify medical devices, the same way it is done in
the United States by the FDA, with three classes based on risk to the
patient. This new system requires that devices have to be tested for
quality by a Chilean authorized testing facility and to receive from ISP
a Certificate of Quality before they can be sold in Chile. Devices must
have an ISP approval seal on their labels.

##### Additional Information

  ----------------------------------------- -----------------------------------------
  Ministerio de Salud Publica\              Servicio Nacional de Aduanas de Chile\
  (Ministry of Public Health)\              (Customs)\
  Instituto de Salud Publica de Chile\      Plaza Sotomayor 60\
  Registros---Control Nacional\             Valparaiso, Chile\
  Marathon 1000\                            Tel: 56-32-20-0500\
  Santiago, Chile\                          Fax: 56-32-23-0591\
  Tel: 56-2-239-1105 extension 640\         Web Site: [www.aduana.co.cl;]()
  Fax: 56-2-237-1504\                       [www.estado.cl](http://www.estado.cl/)\
  Web Site:                                 E-Mail: <informac@aduana.cl>
  [www.ispch.cl](http://www.ispch.cl/)      

  Ministerio de Salud Publica\              Patricia Jaramillo, Commercial Advisor\
  (Ministry of Public Health)\              U.S. Embassy Santiago\
  Mac-Iver 541, Piso 2\                     Tel: 56-2-330-3402\
  Santiago, Chile\                          Fax: 56-2-330-3172\
  Contact: Dra. Michelle Bachelet,          E-Mail: <patricia.jaramillo@mail.doc.gov>
  Minister\                                 
  Tel: 56-2-639-4001\                       
  Web site:                                 
  [www.minsal.cl](http://www.minsal.cl/)\   
  E-Mail: <info@minsal.cl>                  
  ----------------------------------------- -----------------------------------------

## China

###### General Market Condition: In transition from Prohibited to Restricted

### *Source:* Report prepared by the Office of Microelectonrics, Medical Equipment and Instrumentation (U.S. Department of Commerce), 25 August 2003

In early 1998 China barred the importation of a wide range of
electro-mechanical devices (including many medical devices). Early in
2003, China issued a decree, "Administrative Measures on Product
Inspection and Supervision of Imported Used Mechanical and Electrical
Products," which would lift the 1998 ban. Implementation of the new
decree, originally set for 1 May 2003, has been postponed until 1 August
2003. Implementation of the decree for medical devices may be even
further off according to conversations held between the U.S. Commercial
Service in Beijing and Chinese health officials.

Under the new decree, many used products, including used medical
devices, will be subject to a pre-shipment inspection and an arrival
inspection. Although a second decree was issued in late April 2003
discussing which items will be subject to the pre-shipment inspections,
many details about the standards and inspection procedures have yet to
be issued. Officials with the Department of Medical Devices of China's
State Food and Drug Administration (SFDA) have told U.S. Commercial
Service staff that the ban on importing used medical devices will not be
lifted until the standards for testing and administrative guidelines for
used medical devices are in place. SFDA is studying this issue and,
after their study is completed, SDA will set up registration procedures
for used medical devices with testing standards and administrative
guidelines. No timetable has been given for the reopening of the market
for used medical devices, but there is speculation that it might happen
in 2004.

### *Source:* IMI, 5 November 1998 {#source-imi-5-november-1998 .unnumbered}

#### Summary {#summary-1 .unnumbered}

The January 8 International Business Daily published a notice jointly
issued by four ministries and commissions tightening control over the
import of used machinery and electric products.

#### Text {#text .unnumbered}

From January 1, 1998, except for special needs with the approval of the
State Machinery and Electric Products Import and Export Office, all
import of used machinery and electric products are forbidden, regardless
of the source of foreign exchange, means of trade, and import channels.

Without approval, units with the right of foreign trade are not allowed
to sign contracts or binding agreements for the import of used machinery
and electric products.

Foreign exchange administration agencies and banks pay or sell foreign
exchange upon presentation of the 'Quota Products Certificate' issued by
the State Machinery and Electric Products Import and Export Office, the
'Certificate of Machinery and Electric Products Import,' or the
'Registration Form of Machinery and Electric Products Import.'

The customs office inspects and approves import of used machinery and
electric products upon presentation of the 'Certificate of Quota
Product,' 'Certificate of Machinery and Electric Product,' 'Import
Registration Form of Machinery and Electric Products,' and 'Import
Certificate' issued by the State Machinery and Electric Products Import
and Export Office and the Ministry of Foreign Trade and Economic
Cooperation with a used product note, and the 'Memorandum of the Import
of Used Machinery and Electric Product' issued by the State
Administration of Import and Export Commodity Inspection.' Violators
will be subject to treatment of relevant regulations.

Commodity Inspection Agencies conduct inspections on all the used
machinery and electric products approved by the government. The
Commodity Inspection Agencies issue 'Notice of Conditions of Import
Commodity Inspection' for the used machinery and electric products that
conform to the state safety and environmental protection enforced
criteria and the inspection criteria as stated in the contract.
Unqualified products will be subject to treatment according to relevant
regulations of commodity inspection.

Use of import documents for new machinery and electric products to clear
used machinery and electric products through customs is strictly
forbidden. If discovered, the products will be confiscated by Customs.
The customs tariff or other taxes and fees are to be charged based on 60
percent of value of the new product.

#### Comment {#comment .unnumbered}

The January 7 *People's Daily*, published the notice in part, and
mentioned the following products: used liquid pressure bulldozers,
diesel engines for ship use, CT for medical use, and X-ray diagnostic
instruments for medical use.

## Colombia

###### General Market Condition: Restricted

### Colombia : Country Commercial Guide FY 2000 {#colombia-country-commercial-guide-fy-2000 .unnumbered}

Import Licenses: Colombia has two types of import licenses. The most
common is a standard import registration form known locally as 'Registro
de Importacion,' which all importers must complete. These forms are for
record keeping/statistical purposes and are available at the Colombian
Foreign Trade Institute (INCOMEX). The other license applies to closely
monitored, sensitive products such as precursor chemicals and weaponry.
The majority of 'used' goods, such as personal computers, cars, tires,
and clothing, are effectively prohibited from import, and those that are
allowed (e.g., used medical equipment) are subject to prior licensing.

## Costa Rica

###### General Market Condition: No Restrictions, but Public Institutions Cannot Buy

### *Source:* Report from CS Post (via Cable), 18 March 2002 {#source-report-from-cs-post-via-cable-18-march-2002 .unnumbered}

The Costa Rican Government does not impose any restrictions on the
import of used medical equipment.

There is a strong preference for new medical equipment. Some private
clinics and independent doctors occasionally purchase used equipment.
Hospitals and clinics within the purlic sector, however, purchase only
new equipment, consistent with well established govermment policy.

There is a limited market for used medical equipment in Costa Rica. Used
equipment purchased in Costa Rica is usually refurbished by the
manufacturer or by an authorized dealer of the manufacturer. It is
common for refurbished equipment to carry a minimum six-month guarantee.
Used equipment buyers also require assurances that parts and maintenance
can be obtained locally.

There are no special restrictions or tariffs that apply to
used/refurbished medical equipment. Customs valuation of the equipment
is normally taken from the invoice presented by the importer. Costa
Rican customs has become concerned about the problem of intentional
undervaluation of products being imported into Costa Rica. Exporters and
importers can expect special scrutiny of documents for products entering
the country that do not reflect reasonable market value.

Used medical equipment imported during past several years includes X-ray
equipment, magnetic resonance equipment, electrocardiographs,
microscopes, centrifuges, ovens, spectrophotometers, blister packaging
for pharmaceutical products, sterilizers, dental chairs with drill
systems, and lately, linear accelerators, among other items.

## Croatia

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 28 March 2002 {#source-report-from-cs-post-via-e-mail-28-march-2002-1 .unnumbered}

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No special tariffs exist for importing used or refurbished medical
equipment. The import regime is the same as it is for the import of new
medical equipment. However, there is a restriction that no imported
medical equipment can be older than five years.

*Can public health institutions buy used or refurbished medical
devices?*

Public health institutions can buy used or refurbished but never or very
rarely do so. They are very sceptical about the quality, guarantees and
servicing of used products and they consider it to be a risky business.
Therefore, in almost cases, they avoid it.

*Is there a market for used or refurbished medical devices?*

Most medical equipment distributors do not work with used medical
equipment because they argue that the market is too small, and that
risks connected with this type of business too great. The only customers
interested in buying used medical equipment are small private
hospitals/enterprises which, faced with limited budgets, are prepared to
purchase such equipment. However, even then, the sale of used medical
equipment is done, not through distributors or local companies, but
through private connections. For example, when they hear about the
planned replacement of equipment in a certain hospital in Germany, they
buy off the old equipment.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

This small market demand described above includes the most expensive
equipment such as X-rays, ultrasound, and electrocardiograph devices.

## Czech Republic

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 4 April 2001 (Information confirmed 25 March 2002)

There are neither special restrictions nor tariffs that apply to used
medical equipment and not to new medical equipment. The same procedure
applies to the importation of new, used and refurbished medical
equipment. To import to the Czech Republic, a foreign producer must have
an importer in the Czech Republic. To release a medical device on the
Czech market, the manufacturer or importer must arrange for assessment
of conformity with essential requirements for medical devices. A
manufacturer or importer issues a written declaration of conformity on
compliance with technical requirements and abiding by the stipulated
conformity assessment procedure. In contrast to the practice applied in
the EU countries, where products that have been assessed as to their
conformity with the European Council directives bear the CE marking, in
the Czech Republic, the declaration of conformity, issued by the
producer or importer, is the proof of fulfilling the technical
requirements and the conformity assessment procedure. Besides this, the
manufacturer or importer assures distributors of the products in writing
that the declaration of conformity has been issued. A medical device
must meet medical and technical requirements determined by the
manufacturer for the whole period of its use in terms of health care
provision.

The Government Orders 180/1998 and 130/1999 stipulate medical devices
classification. According to this order, medical devices are divided
into the I, IIa, IIb, and III Classes according to their risk. The
highest risk devices, including active implantable sanitary medium
medical devices, are included in the iii Class. The vast majority of
devices are included in the I Class. For placing on the market a medical
device from the I Class, the manufacturer or importer makes an
assessment of conformity himself. For placing on the market a medical
device from the IIa, IIb, and III Classes, the manufacturer or importer
must arrange for conformity assessment by an authorized entity. Czech
Office for Standardization, Metrology and Testing publishes the list of
the entities authorized to assess the conformity in the Bulletin
(*Vestnik*). The Authorized Body assesses the conformity with technical
requirements and issues a certificate.

There are no restrictions for public health institutions with regards to
purchasing of refurbished medical devices. All health institutions can
only purchase medical devices and equipment that are certified by the
Czech Ministry of Health for the sale in the Czech Republic.

Czech authorities have no certifying experience with used or refurbished
medical devices, as no application for importation of used or
refurbished medical devices has been filed yet. However, due to
restricted financial sources of healthcare institutions, used or
refurbished medical devices may be saleable if price competitive to new
medical devices already in the market.

All medical devices imported to the Czech Republic must comply with
Czech standards, a warranty must be provided by producer, and service
and spare parts must be available during the whole life of the product.
Best prospects exist for but are not limited to X-rays, ventilators,
operation tables and other price competitive medical devices.

## Denmark

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 5 March 2001 (Information confirmed 4 March 2002)

Any used medical equipment that does enter the Danish market must carry
the CE mark, the obligatory mark allowing the manufacturer/ supplier to
circulate their products freely within the European market. In general,
there are no specific laws prohibiting the import of used medical
equipment other than general ones regarding health, safety and
environmental issues. Denmark, as a member of the EU, follows general EU
directives.

Public institutions can buy used and refurbished equipment but there is
little to no market for used and refurbished medical equipment devices
in Denmark.

Although there are no special restrictions or tariffs applicable for
used medical equipment that do not apply to new medical equipment, trade
associations and industry contacts agree that there is little to no
market for used medical equipment in Denmark. From major purchasing
authorities (local authorities, etc.) to local distributors, a common
consensus exists that only new medical equipment is considered
'adequate' for the Danish market.

## Dominican Republic

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 2 May 2003

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

No, there are no special restrictions for used equipment. Regarding
tariff, if the products final use will be in a public/government own
hospital, importers may receive import tax exemption. This is usually
specified in the purchase contract.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc?*

Medical equipment does not need to be registered with the local
authorities. American standards are currently accepted and respected by
the purchasing entities.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, they do. In fact, they prefer to purchase refurbished equipment
because of the reduced cost. Public/government hospitals usually buy
medical equipment through local distributors/importers; therefore,
American exporters should contact the distributors/importers instead of
the hospitals directly.

*Is there a market for used or refurbished devices?*

Yes, there is a good market for both used and refurbished devices, but
refurbished have more demand.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Hospital furniture (hospital beds, surgical tables) and electro-medical
and diagnosis equipment (Tomographs, Magnetone Resonance Imagining).

## Ecuador

###### General Market Condition: No Restrictions, but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via E-Mail), 3 May 2000 {#source-report-from-cs-post-via-e-mail-3-may-2000 .unnumbered}

There are no restrictions/prohibitions to import used/reconditioned
medical equipment/devices into Ecuador. However, internal regulations of
public health institutions require that they purchase new equipment.
Large private hospitals and clinics in Quito, Guayaquil and Cuenca
prefer to buy new equipment and occasionally will purchase used
equipment as long as it does endanger the life of the patient, i.e.,
electrical beds, etc. On the other hand, small private hospitals and
clinics in smaller cities favor used/reconditioned medical equipment of
all types, but U.S. companies are required to provide a 1 to 5 year
guaranty depending on the product. Although private clinics and
hospitals will abide to lack of spare parts, provision of same will
provide a competitive advantage. Best prospects for used equipment are
surgical beds and lamps, electrical beds, X-rays, monitors and
sterilizers.

The following companies have been identified as importers/distributors
of refurbished equipment:

Advance Biomedical Services / Contact: Jorge Ruiz, Manager\
Foch 147 y 12 de Octubre\
Quito, Ecuador\
Tel & Fax: 011-593-2-238-472\
(Importer/distributor of refurbished X-rays, anesthesia equipment,
ventilators, respirators)

BIO-IN S.A. Sistemas Medicos / Contact: Boris Toledo A., General
Manager\
Datiles y 3ra., Local 12\
Guayaquil, Ecuador\
Tel: 011-593-4-881-569; 881-592; 991-330\
Fax: 011-593-4-881-882; 881-331\
(Importer/distributor of general medical refurbished equipment,
including: X-rays, dialysis, electrical beds, sterilizers, anesthesia
equipment)

## Egypt

###### General Market Condition: Prohibited

### *Source:* Report from CS Post (via E-Mail), 14 April 2003 {#source-report-from-cs-post-via-e-mail-14-april-2003 .unnumbered}

According to a January 2002 Government of Egypt (GOE) decree, the
importation of used and refurbished medical equipment and supplies to
Egypt is banned. The ban does not differentiate between the most complex
computer-based imaging equipment and the most basic of supplies. This
ban is clearly stated in Import Certificates issued by the Egyptian
Ministry of Health (MOH) for any product. Specifically, the Customs and
the Pharmaceutical Politics Department of MOH, from which any importer
(company or individual) must obtain approval to release medical goods
from customs, will not approve clearance of used or refurbished medical
equipment.

In background, the GOE issued this ministerial decree after an
increasing number of attempts by Egyptian companies to import used and
refurbished medical equipment in the 1990's, when foreign companies
actively contacted many university-affiliated and other hospitals
offering a wide range of (primarily U.S. and U.K.-origin) used medical
items including endoscopes, X-ray machines, ultrasound scanners and
renal dialysis equipment. The proposals resulted in many concerns
regarding the safety of such imports and the prospect of unscrupulous
businesses taking advantage of inadequately informed customers in Egypt.

At present, even new medical equipment must be tested in the country of
origin and proven safe before it will be approved for importation into
Egypt. The above regulations also apply to medical equipment that is
being donated, not sold for profit.

## El Salvador

###### No Restrictions (except for Fetal Abortive Products), but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via Cable), 21 April 2003  {#source-report-from-cs-post-via-cable-21-april-2003 .unnumbered}

*Are there special restrictions or tariffs that apply to used medical
equipment but do not apply to new medical equipment?*

No additional restrictions are applied to imports of used or new medical
equipment, and each receives the same treatment. Medical equipment
imports are not required to pay more import tariffs, other than the
general 13-percent value-added tax.

*If a manufacturer or its agent has registered a medical device in the
country, can a third part legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections, etc.*

All used and new medical equipment distributors have to register their
products with the following health agencies:

-   Ministry of Health of El Salvador\
    Calle Arce no. 827,\
    San Salvador\
    El Salvador, Central America\
    Tel: 011-503-221-0966

-   Consejo Superior de Salud (Junta De Vigilancia)\
    Inicio Paseo General Escalon,\
    Frente a El Salvador Del Mundo\
    San Salvador\
    El Salvador, Central America\
    Tel: 011-503-245-3885\
    Fax: 011-503-298-2576

After registration, the importer must still comply with the normal
registration and certification processes by the Ministry of Health.

More information about importation requirements can be found at the
following website:

www.mspsa.gob.sv/importaciones.htm.

*Can public health institutions buy used or refurbished medical
devices?*

The Ministry of Health and the Social Security Administration buy new
medical equipment through an open bidding process, according to general
rules governing government acquisitions. Purchases of used and/or
refurbished equipment by public institutions are rare, and must be
approved by the Ministry of Health. More often, used equipment is
donated to public institutions.

*Is there a market for used or refurbished medical devices?*

According to medical equipment distributors, new equipment dominates
with 80 percent of the market, and used or refurbished equipment
supplies the remaining 20 percent. This ratio has remained steady for
the last several years.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

In El Salvador, there is substantial demand for cardiac monitors,
ultrasound equipment, x-ray equipment, surgery tables and beds, magnetic
resonance imaging apparatus, and diagnostic imaging equipment.

### *Source:* Report from CS Post (via Cable), 4 April 2000 (Information confirmed, 21April 2003) {#source-report-from-cs-post-via-cable-4-april-2000-information-confirmed-21april-2003 .unnumbered}

#### Post Review of IMI, 5 November 1998 (see below) 

Post reviewed information extracted from the IMI report and found the
information on El Salvador is up to date, but would like to complement
the report with the following information:

#### Purchases by Public Hospitals and Clinics {#purchases-by-public-hospitals-and-clinics .unnumbered}

Post would like to clarify that public hospitals and clinics do not buy
used or refurbished equipment as a prevailing practice. It is not a
written law or regulation. No change in this practice is expected. The
Ministry of Health purchases medical equipment through bids, and
although technical terms generally specify new equipment, the Ministry
of Health has authorized the purchase of used equipment on occasion. The
Ministry of Health also regulates the donation of used, refurbished, or
new medical equipment. These practices do not apply to El Salvador's
private hospitals or clinics.

#### Market share {#market-share .unnumbered}

Medical equipment distributors estimate that the market share for
used/refurbished equipment is 20 percent versus 80 percent market share
for new equipment. They project that the best prospects for used
equipment are in image diagnosis, mainly X-rays and tomographic
equipment used to provide mammograms.

#### Prohibited medical products and equipment  {#prohibited-medical-products-and-equipment .unnumbered}

Imports of fetal abortive products continue to be explicitly prohibited
by law.

#### Import regulations and tariffs {#import-regulations-and-tariffs .unnumbered}

Used products are treated the same as new products for the purpose of
importation. Used and new medical equipment are free of import tariffs;
only a 13 percent value added tax is applied.

#### License requirements {#license-requirements .unnumbered}

Currently, no specific license is required to import medical equipment.
However, post understands that the GOES' health sector modernization
plan will require that every sector (public and private) involved in the
supply of medical equipment and health services (clinics, hospitals,
distributors, importers, producers, etc.) Must register with the
ministry of health, and that only equipment that meets the standards set
by the ministry of health will be allowed for importation. The goes
expects to implement the plan before 2002.

### *Source:* IMI Medical, 8 November 2000

#### Summary

U.S. companies dominate El Salvador's medical equipment sector. In 1995,
U.S. market share reached 72.9 percent, dropped to 66.8 percent in 1997
and rose once again to 79.4 percent in 1999. El Salvador's public and
private hospitals and clinics prefer U.S. products due to their price,
quality and geographic proximity. The importation of U.S. medical
equipment is not restricted and no tariffs are applied for the
introduction of medical equipment into the country. The only applicable
tax is the 13 percent value added tax.

#### Best sales prospects

According to our survey, El Salvador is a good market for all types of
medical equipment. Government hospitals, hospitals belonging to the
Instituto Salvadoreo del Seguro Social (ISSS), hospitals under the
military hospital, large private hospitals (40 beds or more), and some
clinics are excellent markets for new equipment. While small private
hospitals, particularly those outside of san Salvador, provide a good
market for new equipment, they prefer refurbished equipment in order to
reduce costs. In general, good sales prospects are as follows:

  -----------------------------------------------------------------------
  Harmonized System         Product
  ------------------------- ---------------------------------------------
  9018.13.00                Magnetic Resonance Imaging Apparatus

  9018.19.40                Equipment for Diagnostic by Images

  9018.19.55                Cardiac Monitors

  9018.19.55                Vital Signal Monitors

  9018.90.60                Equipment for Laparoscopic Surgery

  9018.90.60                Boxes for Abdominal Hysterectomy

  9018.90.40                Pediatric and Adult Biaricular Stethoscopes

  9019.10.00                Respirators

  9019.20.00                Respiratory Ventilators

  9022.30.00                X-Ray Equipment

  9026.10.20                Infusion Pumps

  8421.12.00                Hospital Dryers

  8450.11.00                Hospital Washers

  9402.00.00                Surgery Tables

  9402.90.20                Surgery Beds

  9405.10.00                Ceiling Lamps
  -----------------------------------------------------------------------

#### Competitive Situation

There are two basic market types: new equipment and refurbished
equipment. The first is the largest, accounting for approximately 80
percent of total sales, and is concentrated in the metropolitan areas of
san Salvador, Santa Ana and San Miguel. This market looks more for
quality, durability, maintenance and availability of spare parts and
accessories rather than price. The refurbished equipment market is
concentrated outside of san Salvador and in small hospitals within San
Salvador. These institutions generally consider price as the main factor
when purchasing equipment. Customers for both of these markets tend to
purchase locally and directly although there are a number of small
hospitals and clinics that prefer to purchase overseas due to the high
cost that local suppliers add to the price of the product.

The key to entering the market is to offer competitive quality, prices
and post-sale services. It is also prudent to appoint a local supplier.
There is a market for new equipment, as well as for refurbished
equipment, which is generally sold to small hospitals. In general,
products with favorable sales potential include: ceiling lamps,
respiratory ventilators, respirators, equipment for intensive care
units, x-ray equipment, equipment for image diagnosis, cardiac monitors,
magnetic resonance, equipment for laparoscopic surgery, macro- and
micro- infusion pumps, vital sign monitors, boxes for abdominal
hysterectomy, pediatric and adult biaricular stethoscopes, surgery
tables, surgery beds, and hospital washers and dryers. The products
covered by this report correspond to the harmonized system sub-chapters:
901111 to 901210; 901320 to 901820; 901839 to 901920; 902150 to 902290.

The Ministry of Health only purchases new medical equipment; refurbished
or used equipment is accepted on a donation basis only. The Ministry of
Health purchases medical equipment based on hospital needs. To calculate
the hospital's medical equipment needs, doctors and hospital personnel
present reports to the Ministry of Health. While it is not necessary to
have a local supplier in order to participate in the medical equipment
bids offered by the Ministry of Health, it is highly recommended.

Large, private hospitals prefer to purchase new medical equipment from
companies that offer good quality and post-sale services, while small-
and medium-sized hospitals purchase new and refurbished medical
equipment. Medium and smaller hospitals have observed that local
suppliers offer medical equipment products at prices 300 percent over
the U.S. price. Approximately 65 percent of small hospitals prefer to
purchase their equipment directly from the U.S., and particularly Miami,
due to its geographic proximity, competitive prices viz. Local
suppliers, importing facilities, and common language.

## Ethiopia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 19 June 1998 (Information confirmed 28 March 2001) {#source-report-from-cs-post-via-cable-19-june-1998-information-confirmed-28-march-2001 .unnumbered}

There are no restrictions on the import of used equipment in Ethiopia.
Importation procedure is the same as for new. The Ethiopian custom
authority accepts only factory price.

No categories of equipment are restricted.

The used equipment market in Ethiopia is very good. Due to the shortage
of foreign currency in Ethiopia, the private sector especially is more
geared towards used equipment. U.S. equipment has a good reputation in
Ethiopia for durability and performance, so U.S. firms engaged in used
equipment export can take advantage of this growing market.

## European Union

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for individual members states of the European Union.*

### *Source:* Belgium ISA Medical, 6 March 2000 (Information confirmed 4 March 2002) {#source-belgium-isa-medical-6-march-2000-information-confirmed-4-march-2002 .unnumbered}

#### European Union (EU) Directives regarding used medical equipment {#european-union-eu-directives-regarding-used-medical-equipment .unnumbered}

The EU Directives have become instrumental in promoting free trade and
mutual recognition amongst EU member states.

One piece of legislation promoting uniform requirements for medical
devices took effect in January 1995. This legislation (93/42/EC)
requires all medical devices, regardless of the proposed use, to carry
the CE mark before entering the European market. In order to gain such a
mark, a device must pass a regulatory assessment determining whether it
is in conformity with EU standards. In addition, the manufacturer is
required to make specific information available as to proper and safe
use. The Directive requires the manufacturer to specify how a device is
to be used, taking into consideration the 'training and knowledge of the
potential users.' The appropriate corresponding information for use must
be contained in the packaging or labeling of the device. The Directive
specifies that the device must be marked 'single use' if that is the
manufacturer's intended use of the product. The Directive warns the
manufacturer that if the product's 'intended purpose' is not immediately
clear to the user, the manufacturer must clearly state it on the
packaging, thus re-emphasizing the need for specific labeling so as to
avoid misuse. Thus the Directive clearly identifies the liability for
product deformity or malfunction as residing with the manufacturer and
it outlines the limits of the manufacturer's warranty.

Once a device gains the CE mark, EU law prohibits member states from
placing any further restriction on its movement within the EU.
Accordingly, once a device has passed the regulatory assessment, the
manufacturer's intent for the use of the device has been accepted and
deemed appropriate for sale within the EU. This assertion means that the
manufacturer's warranty for sale can only extend as far as the first use
of the device.

This warranty argument may only apply, however, if the manufacturer has
clearly delineated the intended single use in accordance with the
Directive. Accordingly, the manufacturer may not specify that the device
may be re-used if the manufacturer does not have data illustrating that
the device will continue to comply with the Directive upon re-use.
Without such data, the device will not receive a CE mark and if the
device did enter the market in this fashion, the manufacturer would be
in violation of the Directive.

### *Source:* Report from CS Post (via Cable), December 24, 1996 (Information confirmed 4 March 2002) {#source-report-from-cs-post-via-cable-december-24-1996-information-confirmed-4-march-2002 .unnumbered}

\[This cable reported on discussions with EU official regarding the need
for imported used equipment to obtain a CE mark (i.e. are subject to
inspection and surveillance). Devices that entered the European Union
prior to the CE-mark requirement are grandfathered in and can be resold
on the EU market without first obtaining a CE mark. Identical used items
cannot be imported, however, unless they first receive a CE mark---even
if such devices were legally imported into the European Union prior to
the adoption of the regulation requiring the CE mark. This rule places
importers at a disadvantage compared to European resellers since sale of
used equipment within the EU requires no inspection, surveillance or CE
mark if such equipment met regulatory requirements at the time of its
original sale. The importance of this issue is gradually fading as
medical devices produced before the 1995 introduction of the CE mark
reach the end of their useful life.\]

## Finland

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via Cable), 6 March 2000 (Information confirmed as still valid, 25 March 2002)

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

No, Finland applies the EU directive on medical devices to both new and
used equipment.

*Can public health institutions buy used or refurbished Medical
devices?*

Yes, they can.

*Is there a market for used of refurbished devices?*

The market for used of refurbished devices is very small in Finland. The
tendency is to buy new equipment directly from equipment manufacturers
or distributors. Old or refurbished equipment is sold/exchanged directly
between hospitals and other healthcare institutions. In most cases old
equipment is donated/sold to Russia and the Baltic states.

*Best prospects?*

Equipment with a long lifetime---imaging equipment, for example.

## France

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 21 March 2002

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No restrictions, but CE mark is required.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, but hospitals are reluctant to buy used equipment for liability
issues.

*Is there a market for used and refurbished medical devices?*

For the two reasons above, not really, very marginal. Nevertheless,
France should still be considered by American companies whishing to
export used medical equipment to French-speaking Africa, as some trading
companies headquartered in France have extensive distribution networks
throughout French speaking Africa.

## Gabon

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 6 July 1998 {#source-report-from-cs-post-via-cable-6-july-1998 .unnumbered}

Since the devaluation of the CFA Franc in 1994, there has been a
significant increase of imports of used equipment, especially cars on
the Gabonese market. There are no restrictions on the import of used
equipment into Gabon.

## Germany

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from Post (via E-Mail), 17 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment but do not apply to new medical equipment?*

No restrictions, but CE mark required.

*If a manufacturer or its agent has registered a medical device in the
country, can a third part legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections, etc.*

According to two firms that handle used medical equipment in the German
market, a used device is subject to new CE marking and conformity
assessment, etc., if it is going to a new end-user. Only in cases where
the end-user is exactly the same can a medical product be refurbished
without new certification procedures. Thus, both firms are strict
service providers, that is, they take medical equipment from their
clients, refurbish it and hand it back to the very same clients; they do
not sell to third parties. Even when equipment is returned to the same
client, there are strict regulations governing the refurbishment, i.e.,
not more than 50 percent of the product should be modified otherwise it
is regarded as a new product and the refurbisher as a manufacturer.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, hospitals can buy used/refurbished equipment but are rather
reluctant to do so; they prefer to buy state-of-the-art, new products.

*Is there a market for used or refurbished medical devices?*

The German market for refurbished equipment is rather limited. Still,
there are a number of brokers/trading companies with worldwide
activities that may be interested in working with U.S. exporters.

### *Source:* International Marketing Insight, 26 March 2002 (Updated 17 April 2003)

\[Note: this report is primarily discussing the re-use of single use
devices, but see concluding paragraphs regarding the trade fair for used
equipment.\]

There are no restrictions on the import of used equipment into Germany.
New and used equipment fall under the same custom tariff categories
(category number: 9018), and the same safety standards apply for both
used and new products. In particular, CE marking is required for
marketing both new and used medical equipment in Germany.

Traditionally, there has hardly been any market potential for
refurbished equipment in Germany because of the existing strict medical
product laws and because German buyers have a strong preference for new
products. Recently however, and as a result of strong cost-containment
pressures following the Health Reform Laws, industrial and commercial
customers have positively responded to the refurbishing of medical
products. At a conference organized by the German subsidiary of a U.S.
provider of refurbished medical equipment, the German medical industry
concurred in principle on the advantages of refurbished equipment,
provided the highest quality control standards are applied.

There was a consensus that the field of invasive cardiology was
particularly suitable for refurbishment. While Class I medical products
such as heart catheters and pacemakers, are subject to extremely
stringent quality requirements and can only be refurbished by specialist
firms in the context of a Quality Management system according to DIN EN
ISO 9001 and DIN EN 46001, Class II and III products such as suction
tubes and oxygen masks, can be refurbished in hospitals in a fully
automated process. The German medical industry, under great
cost-containment pressures, has realized that refurbished medical
equipment can result in great procurement cost savings. Thus a five-time
refurbishment of 2,920 gastro gavage syringes saves a German hospital
approx. \$ 13,666 on average and reduces the hospital's waste disposal
volume by 567 kilograms. Thus, the German market for refurbished
equipment is actually growing. U.S. suppliers have to ensure, however,
that a specific medical device has been refurbished according to
standards outlined in the revised German Medical Products Law
('*Medizinproduktegesetz-MPG*;' 2nd revision in effect as of January 1,
2002) and its respective Medical Products Operations Ordinance
('*Medizinproduktebetreiberverordnung*'). These tighten controls
compared to the Medical Products Operations Ordinance of June 1998, in
view of consumer protection and the current lobbying of industry
associations against the refurbishing of so-called medical
'disposables.' The German government is promoting refurbishing for
cost-containment purposes and has tightened controls, as per the revised
ordinance, on some of the loopholes contained in the previous
regulations. Revisions include, amongst others:

-   A change in definition of 'bringing to market' (cf. Para 3, no. 11
    MPG);

-   A revised definition of 'refurbishing' in Para 3, no. 14 MPG;

-   A regular conformity assessment applying to those who do not return
    refurbished equipment to the previous user but sell it to third
    parties (Para 10, section 3 MPG);

-   Mandatory registration with the respective authorities (Health
    Ministry and BfArM) when refurbishing for third parties;

-   Inclusion of external service providers in the quality control
    process (Para 26, section 1 MPG); and

-   Amendments to the authorization for refurbishing/maintenance (Para
    37; section 5 MPG).

Requirements for the refurbishing of medical products under the Medical
Products Operations Ordinance are listed in Para 4, section 2 MPG,
mentioning appropriate procedures and the security and health of
patients, users, or third parties as top priority. Requirements include:

-   Validated Refurbishing.

-   Validated Packaging.

-   Validated Sterilization Procedures.

-   Refurbishing according to the RKI guideline. Recommendations of the
    Workgroup for Hospital Hygiene and Infection Prevention at the
    Robert Koch Institute (RKI), Berlin, formed the basis of the revised
    law. The so-called RKI guideline is available on the institute's
    website at www.rki.de and has been published in the German Federal
    Health Register.

-   Liability for the health and functional safety of the refurbished
    products (i.e., the refurbisher takes on the product liability from
    the manufacturer).

-   Quality management system according to DIN EN ISO 9001 and DIN EN
    46001.

Refurbished medical products do not need a new CE certification in cases
where the user outsources refurbishing and a special documentation
safeguards that the refurbished products are returned to the user, i.e.,
that there is no change in ownership.

Refurbishing of medical products focuses on the following sectors:
Electro-physiology; heart surgery; endoscopy; ophthalmic surgery;
neurology; urology; heart catheters; digital imaging/angiography;
anesthesia; intensive care; general surgery. Excluded from refurbishing
are, for example, pressure gauge syringes; spiral lead wires;
teflon-coated lead wires; locks and conductors; Olbert-PTA catheters;
Wilson-Cook, Endo-Flex and Dispomedica-brand endoscopy balloon
catheters; lithotomy baskets; ultrasound catheters, Endo units such as
clip applicators; spreaders; Endo shears; plastic implants.

The largest companies in the German refurbished medical equipment market
are Remed and Vanguard. Market leader Remed of Friedeburg has approx.
250 customers, mainly hospitals, universities and individual practices,
under contract and according to their press spokesperson, expects strong
growth over the next few years. Even though currently, roughly 30
percent of the German hospitals refurbish their medical equipment
in-house, Remed expects an increase in outsourcing as a less expensive
alternative. Remed has refurbished over 250,000 medical products and
over 1,000 different medical product categories over the past years.
Remed maintains a website at www.remed.de.

Table 1: Number of Units Refurbished by Remed

  ---------------- ---------- --------- ---------- ------------ ------------
                   1997       1998      1999       2000         2001

  Diagnostic       22,934     40,630    59,871     69,381       79,129
  Catheters                                                     

  Lead Catheters   3,007      5,281     6,472      7,991        10,338

  EPU Catheters    4,117      5,421     9,796      12,379       19,212

  EPU Cables       24         238       2,112      3,680        8,563

  Rejects          7,889      13,883    32,658     30,151       49,724

  Total No. of     35,615     59,241    88,542     110,989      136,225
  Refurbished                                                   
  Units                                                         
  ---------------- ---------- --------- ---------- ------------ ------------

Source: Remed

U.S. subsidiary and Berlin-based Vanguard GmbH Medical Services has
successfully refurbished medical equipment in Germany since 1998 and now
counts over 100 hospitals as clients. According to their chairman Robert
Schroedel, the validated refurbishing can result in substantive
economies of scale and savings, estimated at more than 500,000 million
Euro annually for all of Europe, several million Euro for large
hospitals or university clinics in Germany and 45,000 Euro annually for
smaller offices and medical institutions. Vanguard Germany is currently
refurbishing over 400 different medical products in validated
procedures. See also their website at www.vanguard.de.

Participation in German trade fairs is one of the most cost-effective
ways of testing the market's receptivity to a product, investigating
competitors and of finding customers or potential agents and
distributors. German trade fairs, due to their international
significance and large attendance numbers, provide an excellent vehicle
for introducing new technologies and products and present a gateway to
both the markets of the EU and eastern Europe. Unlike most North
American trade shows, the typical German fair is much larger, represents
virtually the entire industry, and is a highly successful sales point.
German trade shows attract heavy attention from worldwide buyers. The
following German trade show is establishing its reputation as the major
European trade show for refurbished equipment. It is international in
scope, giving visitors, buyers and exhibitors alike the foundation
needed to start business relations.

As per your cable request of March 24, I reviewed the current entry for
Germany and found that the information is still correct and up-to-date,
except, of course, for the trade show dates. RESALE 2003 just took place
(April 14-16) in Nueremberg, and the next RESALE is scheduled for April
2004, also in Nuremberg (exact dates tbd). This year\'s show featured
more than 500 exhibitors presenting over 150,000 products.

**Name:** *RESALE: Iternational Trade Fair for Used Machinery and
Equipment*\
**Location:** Nuremberg, Germany\
**Dates:** 26--28 April 2004

**Product Groups:** Machinery and equipment for the following
industries: Building, Disposal, Energy Engineering, Food Processing,
General Industrial, Medical Devices and Equipment, Metalworking,
Packaging, Plastics Processing, Printing, Recycling, Textiles, Timber
Processing, Utility Vehicles.

The show is an annual, trade-only event. Over 500 exhibitors presented
more than 150,000 products at the show in 2003. According to organizer,
large section with medical equipment.For further information on
exhibiting or visiting the show, please contact:

Hess GmbH\
Rieslingweg 10\
76356 Weingarten, Germany\
Phone: 49-7244-7075-0\
Fax: 49-7244-7075-50\
Email: info@resale2002.de\
Internet: www.resale2003.de (contains list of exhibitors;
industry-specific) (Please note that interested U.S. suppliers can enter
their offers on this English-language website free of charge.)

For specific questions regarding the export of refurbished equipment to
Germany or the marketing of refurbished equipment, please contact:

Mrs. Anette Salama\
Sr. Commercial Specialist\
U.S. Commercial Service Duesseldorf\
U.S. Consulate General\
Willi-Becker-Allee 10\
40227 Dusseldorf, Germany\
Phone: 49-211-737-767-60\
Fax: 49-211-737-767-67\
Email: anette.salama@mail.doc.gov

## Ghana

###### General Market Condition: No Restrictions, but Government Health Institutions Are Discouraged from Purchasing

### *Source:* Report from CS Post (via Cable), 2 March 2002

There have been no changes over the past year in import regulations for
used medical equipment in Ghana.

Ghana does not have explicit import restrictions or tariffs that apply
specifically to used or refurbished medical equipment or used equipment
in general. As a matter of policy, government health institutions are
discouraged from purchasing this equipment. Apart from assessment of
value, customs officials treat all imported equipment in the same way as
new equipment.

Used basic medical equipment such as hospital beds, wheelchairs,
trollies and furniture, and items that are not high technology are more
often purchased by the private sector. Government institutions tend to
purchase items that have a higher technology component. Institutions can
also accept used or refurbished medical equipment as gifts from donors.
One disadvantage of acquiring used or refurbished medical equipment
cited by officials is the frequent absence of operation manuals,
appropriate training, and spare parts.

The market for used or refurbished medical equipment in both public and
private medical institutions is generally limited. Private health
institutions, which are increasing in number, present the greatest
potential for growth in that market. Because of the lack of local
financing resources, interested u.s. firms that can offer some financing
in addition to warranty, spare parts, and training to support the
equipment can best take advantage of this opportunity.

The major types of used or refurbished medical equipment in greatest
demand include scanners, hospital beds, wheel chairs and furniture,
ultra sound, sterilizers, X-ray equipment, and laboratory equipment,
such as autoclaves.

## Greece

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via Cable), 2 March 2002 {#source-report-from-cs-post-via-cable-2-march-2002-1 .unnumbered}

In general, Greece does not apply any restrictions on imports of used
equipment and machinery, provided it has the CE mark and complies with
European Union safety and operations regulations. More specifically,
regulations for used medical equipment are governed by EU regulations:
90/385 EEC, 93/42 EEC, 98/79 EC. No special restrictions or tariffs
apply to used medical equipment that does not apply to new medical
devices.

Despite the absence of restrictions on the purchase of used medical
equipment, there does not appear to be much demand for such equipment in
the Greek market.

However, some private health institutions, medical laboratories, and
small to medium-sized clinics are purchasing used or refurbished dental
equipment, scanning devices, ultra-sound and analytical equipment. Such
purchases appear infrequent and isolated.

## Guatemala

###### General Market Condition: No Restrictions

### *Source:* ISA Medical, 1 September 1997 {#source-isa-medical-1-september-1997-1 .unnumbered}

Approximately 20 percent of medical equipment imported into Guatemala is
used or reconditioned equipment. This equipment consists of, but is not
limited to, portable X-ray machines, ultrasound equipment, anesthesia
equipment, operating tables, and surgical equipment. About 90 percent is
bought directly in the United States by physicians opening small
hospitals. Clinics and small health care facilities known as
'*sanatorios*' usually purchase their equipment from large Guatemalan
hospitals or from a small group of firms that refurbish the equipment
and offer some sort of short-term guarantee. *Sanatorios* are usually
very small hospitals established by one doctor or a small group of
doctors who often do not have the financial resources to purchase new
equipment. One distributor expressed interest in representing a
well-established U.S. company that offers used medical equipment so that
local consumers can have guarantees and after sales service. The
potential for used medical equipment with local representation is very
good.

Private hospitals are divided into the following categories:

-   Relatively expensive, well established hospitals offering modern
    equipment, nice installations, and specialized medical staff;

-   *Sanatorios*, which are small, privately owned hospitals that do not
    offer the latest installations, equipment, or medical staff, but do
    offer more accessible rates; and

-   Day hospitals where patients stay for only a few hours after a
    surgical or other procedure. Many of the large hospitals now have a
    day hospital.

    Private entities buy significant quantities of disposable medical
    products but their needs are much lower than those of the public
    sector. The larger hospitals have more resources and are able to
    purchase modern equipment from local distributors. *Sanatorios* and
    the like usually purchase used medical equipment.

    Most firms selling into the Guatemalan market do so by means of a
    Guatemalan agent or distributor. However, used equipment dealers
    tend to sell directly to Guatemalan buyers. Generally speaking, the
    more pre-sales marketing and after-sales support and service that a
    product requires, the more important it is to have a local agent or
    distributor.

## Guinea

###### General Market Condition: No Restrictions, but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via Cable), 5 May 2000 {#source-report-from-cs-post-via-cable-5-may-2000 .unnumbered}

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

In Guinea, there are no special restrictions or tariffs that apply to
used equipment that do not apply to new medical equipment. The
importation of used medical equipment is authorized by the Government of
Guinea (GOG).

*Can public health institutions buy used or refurbished medical
devices?*

Public health institutions do not buy used or refurbished medical
devices. The GOG provides these health institutions with new medical
equipment. It is GOG policy not to buy used equipment.

*Is there a market for used or refurbished devices?*

The market for used or refurbished devices is very small. Private
clinics or hospitals are free to purchase used or refurbished equipment
but most of them have very limited resources.

*Best Prospects*?

Private clinics or hospitals are the best prospects since public health
institutions depend on the Government for medical devices.

## Haiti

###### General Market Condition: No Restrictions

### *Source:* International Market Insight, *Regulatory Requirements & Market Prospects For Used Medical Equipment*, 12 March 2002

#### Regulatory Agency

The Haitian Ministry of Public Health and Population supervises the
healthcare sector for the country.

#### Regulations

There are no regulations for the enforcement of quality, technical or
safety standards. The Haitian Government does not restrict the
importation of used/refurbished medical equipment.

#### Standards

Both U.S. and European standards are currently accepted and respected by
the purchasing entities

#### Import Duties and Taxes

Used medical items entering the Haitian customs territory are subject to
the same import tax treatment as new items. Import duties on medical
devices are 16 percent. The tariff system is on a CIF basis. The value
of imported goods, either FOB or CIF, is converted into Haitian gourdes
at the prevailing daily rate, prior to the application of duties and
taxes.

#### Distribution

The market prospects for imports of all types of used/refurbished
medical equipment is relatively strong, since new medical equipment is
considered to be expensive, U.S. companies have a number of options for
entering the Haitian market place, including direct exporting,
franchising, licensing, and wholesaling. The most common method involves
the use of an official representative or distributor, as the Haitian
commercial code does not allow foreigners to engage in wholesale or
retail business without first obtaining a professional license. Most
foreign firms are represented by agents in Port-au-Prince, who then
distribute products to the provinces. The commercial code is designed to
protect Haitian citizens who work as agents and distributors for foreign
companies. The Haitian tax code includes a withholding tax provision,
which, in practical terms, discriminates against foreign investors.
Foreign companies are subject to an additional levy of 30 percent on
profits as a final tax on deemed distributions to foreign shareholders,
whereas local firms are subject to only a 15 percent withholding tax on
distributions. The government has committed itself to removing this
disincentive to invesment; however, further administrative action is
required to implement this commitment.

#### Contact List for Medical Equipment and Health Services Exporters

Ministry of Public Health and Population\
Palais des Ministeres\
Rue Monseigneur Guilloux\
Port-au-Prince, Haiti\
Dr. Henry-Claude Voltaire, Minister\
Ph: (509) 222-2728/222-7020\
Fax: (509) 223-6248

Division D'hygiene Publique\
Direction Centrale de Pharmacie et de Controle\
Des Substances Chimiques\
59 Rue des Miracles\
Port-au-Prince, Haiti\
Mr. Eric Dubosse, Director\
Ph: (509) 223-6826

Association Medicale Haitienne (AMH)\
24 Rue Capois\
Tel: 509) 2238334\
Fax: (509) 223 9885\
Email: amh@haitiworld.com

Hopital de l'Universite d'Etat\
Rue Monseigneur Guilloux\
Centre Ville\
Port-au-Prince\
Telephone: (509) 222 1066/222 4344/223 4261

Hopital Francais\
Rue du Centre\
Port-au-Prince\
Haiti\
Telephone: (509) 222 5966/223 9979/223 9988

Hopital St. Francois de Salles\
Angle Rue Chareron et Rue de l'Enterrement\
Port-au-Prince\
Haiti\
Telephone: (509) 222 5033/222 71 32/222 0232

Hopital du Canape Vert\
Route du Canapé Vert\
Port-au-Prince\
Haiti\
Telephone: (509) 245 0984/245 0985/245 6105\
Fax: 245 0985

Association Medicale Haitienne (AMH)\
24 Rue Capois\
Tel: 509) 223 8334\
Fax: (509) 223 9885\
Email: amh@haitiworld.com

### *Source:* Report from CS Post (via Cable), 10 April 2000 {#source-report-from-cs-post-via-cable-10-april-2000 .unnumbered}

In general, the Haitian government does not restrict the importation of
used/refurbished equipment other than through two regulations, one
governing the imports of used clothing, furniture, bedding, and shoes,
the second governing the importation of used cars (limited to one used
car per person per year). These two regulations are not enforced and
these items are freely imported into Haiti.

All used items, entering the Haitian customs territory are subject to
the same import tax treatment as new items. However. Only one category
of items, used cars pay an additional ten percent (10 percent) CIF.
Tourist tax which does not apply to new cars. Medical equipment, whether
new or used, enter the territory duty free but, like any imported item,
are subject to other import taxes: 4 percent CIF Verification fee, 2
percent CIF. For community management, 2 percent CIF. Account tax, 10
percent value added tax (VAT) on ex-customs value.

Public health institutions as well as private health institutions are
allowed to and in fact import used or refurbished medical devices
therefore indicating the existence of a market for used or refurbished
devices.

## Honduras

###### General Market Condition: No Restrictions, but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via E-Mail), 27 March 2002; updated, 16 April 2003

According to the Honduran Customs and Tax Division, there are no
restrictions or quotas for the importation of remanufactured, rebuilt,
and/or used medical equipment to Honduras. The import tariff for used
medical equipment is the same as that for new equipment. The appraisal
for remanufactured, rebuilt, and/or used medical equipment is carried
out at any port of entry in the country by the customs agent. The import
tax paid for such products is 1 percent of its CIF price.

At present, public health institutions are only allowed to purchase new
medical equipment and supplies through public and international bids.
According to the Ministry of Public Health, the only used medical
equipment acquired has been donated. However, since it is more expensive
to acquire new medical equipment, the Government of Honduras is planning
to modify the current regulation in order to allow the purchase of used
or refurbished equipment (as long as it is accompanied by a warranty of
at least 6 months and servicing/repairs provided locally).

According to industry representatives, there is a good market for used
and refurbished medical equipment, presently reporting 20 percent
increase in demand, especially if after-sales support, repair parts, and
warranty options are available. Approximately 10 percent of medical
equipment imported into Honduras is used or re-conditioned. According to
a report from General Electric (GE), Honduras is the number one importer
of medical equipment in the Central American region, creating an
important market for U.S. medical equipment exporters. For instance,
last year, GE sold magnetic resonance equipment to a local private
hospital in San Pedro Sula, making Honduras the first country in the
Latin American region to import this kind of new and sophisticated
technology in the health sector.

The medical equipment brands of greatest demand in Honduras are: General
Electric, Storz, Medtronic, Ortosintese, Getinge Casde, Wlchallyn, and
Aesculap.

Among the best prospects are X-ray and monitoring equipment, hospital
beds, wheelchairs, uniforms, lab coats, stethoscopes, liftman
stethoscopes, thermometers, breast pumps, scissors, dental care
equipment, digital blood pressure equipment, ophthalmoscopes, eye exam
kits, examination gloves, heart rate monitoring equipment, X-ray view
boxes, blood chemistry and collection equipment, sterilizing equipment,
instrument cleaners, instrument lubricants, ultrasonic cleaners, rapid
diagnostic test kits, and surgery and intensive-care equipment.

For additional information on the market for used and refurbished
medical equipment in Honduras, please contact Elizabeth Danforth at the
Commercial Service Office in Tegucigalpa, Honduras, tel. (504) 238-5114,
fax (504) 238-2888.

## Hong Kong

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 13 March 2002 {#source-report-from-cs-post-via-e-mail-13-march-2002 .unnumbered}

In Hong Kong, there are no special restrictions or tariffs that apply to
used medical equipment that do not apply to new medical equipment. Hong
Kong agents and distributors in this industry prefer to source the
'newest and latest' equipment. There is limited market for used and
refurbished medical equipment. Public hospitals, private hospitals and
health institutes in Hong Kong do not buy used medical devices. There is
very little business opportunity for used/refurbished medical equipment
in China due to government restrictions.

## Hungary

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 26 March 2002

*Are there special restrictions or tariffs that apply to used medical
equipment?*

No, there are no special restrictions/tariffs that apply to used medical
equipment, that apply to new medical equipment.

*Can public health institutions buy used or refurbished medical devise?*

Yes, public health institutions can buy used medical devices.

*Is there a market for used or refurbished medical devices?*

The market is very limited for used/refurbished medical devices. Most of
the healthcare institutions are state-owned and 'are not interested in
saving on equipment purchases.' Right now clinics prefer to wait until
they have enough money for a new device instead of 'saving on time and
money' by purchasing used or refurbished equipment. There has not been a
tradition of buying used equipment in Hungary and people seem reluctant
to buy pre-owned devices. Hungarians do not consider purchasing
refurbished medical equipment as a real option.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

There are only ad-hoc purchases of pre-owned equipment.

### *Source:* Industry Sector Analysis, Medical Equipment, 15 February 2002

Leasing of medical equipment has no tradition in Hungary and is in its
very early stages. The market for used/refurbished medical equipment has
also been very limited in Hungary. However, with increasing
privatization opportunities, their sales prospects might improve.

### *Source:* Report from CS Post (via E-Mail), 26 March 2001

In Hungary the use of used/refurbished medical equipment is rather
limited. The reason might be the regulation below, or simply little
tradition so far.

In response to an inquire with the Authority for Medical Devices in the
Hungarian Ministry of Health, he Deputy Director advised as follows:
'there are no special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment. Public Health
institutions can buy used/refurbished medical devices. The general rule,
that applies to all medical equipment and devices (whether imported or
locally manufactured) is a Ministry Decree of 1998 (21/1998/VI.3), Annex
17. This annex lists all medical equipment/devices with the 'approved /
authorized length of life,' it actually tells/prescribes to all medical
institutions how long they can use their equipment. In practice, as the
Hungarian health care system lacks funding, the Ministry does not
'check' how old the equipment are, as the government-owned
hospitals/clinics could hardly afford to buy new equipment. However if a
clinic would want to buy a piece of used equipment, the Authority for
Medical Devices would register/check how old the equipment
to-be-imported is, and would tell the clinic for how many more years it
could use the equipment.'

## Iceland

###### General Market Condition: No Restrictions, but CE Mark is Required

### *Source:* Report from CS Post (via E-Mail), 4 March 2002

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No, there are no special restrictions or tariffs that apply to used
medical equipment. The same rule applies to both new and used medical
equipment. However, as in most European countries, Iceland requires the
CE mark on all medical equipment, used or new.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, they are allowed to buy used or refurbished medical equipment but
so far no interest has been shown to do so, simply because health
institutions prefer to purchase new equipment.

*Is there a market for used or refurbished medical devices?*

According to the Icelandic Ministry of Health there has not been a
market for used or refurbished medical equipment, since institutions
prefer to purchase new equipment.

*If there is a market, what types of used or refurbished medical
equipment are in greatest demand?*

Not applicable.

## India

###### General Market Condition: Restricted

### *Source:* Industry Sector Analysis, *Cancer Diagnostic and Treatment Equipment*, 28 April 2001

End-users are becoming increasingly aware of the state-of-the-art Cancer
Diagnostic and Treatment Equipment (CD&TE) equipment available in the
world market. Most of India's leading cancer specialists attend medical
conferences in the United States and Europe to keep abreast of the
latest technologies. Price, product features and payment terms are key
factors which influence purchase decisions of hospital administrators.
Charitable organizations and rural hospitals unable to afford the
latest, new equipment often purchase used or reconditioned equipment
imported from abroad.

Used medical equipment also has market potential in the country. The
present GOI's current Export-Import policy allows imports of used
equipment including used CD&TE equipment. Used equipment including CD&TE
equipment that is less than 10 years old can be imported into the
country. The importer should not sell, transfer or otherwise dispose of
this equipment within a period of two years from the date of import. The
Director General of Foreign Trade, New Delhi, will grant a waiver to
this requirement. Price-sensitive Indian end-users prefer to buy
refurbished medical equipment including cancer treatment equipment for
some low-end applications. However, these buyers look forward to
continued support for spare parts and service commitments.

### *Source:* Report from U.S. Commercial Service, November 2000 {#source-report-from-u.s.-commercial-service-november-2000 .unnumbered}

In July 2000, India's Directorate General of Foreign Trade (DGFT),
Ministry of Commerce, issued a policy circular detailing guidelines for
importing second-hand capital goods, including medical equipment. The
policy incorporates changes to paragraph 5.3 of the Export Import Policy
of 1997-2002 and paragraphs 5.29 and 5.30 of the handbook of procedures.
As per the provisions contained therein, import of second-hand capital
goods is restricted and subject to import licensing procedures.

Applications for such licenses are considered by the inter-ministerial
Restricted Items Licensing Committee under the DGFT, New Delhi. The
Committee will consider such applications according to the following
guidelines:

-   Capital goods not older than 5 years: The committee will normally
    allow imports of such capital goods automatically.

-   Capital goods older than five years but less than ten years old: The
    committee will take into consideration the comparative
    advantages/benefits of such imports vis-à-vis new capital goods.

-   Capital goods older than 10 years: Imports of such capital goods
    normally will not be allowed except for heavy equipment in the
    infrastructure and core sectors.

The imported capital goods will have to conform to acceptable
environmental and industrial safety norms. Apart from the criteria
mentioned above, the committee might establish any other criteria, as it
may deem necessary.

### *Source:* IMI, 9 December 1999

Under immense pressure from the domestic industry the Indian Government
has eased the imports of second-hand machinery. The Government of India
will now allow second hand capital goods imported into the country under
the special import license route. An importer has to purchase the
special import license from the open market at a premium and can import
the second hand machinery, which is less than five-years-old. For
machinery more than five-years-old the current procedure for imports
will apply. It will not be possible for importing capital goods more
than ten years old. A notification to this effect is being prepared by
the Indian government.

Ministry officials said applications for import of second-hand machinery
more than five years old will be placed before special licensing
committees in the same manner as application for import of other
restricted items.

When the new export import policy was announced in March 1999, several
industry associations had complained that import of used equipment must
be made easier so that the Indian industry can acquire the latest
equipment and compete globally. This new announcement is in keeping with
the demand from the user industry and the chamber of commerce
representations.

Capital goods account for 25 percent of total imports and 75-80 percent
of the capital goods imported into India was used machinery and
equipment. Such a large percentage of imports will now be able to bring
in latest equipment. This will also facilitate the import of used
equipment by small-scale sector, which cannot afford new capital
equipment.

### *Source:* ISA Medical, 31 March 1999 {#source-isa-medical-31-march-1999 .unnumbered}

#### Best Prospects {#best-prospects .unnumbered}

Refurbished medical laboratory instruments also find a ready market in
India. These instruments are used as back-up machines in top-of-the-line
hospitals. Less sophisticated hospitals and district hospitals view
refurbished medical laboratory instruments as optimal for their
laboratories because the investment cost is substantially lower than for
new instruments. Some international companies operating in India also
sell used medical laboratory instrument to their Indian customers. Also,
Indian hospitals and agents demand continuous service support for these
instruments and require spares when needed. U.S. Companies in the
used/refurbished medical instruments business may consider setting up
liaison offices in India to promote their products.

### *Source:* IMI, 16 July 1998 {#source-imi-16-july-1998 .unnumbered}

There are several restrictions on the import of used equipment in India,
prescribed by India's import-export policy, in force from 1997 to 2002.
Second-hand capital goods with a minimum residual life of 5 years can be
imported by actual users of such equipment without a license. The
importer is required to furnish a self-declaration to the customs
department specifying the residual life of the second-hand capital goods
in a prescribed format.

The importer is also required to furnish a certificate from an
internationally reputed inspection and certification agency that the
purchase price of the equipment is reasonable. This certificate is
required at the time of clearing the goods through customs, where the
CIF value of the goods exceeds Indian rupees 10 million (US\$ 238,000).
Where the second-hand equipment has a CIF value of up to RS. 1 million
(US\$ 23,800), customs authorities will not insist upon such a
certificate.

The second hand equipment shall not be transferred, sold or otherwise
disposed of within a period of 5 years from the date of import, except
with prior permission of the director general of Foreign Trade. While
selling, U.S. firms should remember that valuation of used or
second-hand equipment is a very technical area with frequent disputes
between customs and the importer. For problems, U.S. exporters can
contact:

Mr. L.N. Lakhan Pal, Director General of Foreign Trade\
Ministry of Commerce Government of India\
Udyog Bhavan, Maulana Azad Road\
New Delhi 110001, India\
Tel: 91-11-301-1777 Fax:91-11-301-1779

Spares, including accessories and tools for the maintenance and
operation of such equipment, can be imported to the extent of 15 percent
of the value of the equipment.

India is a high-cost economy for capital equipment, and Indian
manufacturers and investors constantly seek to reduce their capital
costs. For this reason, demand for used and reconditioned equipment is
high across a range of industry sectors. The best opportunities for U.S.
firms to pursue are in the industry sectors of construction, mining,
medical, machine tools, plastics, steel, oil refining, computers,
printing, packaging and dairy equipment.

While rates of customs duty vary from product to product, they are,
generally speaking, lower for used equipment as compared with new
equipment.

## Indonesia

###### General Market Condition: No Restrictions, but Public Institutions Cannot Purchase

### *Source:* IMI Medical, 18 February 2000 {#source-imi-medical-18-february-2000 .unnumbered}

The Ministry of Health prohibits public hospitals from using used or
refurbished medical equipment, however, this prohibition does not apply
to private hospitals. Given the poor economic condition in Indonesia,
the purchase of new medical equipment is no longer affordable for most
hospitals. The situation has compelled private hospitals to seek
alternative medical products at an affordable price.

Indonesian medical suppliers discovered that since 1999, the request for
used/refurbished medical equipment has increased. This is because
hospitals need to replace the old equipment, which was mostly purchased
before the economic crisis. According to the medical suppliers, the
purchases for used/refurbished equipment are still very low, however,
they anticipate the demand will gradually increase in the future.

To protect their image, medical equipment suppliers refused to sell both
new and used equipment, although they would do it on a case by case
basis upon order. Hospitals were unwilling to buy used/refurbished
medical equipment because they claimed that they did not get good
service from the manufacturer, spare parts were hard to replace, and
after sales service was poor. To take the greatest advantage of export
opportunities, used/refurbished equipment suppliers should be able to
provide training, technical assistance, spare parts, and after sales
service.

The import tariff for medical equipment for both used and new ranges
from 5 to 10 percent with a value-added tax of 10 percent.

### *Source:* Report from CS Post (via Cable), 22 February 2000 {#source-report-from-cs-post-via-cable-22-february-2000 .unnumbered}

The Ministry of Health (MOH) prohibits public hospitals from using used
or refurbished medical equipment but there is no written regulation on
this.

Private hospitals are not bound to the above policy. Imports of used or
refurbished equipment had not been very significant in the past. Because
of low purchasing power, private hospitals are beginning to show
interest in used or refurbished medical equipment.

Local medical suppliers anticipate that the demand for used or
refurbished medical equipment will gradually increase in the future.

The import tariff for both used and new medical equipment ranges from 5
to 10 percent. It is subject to a value-added tax (VAT) of 10 Percent.

## Israel

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 14 April 2003

#### Summary

The Israeli market for used medical equipment is very small and
considered insignificant for US exports. There is no special tariff that
applies, and the official import requirements are the same as for new
equipment. However, in practice, the Ministry of Health (MOH) permits
the import of used/refurbished equipment only by specific end-users, and
does not issue registration certificates for imported used equipment.

#### The Registration Process

By law, all medical equipment used in public health institutions
requires MOH Registration. MOH registration provides the health
institution legal protection in the event of mal-function of the device.
Hospitals and other health institutions may import or receive donated
equipment if it is for their own use only. However, they will not
receive the MOH "blessing" and they will operate the equipment at their
own risk. MOH does not approve imports of used/refurbished equipment by
commercial agencies/distributors for resell in the market.

#### Import Requirements

In order to release used medical equipment from customs, MOH requires
the end-user to report in details the complete history of the device: by
whom, for how long, and where the equipment was used and / or
refurbished and where it was tested to comply with technical standards.
The end-user must declare that the used equipment is for its own use and
provide a proof of available chain of supply (of spare parts) from the
original manufacturer.

#### Parallel Imports

If a manufacturer or its agent registered a medical device in Israel, a
third party cannot relay on this registration to import the same device
in used/refurbished condition without being subject to the above import
requirements. The same applies to parallel imports of new equipment.

#### Type of Used/Refurbished Equipment already in the Market

Existing used or refurbished equipment in local hospitals include
ultra-sound and laser.

#### Contact Information

Embassy contact:

Mrs. Yael Torres\
Commercial Specialist\
US Embassy in Israel\
E-mail: yael.torres@mail.doc.gov\
Tel: 972-3-5197611\
Fax: 972-3-5107215\
Web Site: www.BuyUSA.gov/israel

Government of Israel Contacts

Ministry of Health\
Medical Technologies & Infrastructure Administration\
Medical Device Department\
P.O. Box 1176\
Jerusalem, Israel 91010\
Contact Person: Ms. Elona Bitnun, Coordinator\
Phone: 972-2-5681354, 972-2-5681216\
Fax: 972-2-6725827\
E-Mail: elona.bitnun@moh.health.gov.il

Ministry of Health\
Medical Technologies & Infrastructure Administration\
Medical Device Department, Tel Aviv Branch\
Sheba Medical Center, Bldg. 130\
Tel Hashomer, Israel 52621\
Contact Person: Mr. Nadav Sheffer, Acting Director\
Phone: 972-3-5303291\
Fax: 972-3-5344552\
E-Mail: sheffer@eng.tau.ac.il

## Italy

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 22 march 2002

There are no restrictions or special tariffs on imports of used and
refurbished medical equipment into Italy. However, the CE mark is
required for all used or refurbished medical equipment and devices, and
the same safety standards apply for new and used alike.

Though there are no impediments to the purchase of used and refurbished
medical equipment, but the prevailing practice in public hospitals and
medical facilities is to purchase new equipment because of liability
issues. Public hospitals are forced to comply with current regulatory
issues, which mandate that all equipment and devices utilized in public
healthcare facilities has to be in accordance with CE mark regulations,
in effect from June 1998, by Directive 93/42/EC. The public healthcare
service accounts for over 75 percent of expenditures for medical
equipment.

The Italian market for used medical equipment is very small and is
mostly confined to the private sector. The majority of used medical
equipment now available has been on the market prior to the directive,
and in most cases does not have the CE Mark, nor does it meet the
stringent safety parameters. The process of refurbishing medical
equipment to the point of meeting the requirements of the directives and
to acquire the CE Mark is very costly and, once completed, makes the
selling price of pre-owned equipment prohibitively expensive.
Consequently, savings are not enough to justify the purchase of used
equipment. To be appealing, the price of used and refurbished medical
equipment should be approximately 40 percent less than the selling price
of new equipment. Sales of refurbished medical equipment must be
supported by pre- and post-sale marketing and technical assistance.

A niche market exists for used and refurbished medical equipment that
can be sold to small, privately owned healthcare facilities--- which due
to their size and specialization are exempted from fully complying with
the existing regulations---and to private practitioners. Thus, the best
selling used medical products are diagnostic imaging equipment, EKG,
monitoring equipment, ultrasonic equipment, ophthalmology equipment,
dental chairs and dental equipment, and apparatus and equipment for
physical therapy and rehabilitation.

## Jamaica

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 3 May 2000 {#source-report-from-cs-post-via-e-mail-3-may-2000-1 .unnumbered}

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

None of which the Post is aware, but all imported equipment should
ideally be approved by the Jamaica Bureau of Standards.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, but again subject to the conditions above. All of last year, Y2K
was a big thing. Health services were announcing that they would only be
buying items that were Y2K compliant.

*Is there a market for used or refurbished devices?*

In theory there should be, but new items are greatly preferred.

*Best prospects?*

Unknown.

## Japan

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 26 March 2002. Information re-confirmed by CS Post, 17 April 2003. 

*Are there special restrictions or tariffs that apply to used medical
equipment?*

All imports of used equipment are treated the same as new, and thus each
product must obtain MHW (Ministry of Health and Welfare) approval for
import.

Although there is no tariffs levied on medical devices, this area is
highly regulated by the Pharmaceutical Affairs Law of the Ministry of
Health, Labor and Welfare (MHLW). In order to market a foreign medical
product in Japan, an importer must obtain "manufacturing approval"
(*shonin*) for safety and efficacy of a medical product. In order to
handle a shonin-approved product, an importer or a seller needs to
obtain "*kyoka*" license based on its facility, personnel and
qualification of a technical director. A foreign manufacture may obtain
the *shonin* approval by using an in-country care taker (ICC). If a
foreign manufacturer receives a *shonin* approval, an importer is not
required to obtain a shonin approval for such items.

In many cases, a Japanese importer receives "manufacturing approval"
(*shonin*). It means that an importer who has a *shonin* approval will
have a full control. If a different importer wishes to sell the same
product (either used or new), this importer must receive a product
approval from the Ministry. If a U.S. manufacturer holds an approval,
they can sell their product through multiple distributors that have
"*kyoka*" license to sell medical devices in Japan. A Japanese doctor
can import a medical device to treat his/her patients at his/her risk.
However, in this case, no reimbursement is given for those treatments,
and thus direct import from Japanese general clinics and hospitals is
very limited. Japanese beauty clinicians and veterinarians often import
new and used medical device as their treatments have no reimbursement
coverage in Japan's system.

*Can public health institutions buy used or refurbished medical devise?*

Although there is no statistical information available, used/refurbished
medical equipment is becoming more attractive to medical institutions,
including public hospitals, because of cost factors. This trend may
continue coming years as the financial status of many Japanese hospitals
is also becoming more precarious. Over 70 percent of Japanese hospitals
are believed to be operating in deficit and the number of hospitals
declaring bankruptcy is increasing. More efficient use of
used/refurbished medical equipment may be needed to meet these growing
financial challenges.

*Is there a market for used or refurbished medical devices?*

The sale of such equipment in Japan is a more viable option for local
manufacturers and re-sellers than for third-party exporters. Industry
sources indicated that market demand for such equipment is particularly
strong for ultrasonic diagnostic equipment, X-ray equipment, clinical
examination/laboratory equipment, etc.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

The Japan Federation of Medical Devices Associations (JFMDA) has
prepared a guide on the handling of second-hand medical devices with the
objective of establishing a closer network system between manufacturers
and medical facilities and to ensure the safer and more effective use of
these devices.

## Jordan

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 28 June 1998 {#source-report-from-cs-post-via-cable-28-june-1998 .unnumbered}

Equipment is assessed the tariff that applies to its Harmonized Tariff
Schedule (HTS) category, regardless of whether it is new or used. The
base value of used equipment, however, is depreciated according to the
judgment of the customs inspector. Therefore, the net customs levy on
used equipment may be lower or even higher than on new equipment,
depending on the customs inspector.

No customs duties apply to new or used industrial equipment if it used
for production.

## Kazakhstan

###### General Market Condition: No Restrictions

### *Source:* IMI 26, August 1998 {#source-imi-26-august-1998 .unnumbered}

Kazakhstan does not have any special regulations for the importation of
used/refurbished equipment. This type of equipment can be imported in
accordance with regular customs import requirements. Licenses and
certificates of conformity may be required for the import of certain
types of equipment.

Kazakhstani customs does not distinguish between new and used equipment
when being declared for customs clearance. Used equipment is released
subject to completion of the customs clearance process which is same as
for new equipment. There are no special duties for the importation of
used equipment in Kazakhstan.

Licenses are required to import equipment that may affect the health of
citizens, the environment, or national security. These types of
equipment are subject to mandatory safety certification.

The best industry sectors for the export of certain types of
used/refurbished equipment to Kazakhstan are: automotive, oil and gas,
power generation, medical, agriculture, and food processing. Subject to
the availability of warranties and spare parts, cheap used medical,
agricultural, and food processing equipment is believed to have better
marketability versus expensive new equipment.

## Kenya

###### General Market Conditions: No Restrictions

### Source: ISA Electro-Medical Equipment Market, 29 April 2003

#### Competitive Analysis

Key competitive factors that serve to limit the potential for the sale
of U.S. electro-medical equipment include price, promotion and
after-sales service. Many of the industry stakeholders identified
promotion as a major limitation that resulted in their lack of knowledge
and awareness of medical technologies from the United States. Unlike the
U.K, German and Dutch medical equipment suppliers who have over the
years actively promoted their products to the Kenyan market, only a few
U.S. suppliers such as G.E. Medical systems were identified but still
accused of not being as active as their European counterparts.

Secondary to promotion is the issue of after-sales service backup. Many
of the health institutions that had purchased U.S. medical equipment
cited poor after-sales service as a major problem. The lack of locally
available spares and parts was attributed to the absence of local
representative offices for the U.S. companies. It is recommended that
U.S. companies consider appointing local agents or representatives to
facilitate this after-sales service component that could also be used to
promote U.S. medical equipment technology. This is the path, which
successful European suppliers have chosen. Aggressive promotion
campaigns can only be successful if they are not limited by the lack of
a perpetual presence in any market of interest.

Considering the dynamism of medical science, a number of Kenyan health
institutions would like U.S. medical equipment suppliers to consider the
sale of used and refurbished equipment as well as leasing options for
new upgradeable equipment as enviable marketing strategy.

#### Import Climate

Medical equipment imports into Kenya require an import license, as is
the case with all other health sector inputs. The import climate for
U.S. medical equipment market in Kenya is good. There are no import
barriers, and the customs duty range from 0% to 15%.

The following documentation is required to facilitate importation of
medical equipment:

Import declaration form (IDF) Commercial invoice Airway bill
(airfreight) or bill of lading (sea freight) Pre-shipment inspection
Clean Report of Findings (CRF).

Imports with a Free on Board (FOB) value over U.S\$ 5,000 are subject to
a pre-shipment inspection, at the port of shipment. Pre-shipment
inspection can be done by one of the two appointed supervision services
companies, namely Cotecna Inspection SA and Intertek Testing Services
(ITS) International. The cost of pre-shipment inspection is 2.75% of the
cumulative cost, insurance and freight (C.I.F) value, payable as an
import declaration form (IDF) processing fee. If not indicated, freight
is calculated at 18.5% of the consignment cost, and insurance 1.5% of
the sum of the consignment cost and freight.

Medical equipment is generally exempt from both import duties and value
added tax (VAT). Exceptions include microscopes and dental chairs, which
attract 5% duty and liquid-filled clinical thermometers that attract 15%
import duty and 18% VAT.

No approval is required to import any kind of irradiating device.
However, prior to installation of any irradiating device the Radiation
Protection Board must conduct an inspection and thereafter grant a
license. There is no ban on the import of any type of pre-owned (used
and refurbished) medical equipment to Kenya so long as the performance
characteristics conform to the existing national standards and where
none exist, reference is made to the International Organization
Standards (ISO).

The trademark name and country of origin must be displayed in English
and/or Kiswahili for all categories of medical equipment. In addition,
an expiry date must be shown for all medical consumables.

## Korea, South

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 18 April 2003.

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No. However, each unit of imported used medical equipment is subject to
testing in medical device testing facilities approved by the ROKG.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc?*

When a third party legally imports used/refurbished medical devices
(which have been previously imported as newly-manufactured products by a
registered import agent), these used/refurbished medical devices are
subject to the same kind of inspection and certification process as are
the new products. The Korean regulatory agency, Korea Food & Drug
Administration (KFDA), requires an equal amount and degree of product
information for approvals for both new and used products. In practice,
each used/refurbished piece of equipment is treated as a separate,
re-manufactured product. As part of the process, the importer of
used/refurbished equipment must submit a certificate to foreign
government (CFG), which is issued by the U.S. FDA, as well as extensive
technical information on the products.

*Can public health institutions buy used or refurbished medical
devices?*

\[See below for discussion in report submitted in 2002\].

*Is there a market for used or refurbished medical devices?*

\[See below for discussion in report submitted in 2002\].

*If there is a market, what types of used or refurbished medical
equipment are in the great demand?*

Best prospects for the used medical equipment include clinical chemistry
analyzers, Immunofluorometer equipment, and CTs.

#### Statistics

Official 2002 Korean statistics for used medical equipment will not be
available until May 2003. Below are unofficial estimates for major
categories of used medical equipment from the Korea Medical Devices
Industry Association (KMDIA).

Korea: Import Statistics for Major Used Medical Equipment\
2002

  ------------------------------- ------------------- -------------------
                                  Unit                Price (US\$)

  Flow-type clinical chemistry    42                  537,816
  analyzer                                            

  Immunofluorometer equipment     8                   385,024

  Computed Tomography (CT)        7                   203,351

  Tracheal tube &\                1\                  33,762
  catheter                        150                 

  Angiographic X-Ray              1                   21,171

  Ultrasonic imaging diagnostic   1                   19,000
  equipment                                           

  Total                           1,209               1,200,124
  ------------------------------- ------------------- -------------------

> Source: Korea Medical Devices Industry Association (KMDIA)

### *Source:* Report from CS Post (via E-Mail), 29 March 2002

#### Summary

There is a small, but growing demand in Korea for used/refurbished
medical products, particularly for the latest models of internationally
recognized premium brands of radiography equipment. Market demand is
strongest for used computer tomography(CT), magnetic resonance imaging
(MRI) equipment, X-ray mammography equipment, and premium quality
ultrasound scanners. Although the Korean government implemented major
regulatory changes to open the market for imports of used/refurbished
medical equipment in 1997, such imports are still encumbered by
requirements for extensive technical information and U.S. FDA
certificates for local pre-market approvals. Thus, the sale of such
equipment in Korea is more of a viable option for manufacturers than for
third-party exporters. Under current regulations, the realization of
this growing market potential is heavily dependent on the ability of
U.S. exporters to provide such information for their Korean distributors
to obtain necessary approvals.

#### Market overview 

Prior to July 1997, the Korean government prohibited the importation of
used/refurbished medical equipment. Since the ban was lifted through
regulatory changes, the market demand has grown significantly and
primarily for expensive radiography equipment. A growing demand has
emerged for a few types of used capital goods for medical institutions,
including Computer Tomography (CT) equipment, magnetic resonance imaging
(MRI) equipment, mammography X-ray equipment, premium quality ultrasound
scanners, and diagnostic biochemical analyzers. There is also a strong
demand for laser printers used for diagnostic X-ray imaging equipment.
In particular, local end-users are mostly interested in recent models of
internationally renowned premium brands that would otherwise very
expensive, if purchased new. In terms of numbers of units, the strongest
market demand has been for blood analyzers, diagnostic X-ray equipment
and ct equipment. The market demand for diagnostic blood analyzers
increased from 19 units in 1998 to 84 units in 1999 but dipped to 63
units in 2000. The demand for computer tomography equipment steadily
increased from 45 units in 1998 to 103 units in 1999 to 114 in 2000. In
1998, 15 units of diagnostic X-ray equipment were sold in Korea; that
number increased to 44 units in 2000.

Commercial Service (CS) Korea will update the table below on import
statistics after the Korean Government publishes its 2001 statistics in
April 2002. Import statistics from 1998 to 2000 for some of the
used/refurbished medical equipment that have been in greatest demand are
listed below.

Import Statisics for Selected Categories of Used/Refurbished Medical
Equipment\
1998--20000

  -------------------------- --------------- ------------ ----------------
                             1998            1999         2000

  Diagnostic X-Ray           15 units        14 units     44 units

  CT                         45 units        103 units    114 units

  MRI                        4 units         12 units     13 units

  Diagnostic Blood Analyzer  19 units        84 units     63 units

  Surgical Laser             ---             11 units     14 units
  -------------------------- --------------- ------------ ----------------

According to local industry sources, imports of used medical equipment
in 2001, including Computer Tomography (CT) and Magnetic resonance
Imaging (MRI), decreased for the first time since 1997. Below are
unofficial import statistics from Korea Test Laboratories (KTL) for
major categories of used medical equipment. KTL is an independent
medical device testing facility approved by the ROKG.

Import Statistics of Major Used Medical Equipment

  ------------------ -------- ------- -------- -------- -------- ---------
                     1997     1998    1999     2000     2001     Total

  CT                 21 units 38      101      114      41 units 315 units
                              units   units    units             

  MRI                ---      2 units 12 units 9 units  5 units  28 units

  Mammography X-Ray  ---      ---     ---      ---      22 units 22 units

  Surgical Laser     ---      ---     7 units  11 units 17 units 35 units

  Others             6 units  5 units 14 units 35 units 59 units 119 units

  Total              27 units 45      134      169      144      519 units
                              units   units    units    units    
  ------------------ -------- ------- -------- -------- -------- ---------

Source: Korea Test Laboratories

Despite Koreans' strong disposition against used products in general,
the market demand initially emerged in the midst of the country's
economic crisis, which erupted in late 1997. Although Korea is
recovering from the overall economic crisis, a new crisis, the near
bankruptcy of the national healthcare system, has begun to put severe
cost-containment pressure on the market demand for all types of medical
equipment. Additionally, the dramatic depreciation of the Korean won has
precluded many health institutions' ability to purchase expensive,
imported equipment in the price range of a few hundred thousand dollars
to a million dollars. All of these factors are causing Korean hospitals
to seek alternatives to the latest models of highly expensive equipment
and to opt for used/refurbished equipment that incorporates the best
technologies at considerably reduced prices.

#### Major players

The major players active in the re-marketing sector of used/refurbished
medical equipment are the same as those active in marketing new products
of the same brands. For example, large multinational radiography
equipment suppliers, such as General Electric, Toshiba and Hitachi and
Philips have all begun to implement re-marketing programs for their
proprietary brands. Foreign manufacturers re-market used/refurbished
products either through their Korean subsidiaries or through their
Korean distributors. Imports of used/refurbished equipment sourced from
third-party re-marketers are very few in number, primarily as a result
of regulatory requirements for product approvals and the advantage that
manufacturers' distributors enjoy in terms of product knowledge and
after-sales service.

#### Future prospects and competitive elements

There is a strong consensus among industry experts that the market
demand for used equipment will continue to increase over the next
several years. With Korea's healthcare system experiencing a financial
crisis, the pressure for cost-containment is expected to remain high,
and local healthcare institutions will continue to seek inexpensive
alternatives for capital medical equipment.

Although competitive pricing is a critical competitive factor, Korean
health care institutions are also very concerned about the quality of
used/refurbished equipment. They expect to be offered comprehensive
warranties and to work with a trustworthy, technically qualified
distributor who can provide competent after-sales service.

The full realization of this high market potential, however, will have
to rely heavily on the ability of foreign exporters to provide together
extensive technical information and U.S. FDA certificates for pre-market
approvals, as described below.

#### Regulatory Environment

There are no special restrictions or tariffs that apply to used medical
equipment that do not also apply to new medical equipment. Just as new
products are subject to pre-market approvals, so are imports of
used/refurbished equipment. Since an approval for a product is granted
to a locally-based firm, the full process of review for approval must be
repeated for the same product each time a different local firm imports
the product.

The Korean regulatory agency, Korea Food & Drug administration (KDFA),
requires an equal amount and degree of product information for approvals
for both new and used products. In practice, each used/refurbished piece
of equipment is treated as a separate, re-manufactured product. As part
of the process, the importer of used/refurbished equipment must submit a
certificate to foreign government (CFG), which is issued by the U.S.
FDA, as well as extensive technical information on the product. Most
Korean distributors are aware from their experiences in working with
U.S. third-party exporters that the CFG is usually available only from
the U.S. manufacturer. Therefore, it is very difficult for the Korean
importer who does not have a direct business relationship with the U.S.
manufacturer to provide the necessary documents for approval. As a
result, Korean importers of used/refurbished equipment are either local
subsidiaries of the manufacturers or authorized distributors for new
products of the same brands.

Korean regulations mandate additional testing requirements for used
medical devices. Each piece of used/refurbished equipment must be tested
by a KDFA-authorized lab not only as part of the pre-market approval
process but also throughout the post-approval marketing period. (In
contrast, newly manufactured equipment is required for testing by a
authorized-authorized lab only for pre-market approvals.) Nonetheless,
Korean importers do not view this approval process as a major import
barrier since testing is normally straightforward and fees are
reasonable.

In order to encourage small hospitals to share expensive equipment,
regulations require hospitals to receive prior approval from the
Ministry of Health and Welfare (MHW) for purchases of equipment costing
over US\$ 500,000. Under the present system, only hospitals that
specialize in radiology, have 200 beds or more, and have on-staff at
least one physician specializing in diagnostic radiology can own MRI
equipment. General hospitals must have 70 beds or more in their own
facilities with an additional 130 beds or more in other facilities in
order to share an MRI.

#### Used/refurbished equipment purchases by public institutions

There are no special regulations prohibiting public hospitals from
purchasing pre-owned equipment. However, public hospitals do not appear
to consider purchasing used/refurbished equipment as a viable option
since as non-profit organizations, there is no internal incentive to
control operational costs. Another factor is the long cycle involved in
obtaining budget appropriation approvals from funding authorities. Since
the availability of supply of used/refurbished equipment is not known
far in advance, public hospitals prefer to work with predictable cost
factors and, therefore, to purchase new equipment, regardless of cost.

## Kuwait

###### General Market Condition: Prohibited

### *Source:* Report from CS Post (via Cable), 29 April 2002

Kuwait\'s public health institutions do not buy used/refurbished medial
devices. All tenders call for new devices and equipment. The public
health sector represents about 90 percent of the total market, with the
remaining 10 percent for the private sector. The latter does not buy
used devices. Tariffs are imposed on new equipment only (currently at 4
percent of value); it will be increased to 5 percent in 2003. Used
equipment will not be permitted to be imported. Used/refurbished
equipment does not have a market in Kuwait.

### *Source:* Report from CS Post (via Cable), 19 October 1998 (Information confirmed 18 March 2001) {#source-report-from-cs-post-via-cable-19-october-1998-information-confirmed-18-march-2001 .unnumbered}

The export market for used equipment in Kuwait is extremely limited. As
a policy, the Government of Kuwait will not purchase used equipment for
use in any of its ministries or para-statal companies. Since these two
categories account for approximately 90 percent of the economy, the
limited potential is readily apparent.

In addition, outright prohibitions exist in Kuwait against the
importation of the following:

-   Used medical equipment and instruments.

-   Used vehicles manufactured prior to five years from the date of
    importation.

-   Used clothes and other items of personal wear.

## Kyrgyzstan

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 7 August 1998

The Kyrgyz Republic has the following regulations for importation of
used/refurbished equipment:

A. Currently, there are no restrictions on the imports of used equipment
to Kyrgyzstan. All equipment, whether used or new, imported into the
country is treated the same way;

B. However, if a company intends to import used/refurbished equipment,
it is strongly recommended to specify this in agreements and other
documents;

C. According to Kyrgyzstani experts, the used/refurbished equipment can
be used almost in all industries, first of all in such branches as
electric power, electro-technical, light and food industries as well as
agriculture. Unfortunately, the National Statistical Committee does not
track the market for the equipment in question.

## Liberia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 2 March 2002 {#source-report-from-cs-post-via-cable-2-march-2002-2 .unnumbered}

#### Overview

Liberia does not have restrictions on the importation of used or
refurbished medical equipment. There are no specific laws that govern
the importation of used or refurbished medical equipment. Neither
government nor private health institutions are discouraged from
importing or purchasing used medical equipment. However, the Ministry of
Health must certify drugs and other medical expendibles that are
imported into the country.

Used medical equipment is not treated or handled differently from new
equipment with regards to custom and tariffs.

Most of the medical equipment used in Liberia at the moment is not of
high technology. According to sources at the Ministry of Health in
Monrovia, most medical equipment used in government hospitals is used or
refurbished, donated by NGOs from the United States and Taiwan.

Private health institutions are the biggest importers and users of used
and refurbished medical equipment and statistics indicate that they will
remain so for the next couple of years, as most government health
institutions remain closed or in derelict state.

The major types of used or refurbished medical equipment in greatest
demand in both public and private health institutions include laboratory
equipment, hospital beds and furniture, X-ray equipment, scanners,
surgical equipment, cardiac monitors and printers, baby incubators,
pediatric weight scales, iv poles, transfusion pumps, and
phaco-emulsifier machines.

#### Responses to Specific Questions

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no special restrictions or tariffs that apply to used or new
medical equipment. Neither used nor new medical equipment have special
restrictions or tariffs that favor one over the other.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, public health institutions can buy used or refurbished medical
devices.

*Is there a market for used or refurbished devices?*

Yes. As a matter of fact, used or refurbished medical equipment are
imported or bought more often than new ones, primarily because of
economic reasons.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Used or refurbished medical equipment in greatest demand include
laboratory equipment, hospital beds and furniture, x-ray, scanners,
surgical equipment, cardiac monitors and printers, baby incubators,
pediatric weight scale, i.v poles and transfusion pumps and
phaco-emulsifier machines.

#### Sources

Mrs. Sodey Lake, Administrator, Tubman National Institute of Medical
Arts (Tnima)\
Amelia Ayomanor Nursing Administrator, John F. Kennedy Medical Center\
Ministry of Health, Information Section\
Ndu L.Adighibe, Assistant Minister of Commerce for Foreign Trade

## Luxembourg

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also the entry for the European Community.*

### *Source:* Report from CS Post (via E-Mail), 15 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment?*

There are no restrictions in Luxembourg that apply to used medical
equipment other than EU restrictions that apply to new medical
equipment.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections, etc.?*

A third party may legally import a registered second hand medical device
without being subjected to new safety inspections

*Can public health institutions buy used or refurbished medical devise?*

Public Health institutions may use refurbished medical devices

*Is there a market for used or refurbished medical devices?*

There is no important market for used medical equipmemt. Some private
(non governmental) institutions purchased used medical devices in the
past but the trend is to purchase new devices now.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

There is no important demand for used equipment.

## Malawi

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 15 October 1998 {#source-report-from-cs-post-via-cable-15-october-1998 .unnumbered}

Malawi has no policy, regulations, or restrictions on the importation of
used equipment, according to a representative of Malawi's Ministry of
Commerce and Industry.

\[This cable does not specifically address used medical equipment.\]

## Malaysia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 29 March 2002 {#source-report-from-cs-post-via-e-mail-29-march-2002-1 .unnumbered}

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

Medical devices and appliances have no import duty. No duty is imposed
on used medical devices or equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Government hospitals do not ban used or refurbished medical devices.
Howerver, due to safety reasons and after-sale service issues, they
prefer to buy new medical devices. Moreover, it is not common for
medical products distributors to sell used medical devices to public
hospitals.

*Is there a market for used pr refurbished medical devices?*

The market is very small, almost negligible.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Not applicable.

### *Source:* Industry Sector Analysis, *Healthcare Sector Overview*, 26 September 2001

Nearly all medical equipment, instruments and supplies are imported, and
the main exporters are the U.S. followed by Japan, Germany and
Australia. All medical products are not dutiable. While most imported
medical equipment is now more expensive due to the depreciation of the
local currency, many are still reluctant to use refurbished medical
equipment due to its safety concerns. Moreover, the level of health care
services still needs to be upgraded to satisfy the demands of an
increasingly affluent and health-conscious population. The Government of
Malaysia has still not imposed regulations on medical devices yet. It
was mentioned that the Medical Device Act is in its final stage and that
it will be implemented soon. However, certain high-tech medical
equipment, such as x-ray equipment, equipment that uses lasers and
others, are subject to stringent pre-purchase evaluation by the Ministry
of Health's Health Technology Assessment Unit.

## Mexico

###### No Restrictions when Imported by End-User; Restricted when Imported for Resale; Public Institutions Cannot Purchase

### *Source:* Industry Sector Analysis, Medical Equipment, 29 September 2001

Private clinics and sanatoriums usually purchase used equipment sold by
large public or private hospitals. They also buy domestically
refurbished equipment or refurbished equipment imported from the U.S.
Few clinics and sanatoriums have budgets for purchasing new equipment.

Medium size private hospitals may purchase new or refurbished equipment
depending on budget. Private medical centers mainly look for
state-of-the-art equipment. They like to get financial support from
manufacturers or distributors, when possible.

All private health care units select suppliers by requesting price
quotations. Their decisions are based on the best equipment at the best
price.

### *Source:* Report from CS Post (via E-Mail), 17 April 2000 {#source-report-from-cs-post-via-e-mail-17-april-2000 .unnumbered}

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

Same as specified in ISA, 1 February 1998 (*see below*). Requirements
have not changed.

*Can public health institutions buy used or refurbished medical
devices?*

No. Public institutions are not allowed to purchase used or refurbished
medical equipment in Mexico.

*Is there a market for used or refurbished devices?*

Yes. Most small and medium hospitals in Mexico lack of enough resources
to purchase new equipment. To optimize the use of funds, they look for
refurbished equipment that is in good operating conditions and have
technical support available.

*Best prospects?*

All kinds of medical equipment, instruments and accessories have good
potential in the Mexican market. Please see IMI 27 September 1999 (*see
below*).

### *Source:* IMI Medical, 10 December 1999 {#source-imi-medical-10-december-1999 .unnumbered}

#### Summary

On October 19-21, 1999, the U.S. Commercial Service, Mexico City, held
the first show in Mexico for refurbished medical equipment. The show was
a complete success. All companies participating had immediate sales or
obtained serious sale leads. The show will be repeated annually. Next
show will be held on October 17-19, 2000.

#### Body

On October 19-21, 1999, the U.S. Commercial Service, Mexico City, held
the first show and seminar series in Mexico for refurbished medical
equipment. In this show, 15 American companies exhibited a wide variety
of medical equipment and accessories. Also as exhibitors were a custom
broker, a publisher, an American trade association, and a Mexican
professional association. In the seminars, several exhibitors explained
the advantages of good refurbished medical equipment. The Mexican
association of biomedical engineering presented the Mexican end users
point of view and requirements, and a FDA officer presented the FDA
policies on this matter.

During the three days of exhibition, there were 972 qualified visitors,
including hospital and clinic managers, private doctors, and
distributors of medical products.

Floor sales reached us \$95,000.00 and potential sales for the next 12
months are estimated in \$2.2 million. Each exhibiting company obtained
an average of 50 sales leads as well as several potential agents or
representatives in Mexico.

After the successful 1999 event, the U.S. Commercial Service, Mexico
City has decided to annually organize an event for refurbished medical
equipment. The next will be held in October 17-19, 2000.

The October 2000 event will again include parallel seminars. Plans
include to increase the number of exhibitors and add the participation
of medical associations in Mexico.

This show will offer American companies the opportunity to:

-   Exhibit equipment or catalogs directly to the decision makers;

-   Participate in seminars to explain characteristics and benefits of
    their equipment and services;

-   Meet personally with the purchasing managers of medium and small
    hospitals in Mexico willing to discuss their products and services;
    and

-   Contact Mexican companies that are currently providing technical
    support to Mexican hospitals and that are available to be their
    technical counterpart in Mexico.

    Best prospects include:

+-----------------------------------+-----------------------------------+
| -   All kind of equipment for     | -   All kind of equipment for     |
|     gynecology                    |     urology                       |
+-----------------------------------+-----------------------------------+
| -   Anesthesia equipment          | -   Bronchoscopes                 |
+-----------------------------------+-----------------------------------+
| -   C-arms                        | -   Defibrillators                |
+-----------------------------------+-----------------------------------+
| -   Developing apparatus for      | -   Duodenoscopes                 |
|     x-ray plates                  |                                   |
+-----------------------------------+-----------------------------------+
| -   Electrosurgery equipment      | -   Endoscopy flexible apparatus  |
+-----------------------------------+-----------------------------------+
| -   Fluoroscopic equipmenty       | -   Gastroscopes                  |
+-----------------------------------+-----------------------------------+
| -   Hemodialysis machines         | -   Hospitals beds and furniture  |
+-----------------------------------+-----------------------------------+
| -   Hydraulic and ambulance       | -   Imaging equipment             |
|     stretchers                    |                                   |
+-----------------------------------+-----------------------------------+
| -   Incubators                    | -   Intensive therapy equipment   |
+-----------------------------------+-----------------------------------+
| -   Laparoscopy equipment         | -   Lithotriptors                 |
+-----------------------------------+-----------------------------------+
| -   Magnetic resonance            | -   Patient monitors              |
+-----------------------------------+-----------------------------------+
| -   Radiant incubators            | -   Sterilizers                   |
+-----------------------------------+-----------------------------------+
| -   Surgery instruments           | -   Surgery lamps                 |
+-----------------------------------+-----------------------------------+
| -   Surgery tables                | -   Transport incubators          |
+-----------------------------------+-----------------------------------+
| -   Ultrasounds                   | -   Urethroscopes                 |
+-----------------------------------+-----------------------------------+
| -   Vital signs monitors          | -   Volume and pressure           |
|                                   |     ventilators                   |
+-----------------------------------+-----------------------------------+
| -   X-rays                        |                                   |
+-----------------------------------+-----------------------------------+

#### Commercial Implications For U.S. Firms

The Mexican market for refurbished medical equipment has proven to be an
excellent niche for American companies that offer good quality products
with technical support and warranty.

### *Source:* IMI Medical 27, September 1999 {#source-imi-medical-27-september-1999 .unnumbered}

#### Summary {#summary-6 .unnumbered}

The Mexican market for refurbished medical equipment represents an
unexploited niche for American companies. Due to the economic
conditions, only large and medium private hospitals can afford
purchasing new equipment. Almost 85 percent private hospitals in Mexico
are currently purchasing or looking to purchase refurbished medical
equipment and devices.

#### Body {#body-1 .unnumbered}

Mexico has 2,945 private medical facilities. 0nly 3.2 percent or 95
units are large hospitals having more than 50 beds. The remaining 96.8
percent or 2,850 medical units are small clinics and hospitals having
from 5 to 49 beds.

The small and medium medical units do not have the financial resources
to buy new equipment. The preferred way they have to increase their
equipment inventory or to substitute obsolete equipment, is through the
acquisition of refurbished medical equipment that is in good conditions
and has availability of service and spare parts in Mexico.

Most of the 2,850 small and medium hospitals are already importing
refurbished equipment from the United States or are willing to do so.

If each of these hospitals invest at least US\$ 10,000 a year in
refurbished equipment, there is a potential minimum market of US\$ 28.5
million.

There are also 105,000 Mexican doctors with private offices. They like
to have their own small or portable equipment for better attention to
their patients, such as ultrasound, X-ray, imaging equipment,
microscopes, sterilizers, etc. If each of these doctors invest at least
US\$ 500 a year in refurbished equipment and devices, the potential
market would be of US\$ 75 million.

The key to this market is to offer equipment that is in good operational
conditions, at a good price and offering technical support in Mexico.

Best prospects include:

+-----------------------------------+-----------------------------------+
| -   All kind of equipment for     | -   All kind of equipment for     |
|     gynecology                    |     urology                       |
+-----------------------------------+-----------------------------------+
| -   Anesthesia equipment          | -   Bronchoscopes                 |
+-----------------------------------+-----------------------------------+
| -   C-arms                        | -   Defibrillators                |
+-----------------------------------+-----------------------------------+
| -   Developing apparatus for      | -   Duodenoscopes                 |
|     x-ray plates                  |                                   |
+-----------------------------------+-----------------------------------+
| -   Electrosurgery equipment      | -   Endoscopy flexible apparatus  |
+-----------------------------------+-----------------------------------+
| -   Fluoroscopic equipment        | -   Gastroscopes                  |
+-----------------------------------+-----------------------------------+
| -   Hemodialysis machines         | -   Hospitals beds and furniture  |
+-----------------------------------+-----------------------------------+
| -   Hydraulic and ambulance       | -   Imaging equipment             |
|     stretchers                    |                                   |
+-----------------------------------+-----------------------------------+
| -   Incubators                    | -   Intensive therapy equipment   |
+-----------------------------------+-----------------------------------+
| -   Laparoscopy equipment         | -   Lithotriptors                 |
+-----------------------------------+-----------------------------------+
| -   Magnetic resonance            | -   Patient monitors              |
+-----------------------------------+-----------------------------------+
| -   Radiant incubators            | -   Sterilizers                   |
+-----------------------------------+-----------------------------------+
| -   Surgery instruments           | -   Surgery lamps                 |
+-----------------------------------+-----------------------------------+
| -   Surgery tables                | -   Transport incubators          |
+-----------------------------------+-----------------------------------+
| -   Ultrasounds                   | -   Urethroscopes                 |
+-----------------------------------+-----------------------------------+
| -   Vital signs monitors          | -   Volume and pressure           |
|                                   |     ventilators                   |
+-----------------------------------+-----------------------------------+
| -   X-rays                        |                                   |
+-----------------------------------+-----------------------------------+

### *Source:* ISA Medical, 1 February 1998 {#source-isa-medical-1-february-1998 .unnumbered}

#### Refurbished Medical Equipment

This report focuses on used and refurbished medical equipment purchased
by small and medium private sector users. Distribution channels are
developing, as many end-users purchase directly from foreign sources.
This is an emerging and a so far unexploited market that offers very
good opportunities for U.S. exporters of such equipment.

Because of the market dependence upon imported equipment and a lack of
economic resources, small and medium private clinics have for decades
bought used medical equipment from large public and private hospitals.
Public health care institutions do not buy used or refurbished medical
equipment.

The high cost of medicine is also driving private doctors to install
portable or small equipment in order to provide simple laboratory tests,
analysis and outpatient surgery, and so help patients to avoid hospital
expenses.

The main distribution channel is through those medical equipment repair
firms serving specific clients. Most pieces of refurbished medical
equipment are purchased and imported directly by end- users. Statistical
information on the value of the imports is not available. This equipment
is included either as imports of new equipment, or as scrap or products
of limited value.

Some Mexican repair companies provide advice to their customers on the
purchasing and importing of used or refurbished medical equipment.
However, very few repair companies import directly for resale or to
maintain an inventory. Mexican Government Sanitary and Customs import
requirements are difficult to comply with and costly to implement. This
situation does not leave the Mexican repair firms with a reasonable
profit margin.

The Mexican market for refurbished medical equipment is estimated at
US\$ 14 million for 1997. Ninety percent of this market is supplied by
imports from the U.S. This market could grow at an annual average of
10-15 percent in the coming years if foreign suppliers offer warranties
and service in Mexico. Providing financial support to end-users would
also prove a very successful marketing strategy.

Best prospects include equipment for: anesthesia, hospital waste
management and treatment, intensive care, laparoscopy, patient
monitoring, radiotherapy, respiratory therapy, sterilization,
tomography, ultrasound diagnosis, and X-ray.

While public health care institutions and large private hospitals are
augmenting and modernizing facilities and equipment, they do not
purchase used or refurbished equipment. However, small and medium size
private hospitals do buy refurbished equipment and are improving their
facilities to provide more and better services.

##### Best Prospects

Best sales opportunities for refurbished medical equipment include:

+------------------------+----------------------+----------------------+
| -   Anesthesia         | -   Defibrillators   | -   Laboratory       |
+------------------------+----------------------+----------------------+
| -   Incubators         | -   Intensive care   | -   Tomographers     |
+------------------------+----------------------+----------------------+
| -   Respiratory        | -   Sterilization    | -   Ventilators      |
|     therapy            |                      |                      |
+------------------------+----------------------+----------------------+
| -   Ultrasound         | -   Diagnostic       | -   Patient          |
|     diagnosis          |     imaging          |     monitoring       |
+------------------------+----------------------+----------------------+
| -   X-rays             | -   Home care        |                      |
+------------------------+----------------------+----------------------+

The market for this equipment can increase if products are offered with
a warranty and a service provision. Offering financial assistance will
provide an excellent tool to develop the market. Those U.S. companies
who do not have a representative in Mexico could try signing contracts
with those Mexican companies offering medical equipment repair service
in order to offer technical support to buyers of used and refurbished
medical equipment. The best competitive factor to successfully penetrate
the Mexican market for used and refurbished medical equipment would be
offering credit to end-users. Many small private hospitals and private
doctors are willing to buy equipment but lack the immediate financial
capacity to do so.

Another important competitive factor is after sale service, including
training and spare parts availability. Of course, quality or properly
operating equipment is just as important.

Domestic production consists of imported used medical equipment used
sold by large Mexican public and private hospitals and refurbished by
Mexican companies for specific clients or for sale to others. This
refurbishing activity is very limited. Most used equipment sold by large
health care institutions is scrap, as it is usually in poor operating
condition. Some refurbishing firms cannibalize equipment---taking parts
for several units to complete one unit.

Some private hospitals buy used equipment from U.S. companies but hire a
Mexican company to refurbish the units. Very few Mexican firms import
used equipment for refurbishing and resale. The investment is too high
to be profitable.

The United States is the only foreign supplier of used and refurbished
medical equipment in the Mexican market. Some private hospitals and
doctors that imported refurbished equipment from Europe and Asia in past
years found the process of obtaining technical support or even parts for
the equipment very frustrating. End users of used and refurbished
medical equipment prefer suppliers with geographical proximity.

There is no official information on imports of used and refurbished
medical equipment. However, it is estimated that in 1997 these imports
reached US\$ 12.9 million. Most of these imports were made directly by
the end users.

End users of refurbished medical equipment are small and medium private
hospitals and private doctors who prefer to have small or portable
equipment in their offices. Public health care institutions currently do
not purchase used or refurbished medical equipment.

The recent Mexican economic crisis resulted in many small private
hospitals not being able to replace obsolete equipment and acquire new
units. Clinics and *sanatorios* have traditionally purchased the
equipment discarded by large public and private hospitals. They also buy
equipment that has been refurbished in Mexico or have directly imported
refurbished equipment from the United States. Some private hospitals
purchase used equipment, from domestic or U.S. sources, and hire a
company to refurbish it. These clients always seek to save money while
obtaining the best equipment. Very few clinics and *sanatorios* have
budgets for purchasing new medical equipment.

Medium size private hospitals may purchase new or refurbished units
depending on available budget, the condition of the equipment and its
capabilities. However, they often will not buy refurbished units because
they do not trust the condition of the equipment or a warranty or
technical support is not provided.

Private medical centers \[a 50+ bed hospital\] do not buy refurbished
equipment. They prefer state of the art units.

To be imported to Mexico, used and refurbished medical equipment and
accessories have to meet legal, technical and tax requirements. These
include applying for import permits with the Secretariat of Health and
complying with regulations on labeling, quality standards, certificate
of origin, duties and providing after sales services to clients.

##### Importation of Used Or Refurbished Medical Equipment For Resale

The Secretariat of Health specifies that only Mexican companies
registered as medical products distributors may import used or
refurbished medical equipment for resell. To be authorized, Mexican
companies must comply with the following requirements:

1\. Be legally established, registered and authorized as medical product
distributor. Authorization from the Secretariat of health is required.

2\. Designate a responsible person. This person must be a biochemical
engineer or the like, with the professional background and ability to
verify the equipment condition, according to specific tests.

3\. Maintain a registration log that is approved by the Secretariat of
Health. This log must contain all information concerning the importation
of the equipment, including:

+-----------------------------------------+----------------------------+
| -   Name of the apparatus               | -   Brand name             |
+-----------------------------------------+----------------------------+
| -   Importation sanitary permit number  | -   Date of import         |
+-----------------------------------------+----------------------------+
| -   Operation tests applied             | -   Name of importer       |
+-----------------------------------------+----------------------------+
| -   Invoice number                      | -   Sale or lease date     |
+-----------------------------------------+----------------------------+
| -   Warranty and services provided to   |                            |
|     end user                            |                            |
+-----------------------------------------+----------------------------+

4\. Present a document proving the sterilization system used, if
applicable.

5\. Present the equipment invoice specifying that the equipment is used
or refurbished and that it is in operating condition. If the equipment
or the apparatus is to be dismantled to obtain parts, it must be so
specified in the invoice.

6\. Offer warranty and technical services to customers.

7\. Present the FDA export certification.

8\. Comply with the Mexican standards for specific equipment such as
X-rays, infrared rays, etc.

##### Importation Of Used Or Refurbished Medical Equipment By The End User.

When the used or refurbished medical equipment is imported into Mexico
by the end user (hospital, private doctor), there are no barriers. The
only requirement is to obtain an import permit from the Secretariat of
Health and present the invoice specifying that the product is imported,
specifying if the equipment is used or refurbished and that it is for
private use and not for resale.

As there are no third persons involved, the importer is responsible for
the operation and use of the equipment. The importer will also need to
request directly from the supplier, a warranty or the technical support,
if offered by the seller.

##### Equipment Registration With The Secretariat Of Health

Used and refurbished medical equipment does not need to be registered
with the Mexican Secretariat of Health.

##### Labeling For Imports

On January 16, 1997, the Mexican Official Gazette published for
comments, NOM-137-SSA1-1995, which will regulate the labeling of health
care products, diagnostic agents and medical equipment whether
domestically manufactured or imported, including used and refurbished
equipment. This NOM is still in the process of being approved.

According to this standard, the label should contain:

8.  Product name (trademark or commercial name brand of the product).

9.  Name or business name and address of the manufacturer.

10. Name or business name and address of the importer.

11. Country of origin.

12. Sanitary registration number or letter specifying that registration
    is not required.

13. Expiration date or date of recommended consumption or use.

14. Lot or serial number.

15. Net contents (as specified in NOM-030-SCFI-1993).

16. Warnings or precautions on hazardous products.

17. Use, handling, and care instructions, when they are not obvious. If
    required, instructions must be attached. In these cases the label
    must specify-See attached instructions.

18. According to the consumers' law, the medical equipment label or
    instructions must specify the location of the repairs, and include
    instructions or manual and warranty.

19. For sterile products specify-sterility will not be granted if the
    original package is broken.

20. Legend specifying that the product is free of toxins or pyroxenes,
    when applicable.

21. Specification for disposable products, when applicable. Information
    required in points 3, 5, 9, 10, 11, 12, 13 and 14 may be attached to
    the products after the importation custom process, but before
    selling the product to the public. For bulk products, information is
    only required in the bulk container.

    These requirements do not apply to:

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1.  Highly specialized medical equipment.

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22. Medical equipment to be used in commercial, industrial or service
    areas.

23. Medical equipment imported by persons or institutions for their own
    use.

24. Medical equipment imported by educational or scientific
    institutions.

25. Samples of health care products or diagnostic agents imported to be
    used exclusively for the certification process to comply with
    Mexican standards.

26. Other medical equipment that because of size or nature cannot bear a
    label, or when the label size is not adequate to contain the
    information required. In such cases the Secretariat of Health will
    determine the course of action.

27. Other medical equipment, health care products or diagnostic agents
    determined by the Secretariat of Health.

    This information must be on products prepared for retail sale.
    Listing this information on the container in which a product is
    packed for shipment will not satisfy the labeling requirement. The
    above-mentioned requirements also comply with the labeling standard
    NOM-050-SCFI.

    There are few Mexican standards for medical equipment and
    accessories, but various agencies are preparing more standards to be
    issued in the near future. As of January 1998, Official Standards
    for medical equipment are:

-   NOM-001-SCFI-1993 for ultraviolet & infrared ray apparatus published
    in the Official Gazette, October 13, 1993.

-   NOM-003-SCFI-1993 for electric massage apparatus, published in the
    Official Gazette, October 13, 1993.

-   NOM-157-SSA1-1996, for protection and security measures for the use
    of diagnostic X-ray equipment, published in the Official Gazette,
    September 29, 1997.

-   NOM-158-SSA1-1996, for technical specifications for X-ray medical
    equipment, published in the Official Gazette, October 20, 1997.

The December 28, 1995 decree provides a list of products by Mexican
tariff number, which are subject to NOMs. A clarification and update of
this list was published on June 28, 1996, but that list is not
all-inclusive. All NOMs apply the same for new and used or refurbished
pieces.

For information on the NOM certification process, please consult the
Industry Sub-sector Analysis (ISA) on the Process of Standardization and
Certification in Mexico, by Jesus Gonzalez, September 1996, and
available on the National Trade Data Bank.

##### Certificate of Origin

The basic Mexican import document is the *pedimiento de importación*. A
commercial invoice must accompany this document (in Spanish), a bill of
lading, and documents demonstrating guarantee of payment of additional
duties for undervalued goods (see 'Customs Valuation') if applicable,
and documents demonstrating compliance with Mexican product safety and
performance regulations (see 'Standards'), if applicable. The import
documentation should either be prepared or submitted by a licensed
Mexican customs broker, or by a person with customs experience.

Products qualifying as North American must use the NAFTA Certificate of
Origin in order to receive preferential treatment. This may be issued by
the exporter or broker and does not have to be validated or formalized.
Certificate of Origin information is available on the NAFTA Facts in
documents 5000-5003 at telephone number (202) 482-4464. The Certificate
of Origin may be issued by government agencies, producers, exporters, or
industrial and commercial chambers of commerce or associations that are
legally authorized in the U.S. or other countries.

Mexican customs law is very strict regarding proper submission and
preparation of customs documentation. Errors in paperwork can result in
fines and even confiscation of merchandise as contraband.

##### Import Fees

Used or refurbished medical equipment pays the same import duties as new
units. The following 52 products, classified under the harmonized
system, are listed. Under NAFTA, starting in January 1998, 50 of these
codes are duty free for American products, against 10 to 20 percent
ad-valorem duty for third country products. (*See table below.*)

Mexico Tariff Schedule

  --------------------------------------------------------------------------
  Harmonized   Current       Product                            NAFTA Tariff
  Numbers      Import Duties                                    Reductions
  Schedule     Other/USA                                        
  ------------ ------------- ---------------------------------- ------------
  9011.1001    10/0          Microscopes for surgery            B

  9011.1099    20/0          Other microscopes                  B

  9011.2099    20/0          Microscopes for Micro projection   B

  9011.8099    20/0          Other microscopes                  B

  9011.9001    10/0          Microscope accessories             B

  9012.1001    10/0          Diffraction apparatus              A

  9012.9001    10/0          Accessories for diffraction        A
                             apparatus                          

  9013.2001    10/0          Lasers, other than laser Diode     A

  9018.1101    10/0          Electrocardiographs                A

  9018.1201    15/0          Ultrasound diagnostic apparatus    A

  9018.1301    10/0          Magnetic resonance imaging         A
                             Apparatus                          

  9018.1401    10/0          Nuclear medicine diagnostic        A
                             Apparatus                          

  9018.1901    10/0          Tonometers & retinoscopes          A

  9018.1902    10/0          Electro-encephalographers          A

  9018.1904    10/0          Diathermy apparatus, short-wave    A

  9018.1905    15/0          Patient monitoring equipment       A

  9018.1906    0/0           Audiometers                        FREE

  9018.1907    10/0          Cardioscope                        A

  9018.1908    10/0          Gamma ray apparatus                A

  9018.1909    15/0          Incubators                         A

  9018.1910    10/0          Electro-surgical apparatus         A

  9018.1911    10/0          Dermatomere                        A

  9018.1912    10/0          Defibrillator & surgical           A
                             appliances                         

  9018.1913    10/0          Electro-ejaculators                A

  9018.1999    10/0          Other medical apparatus            A

  9018.2001    10/0          Ultraviolet & infrared ray         A
                             apparatus                          

  9018.9004    15/0          Anesthetic apparatus               A

  9018.9005    15/0          Equipment for cephalorachidian     B
                             liquid control                     

  9018.9014    10/0          Pleural suction pumps              B

  9018.9015    20/0          Suction apparatus                  A

  9018.9020    10/0          Actinotherapy apparatus            A

  9018.9022    10/0          Accessories for anesthetic         A
                             apparatus                          

  9018.9025    10/0          Electronic detectors of Pregnancy  B

  9018.9026    10/0          Modular circuits for Electronic    B
                             detectors of Pregnancy             

  9019.1001    10/0          Hydrotherapy & mechano-therapy     A
                             appliances                         

  9019.1002    15/0          Massage apparatus                  A

  9019.1003    10/0          Accessories for therapy appliances A

  9019.1099    10/0          Other therapy apparatus &          A
                             accessories                        

  9019.2001    10/0          Respiration therapy apparatus      A

  9021.1904    10/0          Appliances for fracture treatment  A

  9021.2199    10/0          Other accessories                  A

  9021.5001    10/0          Pacemakers for stimulating heart   A
                             muscles                            

  9021.9099    10/0          Other orthopedic appliances        A

  9022.1201    10/6          Tomography equipment               C

  9022.1401    10/0          X-ray equipment                    A

  9022.1499    10/0          Other radiation equipment          A

  9022.2101    10/0          Cobalt pumps                       A

  9022.2199    10/6          Other radiation apparatus          C

  9022.2901    10/0          Calibrators beta                   A

  9022.3001    10/0          X-ray tubes                        A

  9022.9003    10/0          Accessories for X-ray apparatus    A

  9022.9099    10/0          Other parts or accessories for     A
                             X-ray apparatus                    
  --------------------------------------------------------------------------

A: Full duty elimination occurred on January 1, 1994.

B: Full duty elimination occurred on January 1, 1998.

C: Duties shall be removed in 10 equal stages of 10 percent of the NAFTA
base rate. This reduction began on January 1, 1994, with full duty
elimination on January 1, 2003.

The Import Duty is calculated on the U.S. plant value (invoice) of the
product(s) plus the inland U.S. freight charges to the border and any
other costs listed separately on the invoice and paid by the importer
such as export packing. In addition, a customs processing fee (CPF) of
0.8 percent is assessed on the total of the selling price of the
product, inland freight cost, other fees (export packaging), plus duty
paid and the custom broker fee, if this service is employed.

According to recent modifications in the Mexican customs law, the
participation of a customs broker is not obligatory for imports if all
legal and technical requirements are met. The participation of a customs
broker is suggested when the exporter is not familiar with the Mexican
standards and customs processing procedures.

A 15 percent value-added tax (IVA) is then assessed on the cumulative
value consisting of the U.S. plant value (invoice) of the product(s),
plus the inland U.S. freight charges, any other costs listed separately
on the invoice such as export packing plus the duty. The importer will
pay other IVA fees for such services as the inland Mexico freight and
warehousing. The IVA is recovered at the point of sale.

##### Distribution/Business Practices

The distribution of refurbished medical equipment in Mexico is not
developed. Most end users import equipment directly into Mexico, for
their personal or institutional use.

Very few companies are legally registered with the Secretariat of Health
to sell or distribute imported refurbished medical equipment. Companies
involved in this business are mainly those offering repair service and
equipment for lease. These firms advise end users on the equipment to
buy. The end user negotiates the price and warranty with the foreign
supplier. The equipment is imported by the end user and the Mexican
company offers maintenance and repair service.

Sometimes, Mexican repair companies arrange with foreign suppliers to
provide repair service to the end user as part of the equipment purchase
contract.

Few repair companies have a product display area or stock equipment for
immediate delivery. Only companies offering equipment for lease carry an
inventory. It is common for leasing companies to offer a purchase
option.

There are many American companies already selling refurbished medical
equipment to Mexican hospitals. However, none of them have branch
offices or exclusive representatives in Mexico. Many repair companies
and distributors of new equipment sell only one or two medical equipment
lines. Others include the selling of instruments or supplies.

##### Service

Service is one of the most important competitive factors for used and
refurbished medical equipment. Most hospitals prefer to have permanent
maintenance services and repairs accomplished within 24 hours. This
means that spare parts and trained technicians must be available to
respond adequately to client requirements.

It is important that new-to-market firms make a careful selection of a
repair firm to represent the US firm and be sure that the Mexican
company has the capability to provide timely and quality service.

Large distributors of new equipment usually have nationwide coverage;
technical departments, a strong sales force and a solid financial
background, but do not like to sell refurbished equipment.

## Moldova

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 5 April 2001

According to the Ministry of Health and Customs Department, there are no
restrictions for import \[*but see conditions listed below*\] and sale
of used/refurbished medical equipment. Imports of used equipment are
treated the same as new. Duties are charged based on the cost of the
product. Documentary evidence of cost is preferred.

Generally speaking, three types of taxes are paid on all imports of
medical equipment:

-   Tax on customs procedures which typically constitutes 0.25 percent
    of the value of shipment;

-   20-percent value added tax;

-   customs tariff tax which is 0% for most medical equipment.

Donated medical equipment is exempted from any customs duties.

The decision to allow certain medical equipment into the country is made
on a case-by-case basis. The adequacy of any medical equipment brought
into Moldova is assessed against an internal regulation of the Ministry
of Health dealing with donated medical equipment. As a rule, the
Ministry will allow into the country equipment less than ten years old
(from the date of manufacture). The regulation sets the following
requirements for medical equipment:

1.  It should be accompanied by documents certifying the origin,
    quality, name and type of item, name of producer, date of
    manufacture, date of installation, name of the institution that has
    been using the equipment, date of de-installation, whether or not
    the equipment is operational, technical specifications and warranty
    period;

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```
28. Any container should be accompanied by a document containing
    information on the number of packages, size, and weight;

29. Information has to be provided for each package concerning the name
    and type of the item, manufacturer, number of items in the package,
    date of packaging;

30. The cost of equipment has to be similar to the country of export or
    world level;

31. Proper operational guides must be provided.

The market for used/refurbished equipment in Moldova is extremely
limited. However, Moldovan public health institutions use some small
amounts of used equipment which has been donated by institutions and
individuals from overseas, including the United States. Although prices
for used/refurbished equipment tend to be significantly smaller that
those for brand new equipment, the paying ability of Moldovan public
health providers is still very small. Private health institutions are
few and account for only a small portion of the health services market.
Most purchases made by public health institutions are made through
public tenders.

Few medical equipment distributors exist in Moldova. The state-owned
company Moldtehoptimed is the most important provider of medical
equipment. Separate licenses which are issued by the Ministry of Health
are required for each of the following activities:

1.  Dealing in medical equipment and

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32. Importation of medical equipment.

## Morocco

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 21 April 2003

#### Summary

Approximately 20 percent of the total imported medical equipment is used
or reconditioned. It consists of heavy equipment such as X-ray machines,
magnetic resonance imaging apparatus, ultrasonic scanning apparatus,
patient monitoring systems (except medical equipment that require direct
contact with internal organs), surgery equipment and operating tables,
sterilization equipment, and bedding (except mattresses). This equipment
is used by private hospitals, known as "clinics," private specialty
hospitals known as "centers," such as radiology centers, cardiology
centers, dialysis centers, and private testing laboratories.
Reconditioned equipment with guarantees offers excellent opportunities.

#### Public Sector

Under the Moroccan regulations, the public sector is required to
purchase medical equipment through tenders. Although no law forbids
purchase of used equipment, tender documents often require procurement
of new equipment. Three government entities provide healthcare and
purchase medical equipment. These are the Ministry of Health (*Ministère
de la Santé*), the National Social Security (*Caisse Nationale de
Securité Sociale---CNSS*), and the Ministry of Defense (*Ministère de la
Defense*). They respectively provide healthcare through "hospitals,"
"polyclinics" and "military hospitals," and they have independent budget
and complete autonomy in purchasing medical equipment.

#### Regulatory Agency

The Ministry of Health is the government agency in charge of the
Moroccan healthcare system.

#### Regulations

Under the Moroccan law 005/71 of October 12, 1971 on Protection against
Ionization, import into Morocco of new or used radiology equipment
requires a special authorization from the Center of Protection against
Radiation of the Ministry of Public Health.

For used equipment, U.S. exporters must provide Moroccan buyers with the
following:

-   Compliance certificate

-   FDA authorization

-   Technical documentation/directions for use of the product

-   Certification that the equipment is in good Electro-technical and
    radiological working order

-   Documentation/history on previous maintenance.

When a manufacturer or its agent has registered a medical device in
Morocco, a third party cannot legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections. For any piece of used/refurbished medical
equipment that enters the country, the third party, as did the
manufacturer or its agent, must provide the same as above, namely:

-   Compliance certificate

-   FDA authorization

-   Technical documentation/directions for use of the product

-   Certification that the equipment is in good Electro-technical and
    radiological working order

-   Documentation/history on previous maintenance

#### Import Documentation

Medical equipment and device other than radiation equipment requires
approval from the Ministry of Health that the equipment meets Moroccan
health standards. Morocco recognizes certifications provided by the FDA.

A commercial invoice is required. The commercial invoice should fully
describe the goods in French. Certification as to country of origin is
required. Payments are made through bank-to-bank irrevocable letters of
credit. Pro-forma invoices must be provided in most cases. Invoices,
which should be on company letterhead, are required for both import
licenses and foreign exchange transfers. \"To order\" bills are
acceptable as bills of lading.

#### Labeling Requirements

No special regulations apply to the exterior marking of containers for
shipments to Morocco. Indication on outer containers of the net weight
in kilograms, and other identification markings, will however assist in
locating goods on arrival and speed their clearance through customs.

#### Import duties and taxes

There are no restrictions or tariffs that apply to used or reconditioned
medical equipment. New or used medical equipment is subject to 2.5
percent import duties paid on ad valorem. There is a value-added tax of
20 percent paid on the compounded ad valorem and import duties.

#### Standards

Morocco uses the metric system exclusively and the 220 Voltage. Dates
should have the date format dd/mm/yy. Literature in the French language
is recommended.

#### Distribution

Foreign firms sell into the Moroccan market through distributors/agents.
Agents/distributors are often necessary to assist the U.S. firm with
documentation in the French language. Key to success in the used medical
equipment sector lay in the technical support and warranty given to
end-users of reconditioned medical equipment.

## Mozambique

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 5 April 2001 (Information confirmed 20 February 2002)

Regarding special restrictions or tariffs applied to used equipment, the
Mozambican Customs Authority does not levy any restrictions. Used
imported medical equipment is treated as new, and is liable for duties
stated in the harmonized tariff in force.

Public health institutions can purchase used or refurbished medical
equipment provided that it is in good condition. Maputo has sixteen
private clinics and several hospitals that may be interested in used or
refurbished d medical equipment at affordable prices.

### *Source:* Report from CS Post (via Cable), 31 March 2000 (Information confirmed 20 February 2002)

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

No, the Mozambican customs office does not apply any restrictions or
tariffs to the importation of used medical equipment, although such
products are liable to normal duties stated in the harmonized tariff
schedule.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, they can purchase used or refurbished medical devices, provided
they are in good condition.

*Is there a market for used or refurbished devices?*

Perhaps, although only at a low volume in a very limited number of
institutions. Maputo has sixteen private the clinics that may be
interested in used or refurbished medical equipment if offered at
affordable prices.

## Nepal

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 16 April 2003

*Are there special restrictions or tariffs that apply to used-medical
equipment that do not apply to new medical equipment?*

The Government of Nepal requires no licensing of medical equipment and
imposes no specific restrictions on used medical equipment. Tariff rates
for medical equipment, as per the Harmonized Tariff Schedule of Nepal,
range from 5 to 10 percent. On top of the tariff, an importer is
required to pay 10 percent Value Added Tax (VAT) and 1.5 percent Local
Development Tax on the gross value of the equipment (invoice value +
tariff).

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc\...?*

No specific license or registration is required for importing used or
new medical equipment. Private nursing home/hospitals importing
equipment must attach a copy of their corporate registration certificate
for getting foreign currency approval from the Nepal Rastra Bank
(Nepal\'s central bank) and customs clearance of the consignment.
Private traders, who deal in such equipment, need to show their general
export/import license.

*Can public health institutions buy used or refurbished medical
devices?*

Public health institutions are free to import used and refurbished
medical devices to meet their needs. However, none of the public health
institutions contacted by the Embassy have done so---the used equipment
they receive has been donated.

*Is there a market for used or refurbished medical devices?*

No market survey is readily available regarding new or used medical
equipment. However, the Embassy assesses that there is a potential
market for high-value used medical equipment\--devices like X-ray
machines and ultrasound machines, which are relatively inexpensive, are
normally imported brand new.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Products like CT Scan and MRI may have some demand in the Nepalese
market.

#### Government of Nepal Contact

Secretary, Mahendra Nath Aryal\
Ministry of Health\
His Majesty\'s Government of Nepal Ram Shah Path\
Kathmandu, Nepal\
Phone: 977-1-426-2590\
Fax: 977-1-426-2706

## Netherlands

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via e-mail), 25 April 2003.

*Are there special import duties or restrictions on used medical
equipment that don\'t apply to new medical equipment?*

No. The Netherlands has no import restrictions specifically applicable
to the importation of used equipment. Imports of used equipment are
treated in the same way as new products.

*If a manufacturer or its agent has registered a medical device in the
Netherlands, can a third party legally import the same device in used or
refurbished condition without the used device being subject to new
safety inspections?*

Because sales of used equipment in the Netherlands need to be approved
by the original manufacturer, the device should not be subject to new
safety inspections. Most used equipment imported into the Netherlands is
not sold here but is refurbished and exported to developing countries.

*Can Dutch public health institutions buy used or refurbished medical
devices?*

Yes.

*Is there a market for used or refurbished medical devices?*

The market for used and refurbished equipment plays a minor role in the
Dutch economy. A relatively high standard of living combined with
government incentives and tax deductions stimulate the purchase of new
as opposed to used equipment. Equipment in the Netherlands is usually
replaced long before its technical value has expired. In the respect,
the Netherlands exports significant quantities of use equipment itself.
Refurbished medical equipment is one area where there is potential for
U.S. suppliers. Budget cuts and the necessity to save money on large
capital outlays are forcing Dutch hospitals to consider purchasing
refurbished equipment. However, there is still resistance to buying used
medical equipment within the sector. The Dutch manufacturer Philips
Medical System now offers a line of refurbished Philips diagnostic
equipment under the name *Philips Select*.

## New Zealand

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 2 May 2000

New Zealand's current legislation controlling the manufacture, import
and distribution of medical devices (including used medical devices) is
expected to change when the New Zealand and Australian Governments
finalize their discussions on a joint therapeutic goods regulatory body.
The discussions are still at a preliminary stage, but once the
consulting process is completed and new legislation is passed by both
the Australian and New Zealand Governments, no medical device will be
accepted into New Zealand unless it is recorded on the joint register.
There will be various criteria for a device to be accepted on the
register. It is expected the proposed joint regulatory body will be
operative in 1-2 years time.

Under the existing regulation, it is possible to import medical devices
into New Zealand (provided they meet internationally-recognized
standards) with very little Government intervention. The existing
legislation does not require medical devices to be registered. The
market relies on compliance by importers and manufacturers to
established standards that is enforced by post-market surveillance.
Medsafe is the Government agency that oversees the post-market
surveillance.

Though existing legislation makes it possible to import used medical
equipment into New Zealand Medsafe could intervene if it had concerns
over the safety of used equipment. As a result and in view of this
country's medical device legislation soon changing, medical device
companies looking to do business in New Zealand should contact Medsafe
first before entering this marketplace. The business contact details
are:

  ----------------------------------- -----------------------------------
  Trevor Nisbet\                      Ph: 64 (4) 496-2364\
  Senior Adviser (Science)\           Fax: 64 (4) 496-2599\
  Medsafe\                            Website: www.moh.govt.nz\
  Public Health Directorate\          Email: trevor_nisbet@moh.govt.nz
  Ministry of Health\                 
  PO Box 5013\                        
  Wellington\                         
  New Zealand                         

  ----------------------------------- -----------------------------------

## Nicaragua

###### General Market Condition: No Restrictions, but Ministry of Health Does Not Buy

### *Source:* Report from CS Post (via Cable), 27 March 2000

According to the Nicaraguan Customs Department and Ministry of Health,
there are no restrictions for the importation of new, used and/or
refurbished medical equipment into Nicaragua. New, used and/or
refurbished medical equipment have a zero percent tariff.

The Nicaraguan Ministry of Health only purchases new equipment. Local
clinics and private hospital do purchase used or refurbished medical
equipment.

Our assessment is that there is a market for used or refurbished
equipment.

Best prospects include intensive care, surgical, laboratory and X-ray
equipment.

Import of medical equipment from the U.S. into Nicaragua over the past
three years is estimated at \$8.3 million for 1997, \$8.8 million for
1998 and \$l0.0 million in 1999.

## Nigeria

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 2 May 2000

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

No.

*Can public health institutions buy used or refurbished medical
devices?*

Yes.

*Is there a market for used or refurbished devices?*

Yes

*Best prospects?*

Scanners, diagnostic equipment, medical disposables and ECG equipment.

### *Source:* IMI Medical, 9 March 2000

### Summary

Nigeria still depends on imports for most of its medical equipment
needs. Local production is limited to peripheral items such as hospital
beds and gurneys.

The Nigerian year 2000 budget is yet to be released, therefore this
report is hinged on projections for 1999 which to the best of our
knowledge is still very relevant. The Government of Nigeria will spend
an estimated US\$ 125 million on hospital equipment this fiscal year. It
also restated its commitment to the resuscitation of the nation's health
care delivery system through systematic funding and mobilization in line
with the Bamako Initiative Program, a series of reforms in response to
the deterioration of public health systems in developing countries. As
in the previous years, private sector participation continues to account
for much of Nigeria's imports in 1998, valued at approximately US\$ 400
million.

The 1998 - 2000 national rolling plan objectives also include the
completion of teaching hospital projects at Ahmadu Bello University,
Zaria, University of Nigeria, Nsukka, and Ado Bayero University, Kano,
rehabilitation of Ibadan University teaching hospital and equipment of
several medical health centers and primary health care centers.

There is no doubt that the political situation and the resultant
economic crunch had some negative effects on imports. However, with the
change in government and possible political and economic reforms, this
sector promises strong growth rates with an increasing demand for
equipment such as analytical and examination instruments, ultra sound
scans, anesthesia equipment, mortuary and laboratory equipment.

Nigeria's health policy is centered on primary health care delivered
through an estimated 15,500 health institutions. The caption 'Health For
All By The Year 2000', still remains the cornerstone of the Nigerian
health care sector and therefore health care delivery is still high on
the Nigerian government priority list. A number of projects are funded
by the world bank under different loan agreements, especially for the
rural areas.

The purchasing power of most Nigerian end-users is waning owing to
devaluation of the national currency, and the widening gap between new
technologies and developing economies. Refurbished and used equipment
are therefore in high demand. A significant segment of this market in
Nigeria is dominated by imports from Europe. However, U.S. Suppliers
stand a good chance of competing successfully because Nigerians like
U.S. equipment.

For further details, interested U.S. firms should contact the Commercial
Service at the U.S. Embassy, Lagos, at the mailing address below:

The Commercial Service\
U.S. Embassy, Lagos\
Department Of State\
Washington, DC 20521-8300

Tel. Number In Nigeria: 234--1-2610241\
Fax Number In Nigeria: 234-1-2619856

### *Source:* Report from CS Post (via Cable), 2 October 1998

There are no regulations for importation of used equipment in Nigeria.
Official guidelines relating to import duties, use of letter of credit
for payment of imports and containerization of imports valued more than
US\$ 1,000 apply to both used and new equipment.

Import duties on used equipment are the same as for new. Duties are
determined by the Nigerian customs service based on the invoiced value
of equipment and an import duty report (IDR) issued by a
government-appointed inspection agent.

Like several other imports, used equipment is often imported into
Nigeria overland through third countries and ports, and as accompanied
luggage of air travelers. Currently Nigeria's market for used equipment
is dominated by imports from Germany, the Netherlands, Belgium, and the
United Kingdom.

Price is the single most important driver of imports in this sector of
the Nigerian market. Several local firms interested in used U.S.-origin
equipment and parts including vehicles complain of high cost of
importation from the United States, which according to them often
results in an uncompetitive pricing strategy. Nigeria is a growth market
for U.S.-origin products and services, but requires patience,
resilience, a long-term relationship with a local partner (not a
customer) and an export-cost strategy that recognizes Nigeria's large
population but low per-capita income.

## Norway

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also the entry for the European Community.*

### *Source:* Report from CS Post (via E-Mail), 14 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No, there are no special restrictions or tariffs that apply to used
medical equipment. The same rule applies to both new and used medical
equipment. In general, Norway follows EU and European Economic Area
(EEA) directives. Norway requires the CE mark on all medical equipment,
used or new.

Concerning registration of companies and their devices, Norway has
chosen to go a little further nationally than what is strictly required
by the EU directives. Obligation to register with the Norwegian Register
for Medical Devices, Manufacturers and Distributors is incumbent upon
all companies manufacturing or trading with medical devices, and with a
business address in Norway. A company may be a manufacturer, a
manufacturer\'s authorized representative in the EEA, a sole
distributor, a distributor, or a combination thereof. The national
authority overseeing this register is the Norwegian Directorate for
Health and Social Affairs.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc.?*

No, the third party must still register the product and the company with
the Norwegian Register for Medical Devices, Manufacturers and
Distributors and the product must still carry the CE mark.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, they are allowed to buy used or refurbished medical equipment as
long as the products comply with current regulations, but so far there
has been no indication that they are interested in doing so.

*Is there a market for used or refurbished medical devices?*

According to Norwegian government, procurement and trade association
sources there has not been a market for used or refurbished medical
equipment. When replacing outdated medical equipment the public health
institutions prefer to purchase new equipment.

*If there is a market, what types of used or refurbished medical
equipment are in greatest demand?*

Not applicable.

## Oman

###### General Market Condition: No Restrictions, but Ministry of Health Does Not Buy

### *Source:* Report from CS Post (via Cable), 29 March 2000 (Updated and Corrected by CS Post (via Cable), 2 April 2001)

The Ministry of Health is the main buyer of medical equipment in Oman.
As a matter of practice, the Ministry of Health does not purchase used
or refurbished medical equipment. Normally, when the ministry decides to
purchase equipment, it contacts regular suppliers and requests the
latest equipment; in some cases such purchases are conducted through
tenders. Generally, equipment is purchased along with a minimum
five-year maintenance contract.

Post does not know of any special restrictions or tariffs that apply to
used medical equipment that do not apply to new medical equipment.

Given the Ministry of Health's practice of purchasing new equipment
only, prospects for sales of used and refurbished medical equipment in
Oman remains extremely limited. It is possible that private hospitals
and clinics could be potential purchasers of used medical equipment
since their procurement does not go through the Ministry of Health.
However, at this time, there are only two private hospitals in Oman.

## Pakistan

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 6 April 2001

Pakistan offers a promising market for used or reconditioned medical
equipment and devices such as diagnostic equipment, electro-medical
apparatus and laboratory equipment. Demand is expected to grow at an
accelerated rate for items such as dialysis machines, diagnostic
equipment, electro-cardiographs, scanners and X-ray apparatus.

In recent years, thousands of new medical centers have been set up all
over the country. The majority of these private centers/clinics are run
by reputable medical professionals. The increasing involvement of the
private sector in health facilities is a positive development for U.S.
suppliers of used medical equipment to consider marketing their products
in Pakistan.

Under the import policy for 1999-2000, customs duty and sales tax on
used medical equipment are as follows:

Summary of Import Policy Order, 1999-2000 For Used Medical Equipment

  ------------- ------------------------------ --------------------------
  HS Code       Description of Goods           Relevant Rules Under
                                               Import Policy Order
                                               1999-2000

  9018.1 to     Second hand or used surgical   Import shall be allowed
  9018.19       equipment like dialysis        subject to the condition
                machines and electro-medical   that these are not more
                equipment                      than five years old.

  9018.13       Second-hand/used diagnostic    
                equipment                      

  9018.19       Testing equipment/analytical   Import of this equipment
                                               shall be

  9024          Equipment including CT scanner allowed if importer
                                               arranges for the

  9026          MRI equipment, etc.            foreign exchange
                                               resources.

  9027          Instruments for physical and   
                chemical analysis              

  9030          Instruments for measuring and  
                testing electricity and        
                electrical signals             

  9031          Other measuring and checking   
                instruments                    
  ------------- ------------------------------ --------------------------

#### Customs and Sales Tax {#customs-and-sales-tax .unnumbered}

Customs duty and sales tax on imported used medical equipment is as
follows:

Customs Duty and Sales Tax on Imported Used Medical Equipment

  ----------- ---------------------------- --------------- ----------------
  HS Code     Description Of Goods         Customs Duty\   Sales Tax on
                                           (ad valorem)    Imports

  9018.1100   Electro-cardiographs         10%             15%

  9018.1200   Ultrasonic scanning          10%             15%
              apparatus                                    

  9018.3100   Syringes with or without     25%             15%
              needles                                      

  9018.9070   Cine angiography film        10%             15%
              equipment                                    

  9022        Apparatus based on the use   15%             15%
              of X-rays                                    
  ----------- ---------------------------- --------------- ----------------

#### Customs Duty and Tax Exemptions on the Items Imported by Non-Profit Institutions  {#customs-duty-and-tax-exemptions-on-the-items-imported-by-non-profit-institutions .unnumbered}

Below is a list of used medical equipment that, if imported by a
charitable non-profit institution or by a hospital run by the Federal or
provincial government, is exempt from customs duty and sales tax:

Used Medical Equipment Exempt from Customs Duty and Sales Tax\
if Imported by Charitable, Non-Profit Institutions or\
Hospitals Run by the Federal or Provincial Government

  ----------------- -----------------------------------------------------
  HS Code           Description of Goods

  9018.11           Electrocardiographs

  9018.12           Ultrasonic scanning apparatus

  9018.13           Magnetic resonance imaging apparatus

  9018.14           Scintigraphic apparatus

  9018.19           ETT machine, Echocardiography, Electro-cenephlograph,
                    Radio-isotope scanners,

  9018.90           Angioplasty balloon, Cardiac catheters, Endoscopy
                    equipment

  9018.80           Dialysis equipment

  9018              Medical instruments
  ----------------- -----------------------------------------------------

### *Source:* ISA Medical, 1 March 1998 {#source-isa-medical-1-march-1998 .unnumbered}

Public sector hospitals procure medical equipment through tenders
whereas private hospitals obtain these through distributors and
suppliers who can ensure quality, technical services, and backup
supplies. U.S. manufacturers benefit by appointing agents in Pakistan's
major cities to market their superior quality products.
Used/reconditioned equipment is often preferred as the private sector is
price-driven. Import duties and sales tax were reduced in 1997.

Private sector health care is a significant factor in the market as more
private hospitals are being established, generating a demand for
imported equipment. Most private hospitals and clinics are set up as
commercial ventures by local or expatriate Pakistani doctors. Most of
these end-users seek either used or reconditioned equipment or, if new,
they source it from the cheapest supplier.

The equipment listed above is imported either new or used. Generally,
the following considerations are taken into account by end users when
deciding between new or used machinery/equipment:

-   Size---When the end user is a large hospital/organization, the
    preference is for new machinery/equipment.

-   Value---When high value machinery is imported, and there is an
    appreciable difference in the price of new and used items, the
    preference is for used items, e.g. magnetic resonance imaging
    system, computerized tomography scanners.

-   Basic Use Items---When the machinery/equipment to be imported is
    basic, involving simple technology, the preference is to import new
    items, e.g. ultra sound scanners, ophthalmic appliances.

### *Source:* ISA Laboratory, 1 October 1998 {#source-isa-laboratory-1-october-1998 .unnumbered}

Most laboratory and analytical equipment is being imported---either new,
used or in reconditioned form. The general criteria for importing new
machinery are low prices and appropriate technology. For example, basic
items are imported new; the relatively expensive items are imported both
in new and used forms. Larger hospitals generally prefer new items even
if they are expensive, but the smaller laboratories or individual
doctors prefer used items.

## Panama

###### Market Condition: No Restrictions, but Public Institutions Cannot Buy

### Source: Report from Post (via E-Mail), 25 April 2003

#### Regulatory Agency

The Ministry of Health manages the health care system in Panama. Along
with the Social Security System, it is responsible for procuring all of
the medical equipment in the public sector. Private hospitals and
clinics are the other major buyers of medical equipment in Panama.

#### Regulations

There are no local additional regulations, technical or safety
standards. Both U.S. and European standards are accepted in Panama.
There is a requirement however, to provide Spanish language labeling.
Labels may be multi-lingual (e.g., in English and Spanish), but Spanish
is required.

#### Import Duties and Taxes

In 1998 import duties for medical equipment were lowered to 10 percent,
from the previous levels of 35 percent and 27.5 percent. Import duties
in Panama are assessed on the CIF value. Additionally, a 5-percent value
added tax is charged on the aggregate of the CIF value plus the import
duty.

#### Used Equipment

There are some market opportunities for used/refurbished medical
equipment, especially in small hospitals and private hospitals in the
interior of the country. The government does not purchase used or
refurbished equipment. There are no special regulations for used
equipment in comparison to new equipment.

Medical equipment in high demand includes: cardiovascular,
electro-diagnostic, ultrasound, anesthesia, intensive care, dental,
optical, and ozone-therapy equipment.

Third-party companies legally can import any equipment in
used/refurbished condition without the need for new safety inspections,
etc.

#### Contact Information

##### Government Agencies

Colon Free Zone Administration\
P.O. Box 1118 ZLC, Panama\
Phone: (507) 445-1033\
Fax: (507) 445-2165\
E-mail: <zonalibre@zolicol.org>\
Contact: Jorge Fernandez, Director

Caja de Seguro Social\
P.O. Box 1393\
Panama 1, Panama\
Phone: (507) 261-8002\
Fax: (507) 261-2208\
Contact: Juan Jovane, Director

Ministerio de Comercio e Industrias\
Viceministerio de Comercio Exterior\
P.O. Box 61897 El Dorado, Panama\
Phone: (507) 236-0511\
Fax: (507) 236-0521\
E-mail: <vicomex@mici.gov.pa>\
Contact: Meliton Arrocha, Vice-Minister

Ministerio de Economia y Finanzas\
Direccion General de Aduanas\
P.O. Box 1671 Balboa, Ancon\
Phone: (507) 232-5355\
Fax: (507) 232-6494\
Contact: Mercedes Villalaz, Director

Ministerio de Salud\
P.O. Box 2048\
Panama 1, Panama\
Tel: (507) 225-6080\
Fax: (507) 227-5276\
Contact: Fernando Gracia, Minister

##### Trade Associations

American Chamber of Commerce & Industry of Panama (AMCHAM)\
P.O. Box 74, Balboa, Panama\
Phone: (507) 269-3881\
Fax: (507) 223-3508\
E-mail: <amcham@sinfo.net>\
Contact: David Hunt, Executive Director

Asociacion de Usuarios de la Zona Libre de Colon\
P.O. Box 3118 ZLC, Panama\
Phone: (507) 441-4878\
Fax: (507) 441-4347\
E-mail: <au@sinfo.net>\
Contact: Digna Donado, President

Panamanian Chamber of Commerce, Industry and Agriculture\
P.O. Box 74, Panama 1, Panama\
Phone: (507) 225-4615\
Fax: (507) 225-3653\
E-mail: <cciap@panama.phoenix.net>\
Contact: Jose Ramon Varela, Executive Director

Sindicato de Industriales de Panama\
P.O. Box 64798, El Dorado, Panama\
Phone: (507) 230-0284\
Fax: (507) 236-0166\
E-mail: <sip@sinfo.net>\
Contact: Daniel Vega, Executive Director

### *Source:* International Market Insight, *Commercial Opportunites for Used/Refurbished Medical Equipment in Panama*, 2 March 2002

#### Summary

Panama offers good opportunities for exporters of used/refurbished
medical equipment. Although government organizations by law cannot
acquire used equipment, there is a potential market in the private
sector, especially small to medium clinics and hospitals both in Panama
City and in the interior of the country. U.S. medical equipment has an
excellent reputation and is preferred by most doctors and hospitals.
There are no restrictions/regulations for importing used medical
equipment and import duties are relatively low. End Summary.

#### Body

The Ministry of Health manages the health care system in Panama. Along
with the Social Security System, it is responsible for procuring all of
the medical equipment in the public sector. Private hospitals and
clinics are the other main buyers of medical equipment in Panama.

There are no regulations, technical or safety standards applicable to
new and used medical equipment in Panama. Both U.S. standards and
European standards are accepted. Both used and new equipment is subject
to the same treatment. By law, public institutions cannot buy used or
refurbished equipment. The Panamanian international banking center
offers excellent facilities for international trade transactions. The
U.S. dollar is legal tender in Panama. No payment or exchange
restrictions exist.

In 1998 import duties for medical equipment were lowered to an average
of 10 percent, compared to the previous levels of up to 35 percent.
Import duties in Panama are assessed over the CIF value. Additionally, a
five percent value added tax is charged on the aggregate of the CIF
value plus the import duty. Product reputation, as well as quality and
service are the most important factors for end users when making a
purchase decision, followed by price.

There are good market opportunities for used/refurbished medical
equipment, especially in small hospitals and private hospitals both in
Panama City and in the interior of the country. Products in greatest
demand are imaging, x-ray, laboratory and diagnosis equipment.

For more information on Panama's health sector, please contact:

Ministerio de Salud\
PO Box 2048\
Panama 1, Panama\
Tel: 507-225-6080\
Fax: 507-227-5276\
Contact: Fernando Gracia, Minister

### *Source:* Report from CS Post (via Cable), 6 March 2000 {#source-report-from-cs-post-via-cable-6-march-2000 .unnumbered}

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

No special restrictions apply to used medical equipment in comparison to
new equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Public health institutions cannot buy used or refurbished equipment. By
law, the government can buy only new equipment.

*Is there a market for used or refurbished devices?*

There is a market for used and refurbished equipment.

*Best prospects?*

Best prospects are: diagnosis equipment, imaging equipment, X-ray
equipment.

## Paraguay

###### General Market Condition: No Restrictions, but Public Institutions Cannot Buy

### *Source:* Report from CS Post (via E-Mail), 25 April 2003

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

Paraguay has no special restrictions or tariffs that apply to used
equipment that do not apply to new medical equipment.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in used
/refurbished condition without the used device being subjected to new
safety inspections, etc.?*

Yes. Paraguay has no safety inspection requirements.

*Can public health institutions buy used or refurbished medical
devices?*

Public health government institutions cannot buy used or refurbished
medical devices.

*Is there a market for used or refurbished medical devices?*

There is a market for used and refurbished medical devices.

*What types of used or refurbished medical equipment are in the greatest
demand?*

Diagnostic imaging equipment is in the greatest demand.

## Peru

###### General Market Condition: Restricted in Practice not Law

### *Source:* Report from CS Post (via Cable), 5 April 2002

#### Summary

There is no explicit restriction on the importation of used/refurbished
medical equipment into Peru. However, as a matter of practice over
recent years, the Directorate General of Pharmaceuticals, Inputs and
Drugs (*Dirección General de Medicamentos, Insumos y Drogas*---DIGEMID)
of the Ministry of Health is not authorizing the import of used medical
equipment and devices.

By law, public health hospitals, social security hospitals and armed
forces hospitals can buy only new medical equipment and devices. Private
sector clinics and hospitals can purchase used medical equipment.

Imports of general used equipment are treated the same as imports of new
equipment. Under General Health Law No. 26842, imports of medical
equipment and devices require a 'Sanitary Registration' issued by
DIGEMID of the Ministry of Health. It is necessary to obtain the
Certificate to Foreign Governmen' from the U.S. Food and Drug
Administration (FDA) to be able to get the Sanitary Registration. The
inspection certificate issued by one of the three authorized companies,
i.e., SGS, COTECNA, and Bureau Veritas, is also required. These
companies charge US \$250 for imports valued from \$2,000 to \$25,000
and 1 percent for imports valued overr US \$25,000.

Both new and used products pay 7-percent or 12-percent custom duties
applicable on the CIF value, in addition to the 18-percent sales tax.

In addition, the Customs Circular 1071 dated September 16, 1999, states
that the Sanitary Registration is mandatory to release the products from
customs. However, as a matter of practice DIGEMID only issues the
Sanitary Registration for new medical equipment. The latter circular
only authorizes the import of used medical equipment when it is for the
immediate use by a professional returning to Peru.

## Philippines

###### General Market Condition: No Restrictions, but Public Institutions Cannot Buy

### *Source:* ISA Radiological Equipment, 21 August 2002 \[Extracts\]

#### Market Highlights and Best Prospects:

The average total market size of the radiology equipment market from
1999 to 2001 is approximately US\$13 million. Industry players project
that market demand will grow by fifteen percent in the next three years
due to hospital expansion, development of Department of Health projects
and population growth. Private hospitals in Metro Manila and its
suburbs, which have the financial resources for upgrading will drive
demand in this sector. Imports account for 98% of total radiology
equipment; prototypes and locally assembled equipment from surplus
materials account for the remaining 2%. Prototypes, however, are not
sold commercially and are used only in Department of Health equipment
laboratory tests and training centers.

There are locally produced equipment parts but their value is
insignificant. More often, it is cheaper to import parts from China than
to manufacture locally. France, Germany, the Netherlands and Hong Kong
also supply radiology equipment parts and accessories (high-tension
generators, control panels and desks, screens and examination tables).

The period of 1999 to 2001 also saw the completion of the much-touted
Asian Hospital in Alabang, Muntinlupa. The hospital is managed by the
Singapore-based Vista Healthcare Asia Pte. Ltd. GE Medical Systems, the
largest U.S. company in the medical business in the Philippines,
outfitted the Asian Hospital\'s various specialty departments. This
250-bed hospital showcases the best technology that U.S. companies can
offer -- from hospital design and administration, to healthcare service
delivery and medical/laboratory equipment. GE dealers also report that
they installed 12 out of the 17 X-ray machines in 2001---7 new equipment
and 5 refurbished---an accomplishment despite what many businessmen
considered \"hard times.\" There is a growing market for refurbished
medical equipment. Private hospitals and clinics outside metropolitan
Manila tend to purchase used/refurbished equipment, whether x-ray,
cardiology or surgery. To date, about 55% of all medical equipment
supplied to hospitals and clinics are refurbished, according to
equipment dealers.

#### D. Market Access:

The Philippines imposes a 3% tariff duty and a 10% value-added tax (VAT)
on imported medical equipment. The Bureau of Radiation Health Services,
Department of Health, requires that radiation emitting devices be
registered before introduction to the local market. Local testing is
required only for certain radiation equipment. There are no import
quotas for products in this sector, including used and refurbished
medical equipment.

### *Source:* Report from CS Post (via E-Mail), 1 July 2002

Medical Device Regulatory Requirements for the Philippines, July 1, 2002

There are no special restrictions on the importation of medical
equipment provided these are imported by duly authorized and licensed
medical equipment importers and distributors. Importers/Distributors
must secure this License to Operate (LTO) from the Department of Health.

The Bureau of Health Devices does not impose any restriction on used
medical equipment except that these should be comparable in safety with
new equipment. Refurbishers of used equipment must obtain a clearance
from the original equipment manufacturer and must conform to good
manufacturing practices. Refurbishers are also not allowed to distribute
commercially, any device that has not been produced in conformity with
such requirement.

Only X-ray machines and other radiation-emitting devices require
registration before introduction to the local market. Local testing is
required only for certain radiation equipment like the Linear
Accelerator.

The validity period for initial registration of a medical device is one
year. Under Bureau of Food & Drug Administration (BFAD) Circular #05,
series of 1998, length of renewal registrations has been extended to
five years.

The Bureau of Health Devices and Technology under the Department of
Health is the primary agency that monitors medical equipment (ionizing
and non-ionizing, radiation dosimetry, radiation, non-radiation,
laboratory, medical physics, etc.)

The Philippines imposes a 3-percent tariff duty and a 10-percent
value-added tax (VAT) on imported medical equipment, including used and
refurbished. As a policy, however, the government can only procure new
equipment.

The Department of Health or the health units under the local government
supervision may, however, accept used equipment if these are donated,
provided the equipment includes an operation manual to ensure its safe
operation. The government discourages Philippine importers from buying
used equipment without proper documentation and operation handbook.

There are good opportunities for used/refurbished medical equipment: it
accounts for 40 percent of the Philippine market. Like new equipment,
the most promising sub-sectors are X-ray equipment and medical/surgical
instruments. Major end-users are the primary and secondary hospitals in
Metro Manila and the provinces.

There are 3 classifications of Philippine hospitals:

-   Primary Hospitals---capable of handling general medicine,
    pediatrics, obstetrics and minor surgeries;

-   Secondary Hospitals---can handle all services available in a primary
    hospital including gynecology, general surgery, and other ancillary
    services;

-   Tertiary Hospitals---fully departmentalized hospitals that can
    handle more specialized services than secondary hospitals.

#### Contact Information

Department of Health of the Philippines:\
San Lazaro Compound, Tayuman, Sta. Cruz\
Manila, Philippines 1003

Website: www.doh.gov.ph/bfad

Organization E-mail: bfad@mc.pworld.net.ph

Telephone: (63-2) 743-8301; 711-6016\
Fax: (63-2) 711-6824

#### Contacts

Dr. Manuel Dayrit\
Secretary, Department of Health

Ms. Agnette P. Peralta\
Director, Bureau of Health Devices and Technology

Engineer Cecilia Matienzo\
Engineer V, Bureau of Health Devices and Technology

## Poland

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 28 March 2002

#### Import Regulations for Used Medical Equipmen in Poland Prepared by Zofia Sobiepanek

There are no restrictions in Poland on imports and/or the purchase of
used medical equipment by either state-owned or private health care
facilities, but market opportunities for second-hand equipment are very
limited. Used equipment purchases are made but no specific buying
pattern has been identified. Leasing of medical equipment is not wide
spread in Poland. Moreover, the market for used/refurbished medical
equipment is also very limited. However, with an increasing number of
private clinics and financial limitations within the public health care
sector their sales prospects might improve significantly in the next few
years.

Currently, the Polish government's policies are aimed at meeting
requirements for European Union (EU) membership. Polish authorities are
being pressured from many sources to adopt European Union standards and
to accept, without further testing, all products that are certified in
EU countries. However, at this time it is difficult to foresee when such
a policy change will be in effect. Therefore, one of the best strategies
for American companies interested in selling medical devices in Poland
is to find a local partner who can assist them in responding properly to
tender offers and with the existing procedures required to sell
equipment in Poland.

Because it is difficult to make a one-time sale of medical equipment,
Polish partners prefer to work with foreign suppliers on a long-term
basis. Price is also a key factor considered by potential buyers.
Important too is the local availability of services and spare parts.
Quality is usually the next element considered, and U.S. products are
usually viewed favorably.

In Poland, doctors recommend medical products. A good marketing strategy
is to keep them well informed about products. This means that a
successful company will need to have a distributor who can raise
awareness of new products, attend medical seminars and conferences, and
keep doctors informed by direct contacts or mail campaigns.

#### Registration/Certification

Currently, medical equipment, new and used, for use in public hospitals
and/or private clinics and medical centers must be certified by the
appropriate Polish authorities. Any equipment offered in public tenders
must have initiated the registration procedure in order to be permitted
to participate in a tender, and the procedure must be completed before
any contract is signed. It is crucial to have a Polish partner or
representative to assist with what is generally a complicated
certification process.

The certification requirement is regulated by the Minister of Health and
Social Welfare's Regulation on Certificates of Medical Apparatuses and
Equipment acquired by Health Care Institutions of March 11, 1992, which
can be found in government publication Dziennik Ustaw (Journal of Law),
Dz. U. 31/92 item 135.

A company registered in Poland must make the request for registration.
The applicant may be an authorized representative or a distributor of a
foreign supplier. All equipment is tested technically. If the producer
is not already known by the certification agency, or the equipment is
complicated, it may also require clinical tests. Certification is issued
for a period of five years with the possibility of extending it for
another three years. Medical equipment does not require additional tests
for the Polish 'B' safety certificate, which is required for many other
types of equipment.

American exporters should be aware that electrical voltage in Poland is
220 and the current frequency is 50 Hz. Power cables and plugs must be
consistent with Polish standards. Labeling and instructions for use
(operation manual) must be in Polish language. Technical documentation
and certificates as required for submission can be in one of the
following languages: English, German or French.

The following office is responsible for certification of medical
equipment:

Centralny Osrodek Techniki Medycznej\
(Central Medical Technology Center)\
ul. Boduena 4\
00-950 Warszawa, Poland\
Tel: +48/22 827-80-51 ext. 41\
Fax: +48/22 827-87-91\
Contact: Dr. Marian Nowicki, Chief, Certification Department (Kierownik
Biura Atestacji)

Once the new law on medical products is implemented (which is expected
to happen sometimes in 2002), the above regulations will no longer be in
force. The Healthcare Products Registration Agency will replace the
Central Medical Technology Center. Under the new law, most of the
regulations will be harmonized with the European Union's Medical Device
Directives. However, the CE mark will be accepted for Class I (low-risk)
products that do not need testing by a certified body in any country.
Since Poland will still operate as an independent market separate from
the EU, some local regulatory requirements will remain in place until
Poland becomes a full EU member. Manufacturers from third countries,
including the United States, will need to have their products tested and
certified by the Healthcare Products Registration Agency until Poland
joins the EU.

#### Tariffs

There are no differences in tariffs for new or used medical equipment.

Poland complies with the Harmonized Tariff System. Tariff rates are
subject to change annually (in January). Depending on the country of
origin, products are divided into three categories: developing nations,
members of the World Trade Organization, and countries with which Poland
has a bilateral or multilateral customs agreement (e.g., free trade
agreements, CEFTA). In 1992, Poland signed an Association Agreement with
the European Union (EU) that lowered or eliminated tariffs on many EU
produced goods imported into Poland. Tariffs on U.S. products did not
change. At that time, the U.S. managed to negotiate more favorable rates
for some product categories, but many U.S. products are still at a
tariff disadvantage compared to EU competitors. Customs rates (duties)
are based on the CIF value of the product. Customs officials are
extremely strict with regards to proper documentation. It is essential
that exporters take care to fill out documents properly to avoid costly
delays in customs clearance.

#### Tariff rates

Customs duties apply to all products imported into Poland. The Polish
tariff schedule has different rates for the same commodities depending
on their country of origin. Revisions to the Polish tariff rate schedule
are made annually. American companies generally face unfavorable customs
tariffs compared to imports from European countries. While the customs
tariff for medical equipment and supplies imported from the U.S. varies
from 3 percent to 9 percent, EU and EFTA equipment is completely
exempted from customs duty.

In addition to the above tariffs, a value-added tax (VAT) of 22 percent
is added regardless of origin.

#### Best Sales Prospects

The current Polish health care system operates on the basis of dual
financing. The owners of public hospitals and clinics, the local
governments, finance major investments such as equipment purchases,
construction and maintenance of the facilities. The Sick Funds are
responsible for financing the operating costs of the health care system
in Poland, i.e. the daily costs of the primary care, outpatient and
in-patient care, as well as reimbursement for medicines and
rehabilitation products. The Sick Funds operate on the actual, current
contributions of employers and employees. The Ministry of Health
directly finances clinical academies and research hospitals and
specialist institutes, and prepares and is responsible for healthcare
education.

Poland's budgetary constraints heavily influence the public health
sector. In year 2000, Poland spent 4.24 percent of GDP on health care.
Healthcare costs accounted for 4.3 million PLN (about 1 million USD),
which represents 2.85 percent of the state budget. Local governments
spent 2.7 million PLN (about 675 thousand USD), which represents 3.6
percent of their annual budgets. The main healthcare payers, Sick Funds,
spent 23.8 million PLN (about 6 million USD) in 2000.

Private clinics can purchase medical equipment independently from any
source they wish or through any trading organization they choose.
Privatization of healthcare services in Poland has proceeded most
rapidly in ambulatory and diagnostic imaging services and outpatient
care. There are a great number of small private outpatient clinics
providing one-day-surgery, cosmetic surgery, medical check-ups, lab
tests, etc., where patients pay either out of their own pocket or
through private health care packages offered by major companies as a
fringe benefit to their employees.

The U.S. Commercial Service (CS) Warsaw has identified the following
best prospects in medical equipment sector for the Polish market:

-   Ultrasonography equipment

-   Endoscopy equipment

-   Hospital sterilization equipment

-   Monitoring equipment for use in intensive care

-   Emergency medicine

-   Oxygen therapy

In addition to the above-listed categories, rehabilitation equipment is
also a good prospect for U.S. suppliers. Access to most private and
public buildings and to public transportation is still a serious
problem. There is a critical need to reduce physical barriers in order
to enable disabled people to live better lives and to function more
easily in society. Also, there is a demand for high quality home-care
products and accessories.

Investment type purchases, such as advanced medical equipment like
mammography equipment, EEG equipment, Magnetic Resonance Imaging units,
radiography/tomography Units, X-ray equipment, etc., are currently
extremely limited.

#### Additional Information

For further information regarding medical sector in Poland, please
contact the U.S. Commercial Service, American Embassy Warsaw, Poland. We
offer a wide range of programs to open the Polish market to Amercian
companies. For more information about what we do and how we do it,
please take a look at our website:
[www.buyusa.org/Poland](http://www.CSCentralEurope.org/Poland) (it will
come up in Polish, but you can click on the English version).

**Mailing address (from the U.S.):\
**5010 Warsaw Place\
U.S. Department of State/FCS\
Washington, DC 20521-5010

**Street address:\
**U.S. Commercial Service\
Al. Jerozolimskie 56 C\
00‑803 Warsaw, Poland\
Tel:+48/22 625-4374\
Fax: +48/22 621‑6327\
Contact person: Zofia Sobiepanek, Commercial Specialist\
e-mail: <Zofia.Sobiepanek@mail.doc.gov>

### *Source:* Industry Sector Analysis, *Medical Device Payment/Reimbursement*, 29 March 2002

Leasing of medical equipment is not wide spread in Poland. Moreover, the
market for used/refurbished medical equipment is also very limited.
However, with an increasing number of private clinics and financial
limitations within the public healthcare sector, their sales prospects
might improve significantly in the next few years.

Currently, medical equipment, new and used, for use in public hospitals
and/or private clinics and medical centers must be certified by the
appropriate Polish authorities. Any equipment offered in public tenders
must have initiated the registration procedure in order to be permitted
to participate in a tender, and the procedure must be completed before
any contract is signed. It is crucial to have a Polish partner or
representative to assist with what is generally a complicated
certification process.

## Portugal

###### No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 22 April 2003

Portugal is governed by the EU harmonized legislation/directive which
covers the importation of new and used medical devices to Europe. The
importation of new and used medical equipment for use in Portuguese
public hospitals and/or private clinics and medical centers must be
certified by the appropriate Portuguese authorities. These devices, when
imported from third countries to be sold in Portugal, have to undergo a
complicated certification process by a credited entity in the EU. If
devices pass this certification, they are marked 'CE' and may move
freely and be sold in all countries in the EU.

This EU directive primarily focuses on certain minimum requirements for
the medical devices entering Portugal. All credited organizations are
attributed a 4 digit identifying code by the European Commission. In
Portugal, the official entity that is credited to attribute the CE mark
is:

LEMES-Laboratorio de Ensaios e Metrologia da Saude\
Av. Padre Cruz\
1600-560 Lisboa\
Tel: (351-21) 757-5853 / 757-3557\
Fax: (351-21) 757-3671\
Contact: Eng. Faria Gomes, President

Import duties are equally applied to new and used medical equipment,
these vary between 0 and 7.5 percent when entering from third countries
and 0 percent when of EU origin. Once cleared by customs in any one EU
country, goods may move free of duty within the EU. A Value-Added Tax
(19 percent) is applied ad valorem to all goods entering Portugal.

## Romania

###### General Market Condition: No Restrictions, but Public Institutions Cannot Buy with State-Guaranteed Loans

### *Source:* Report from CS Post (via E-Mail), 28 February 2002 {#source-report-from-cs-post-via-e-mail-28-february-2002 .unnumbered}

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

Customs tariffs for used equipment are similar to the ones for new
equipment

The Ministry of Health and Family (Ministerului Sanatatii si
Familiei---MSF) does not acquire refurbished medical devices through
sovereign guarantees

The refurbishment program applies to the existing pieces of equipment
already operational on the Romanian market

*Can public health institutions buy used or refurbished Medical
devices?*

MSF is not allowed to make purchases in a centralized manner based on
state guaranteed loans.

*Is there a market for used of refurbished devices?*

In Romania there is a market for used or refubished medical devices, but
this is currently not well-defined.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

As the size of this market has not been determined yet, it is difficult
to establish its structure. Checking up on the private market of medical
services may be beneficial although it is unlikely that a relevant
database might exist.

## Russia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 11 April 2003

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no special restrictions or tariffs that apply to used
equipment. The tariffs apply to the product category and are the same
for new and used medical equipment and devices, which belong to the same
category. The most common tariff for medical equipment is 5 percent.
There are only a few exceptions to this tariff rate. All disposable
syringes (except for those used to inject insulin), IV solution
transfusion systems, and hydro massage bath tubs are all subject to a
15-percent tariff.

*If a manufacturer or its special agent registered a medical device in
the country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc.?*

If the manufacturer or its agent had registered a medical device when it
was new in Russia, a third party can legally import the same device in
used/refurbished condition if it has a valid registration certificate
from the Ministry of Health. If the term of certificate has expired, it
should be renewed. In addition to the Ministry of Health registration a
third party should obtain a special certificate of conformity with the
Russian safety and quality standards issued by the State Standards
Committee. The duration of such certificate is from one to three years.

*Can public health institutions buy used or refurbished medical
devices?*

As a rule, Public Healthcare Institutions do not buy refurbished medical
equipment directly. Generally procurement of Public Health Institutions
is arranged by Regional Health Authorities responsible for procurement
of medical equipment in their respective regions. These authorities who
control the healthcare expenditures in the region are not interested in
buying used medical equipment, they prefer to buy brand new medical
equipment as they receive a percentage of the purchase price as a
reverse commission on the transaction.

*Is there a market for used or refurbished devices? Best prospects?*

The market for refurbished medical equipment is very limited. For years
Russian health care priorities have focused more on high technology
"cutting edge" medical products than on preventive medicine and basic
medical needs. As mentioned above, regional Health Authorities are not
interested in purchases of used/refurbished equipment for their
territorial hospitals.

Another obstacle, which diminishes incentives for purchasing used
medical equipment, is a lack of servicing and maintenance support from
the foreign suppliers of such equipment. As servicing and maintenance of
used medical equipment is crucial for successful sales and application
in clinics and hospitals, distributors are not interested in working
with such equipment unless the foreign dealers of used medical equipment
in cooperation with manufacturers of such equipment establish servicing
centers in Russia. Such centers should be supported by the manufacturers
supplying them with spare parts and arranging maintenance

According to our estimate, used medical equipment accounts for only 3
percent of the total medical equipment market.

*What type of used or refurbished medical equipment are in the greatest
demand?*

The best prospects for used equipment include X-ray equipment, magnetic
resonance imaging, ultrasonic and laboratory diagnostic equipment.

### *Source:* Report from CS Post (via E-Mail), 26 March 2002

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no special restrictions or tariffs that apply to used
equipment. The most common tariff for medical equipment is 5 percent.
There are only a few exceptions to that tariff rate. They concern
imported disposable syringes, except for ones used to inject insulin (15
percent), IV solution transfusion systems (15 percent) and hydro massage
bath tubs. The tariffs apply to the product category and are the same
for new and used medical equipment and devices, which belong to the same
category.

*Can public health institutions buy used or refurbished medical
devices?*

Public Health Institutions can buy used medical equipment, but it is not
in large demand as far as we can judge. Please note that Russian
distributors and healthcare institutes can only buy used medical
equipment which was registered by the Ministry of Health and certified
by Gosstandart when the equipment was new. The Ministry of Health will
only consider new medical equipment for registration. Subsequently, only
medical equipment that has been registered can be resold as used.

*Is there a market for used or refurbished devices? Best prospects?*

The market for refurbished medical equipment is very limited. Russian
health care priorities have focused more on high technology 'cutting
edge' medical products than on preventive medicine and basic medical
needs. Regional health authorities responsible for procurement of
medical equipment in their respective regions prefer to buy brand new
medical equipment as they receive a percentage of the purchase price as
a reverse commission on the transaction. According to our estimate, used
medical equipment accounts for only 5 percent of the total medical
equipment market. Refurbished medical equipment is usually handled by
private medical equipment distributors, which work directly with clinics
and hospitals.

*What type of used or refurbished medical equipment are in the greatest
demand?*

The best prospects for used equipment include X-ray equipment, magnetic
resonance imaging, ultrasonic and laboratory diagnostic equipment.

### *Source:* IMI Medical, 23 May 2001

#### Summary

Russia would appear to have the potential to sustain a healthy market
for used medical equipment, particularly for equipment used in the
manufacture of pharmaceuticals. Domestic Russian pharmaceuticals
manufacturers are currently enjoying very favorable market conditions.
To date, however, sales of imported used medical equipment have proved
disappointingly small. The difficulty of meeting the mandatory
registration and certification requirements, in a system not geared to
deal with foreign-source used equipment, acts as a constraint. So too
does the fragmented structure of the used market and the lack of
servicing support from foreign suppliers. These difficulties need not be
insurmountable, and Russia has an abundance of inexpensive, skilled and
easily trained technicians able to support medical equipment
refurbishing and assembling operations.

#### Body

The Russian market possesses many of the characteristics which should
make it attractive to suppliers of used medical equipment. It has a
large population (145 million), many of whom are aged. The state
healthcare system suffers significant budgetary constraints, and is
limited in its ability to purchase expensive new equipment. Local
equipment manufacturers have made few technological advances over the
last decade and consequently cannot offer the most advanced equipment.

The total size of the Russian medical equipment and supplies market is
currently estimated at about US \$2 billion, and has been growing
rapidly. Since the August 1998 economic crisis, this growth has exceeded
even the robust rates of growth of the Russian pharmaceuticals market.
However, the market for used medical equipment has proved disappointing
to date. According to the author's estimate, based on consultations with
industry experts and distributors, used equipment accounts for only 5
percent of the total market for medical equipment.

The market for refurbished medical equipment is very limited. While
public health institutions and the many regional health authorities are
permitted to buy imported used medical equipment, they usually prefer to
focus on new and often expensive 'cutting edge' technology. It has even
been reported that, in some cases, the desire by procurement staff to
receive informal incentive payments from suppliers may have driven the
decision to purchase such equipment. Equipment for use in the provision
of basic and preventative medicine is typically procured from local
manufacturers.

The mandatory registration and certification requirements for imported
equipment are not geared to used equipment and can be difficult, if not
impossible, to satisfy. Russian distributors and healthcare institutes
are permitted to purchase only used medical equipment which has been
registered by the Ministry of Health and certified by Gosstandart, the
Russian state standards agency. The Ministry of Health will register
only new medical equipment, not refurbished equipment. This means that,
if a certain make and model of new medical equipment has been registered
previously, then refurbished models may be sold. Otherwise the used
equipment cannot be sold in the Russian market. As for certificates of
conformity, such certificates can be obtained from certification centers
accredited by Gosstandart. With regard to customs regulations, there are
no special restrictions or tariffs that apply to used equipment, once it
is certified. The tariffs apply to the product category and do not
differentiate between new and used medical equipment and devices, with
the most common tariff for medical equipment being 5 percent.

The steep devaluation in the ruble in the aftermath of the August 1998
economic crisis made imports more expensive and resulted in the
increased competitiveness of Russian manufacturing industry. Russian
pharmaceutical equipment manufacturers have managed to compete against
imports in a period when their customers, the Russian pharmaceutical
companies, were similarly enjoying enhanced competitiveness. In 2000
alone, local pharmaceutical production increased by 20 percent and today
local manufacturers supply over 45 percent of the total market, taking
advantage of the sharp rise in prices of imported Western drugs. Many
Russian pharmaceutical factories are in need of new and replacement
equipment, including packaging and labeling equipment, and it is in this
area that some reasonable sales prospects exist for foreign suppliers of
used pharmaceutical manufacturing equipment. The Commercial Service
works with the Russian Association of Pharmaceutical and Medical
Equipment located in St. Petersburg to collects leads from Russian
pharmaceutical manufacturers for foreign reconditioned production
equipment.

In the case of used medical equipment for disease treatment, maintaining
and servicing such equipment in Russia is problematic. Even though local
labor costs are low, and the supply of proficient and trainable
technicians abundant, the cost of new replacement parts and components
can be prohibitively high. As a rule, local companies specializing in
refurbishing used medical equipment have to buy new spare parts from the
original manufacturer, as such parts are not produced locally. In some
cases, the price of a replacement part can be higher than the purchase
price of the used equipment itself. The problem is often compounded by
the absence of long-term, direct relations between foreign suppliers and
local medical equipment refurbishers. Shipments in the past have tended
to be infrequent and were typically handled through intermediaries
lacking the capability to provide adequate servicing and maintenance
support. In some cases, Russian buyers of used medical equipment
sustained losses as many spare parts were not available, and
consequently the equipment was impossible to refurbish. The above
problems not withstanding, the best prospects for used equipment in this
area include X-ray equipment, magnetic resonance imaging, ultrasonic and
laboratory diagnostic equipment.

Because labor costs in Russia are much lower than in the West, several
companies have found it cost effective to assemble equipment locally
from imported components, rather than import finished product. A
significant portion of production equipment for the pharmaceutical
industry is assembled locally. The leading Russian company which
specializes in refurbishing and maintaining used Western medical
equipment is Izomed. This firm is seeking to establishing long-term
cooperation with Western manufacturers based on at least a 6-month
warranty period and servicing contracts. Another organization which is
interested in cooperation with Western suppliers of refurbished medical
equipment is the newly created Soyuzmedprom Association, which unites
major Russian manufacturers and distributors of medical equipment.

It is not inconceivable that a well organized and well financed used
medical equipment supplier could overcome the obstacles currently a
feature of the Russian market to emerge successful, or that niche
players might find profitable roles for themselves. At present, however,
the current market structure and regulatory environment are not
favorable for the others.

This information is provided to you by the Commercial Service (CS) in
Moscow, part of the U.S. Embassy, which offers to U.S. exporters a
number of services aimed at generating export sales, including
identifying distributors and arranging meetings with prospective buyers
during business visits to Russia. The CS Moscow, encourages U.S.
companies wishing to do business in Russia to utilize its [Gold Key
Service.]{.underline} Experienced Commercial Specialists identify
opportunities, arrange business appointments with pre-qualified Russian
agents and distributors, and accompany you to the meetings. Gold Keys
cost \$600 (basic prices) or \$1,200 (full logistical support price) for
a full day of appointments (typically 4), and \$300 (basic price) and
\$630 per additional day. Logistical support includes assistance with
reservations at suitable hotels, several of which provide discounted
rates to CS clients; airport pick-up/drop-off; ground transportation to
meetings; and interpreter services for 8 hours a day. The Commercial
Service requires sufficient company literature and price lists at least
three weeks prior to the desired appointment dates, and accepts payment
by VISA, MasterCard, American Express and Discovery cards. Additionally,
as part of CS' regional cooperation program, CS Moscow will share your
Gold Key inquiry with other offices, who may contact you directly. For
more information on FCS Moscow services, U.S. companies may visit our
website at: www.usatrade.gov or the BISNIS site at:
[www.bisnis.doc.gov]{.underline} or contact us directly.

Ludmila Maksimova, Commercial Specialist\
FCS/U.S. Embassy Moscow\
U.S. Department of Commerce\
Tel: 7-095-737-5037/5030\
Fax: 7-095-737-5033\
E-mail: Ludmila.Maksimova@mail.doc.gov

### *Source:* International Market Insight, *Healthcare Services, Medical Equipment and Supplies, and Pharmaceuticals Market in the Russian Far East*, 22 March 2001

Dental equipment and supplies are in growing demand on the local market.
The poor fluorite level in local water and tough climate conditions
presuppose a larger than average need for dental services in Russia. All
dental equipment and supplies are imported. At the same time, dental
clinics are usually private, market-oriented and profitable. The
combination of these factors makes this subsector rather attractive for
U.S. exporters.

Despite an obvious under-financing of this subsector \[dental\], used
and second-hand medical equipment have very limited sales potential on
the Russian Far East (RFE) market due to certification and other
administrative impediments.

There is some potential though for pharmaceuticals' manufacturing
equipment.

### *Source:* ISA Medical, 1 January 2000

#### Home Healthcare Products and Equipment: Best Sales Prospects

In general, the Russian population and health care and social protection
authorities prefer to buy new home healthcare products and equipment,
therefore, used products and equipment are not in high demand.

### *Source:* ISA Medical and Dental, 1 March 1999 {#source-isa-medical-and-dental-1-march-1999 .unnumbered}

#### Best Sales Prospects {#best-sales-prospects-2 .unnumbered}

Because many types of dental equipment and supplies, which are needed
for treatment, are not produced locally, there will be unsatisfied
demand for many types of products for the next three years. According to
data provided by the Russian Dental Association, the best sales
prospects in the Russian dental equipment and supplies market include:

+-----------------------------------+-----------------------------------+
| -   dental units                  | -   adhesive systems              |
+-----------------------------------+-----------------------------------+
| -   dental X-ray equipment        | -   photopolimerizers             |
+-----------------------------------+-----------------------------------+
| -   pastes for filling root       | -   dental disposable supplies    |
|     canals                        |                                   |
+-----------------------------------+-----------------------------------+
| -   equipment for dental          | -   dental anaesthetic gels &     |
|     orthopedics                   |     solutions                     |
+-----------------------------------+-----------------------------------+
| -   dental porcelains             | -   anchorage pin systems         |
+-----------------------------------+-----------------------------------+
| -   dental films and chemicals    | -   composite filling materials   |
+-----------------------------------+-----------------------------------+

In general, Russian dental clinics prefer to buy only new dental
equipment therefore used dental equipment is not in high demand.

## Saudi Arabia

###### General Market Condition: No Restrictions, but Ministry of Health and Government Hospitals Do Not Purchase

### *Source:* Report from CS Post (via Cable), 9 September 1998

There are no Saudi standards nor any specifications that apply to used
or refurbished medical equipment. The Ministry of Health and other Saudi
government hospitals will, however, abstain from purchasing such
equipment. Other clinics and hospitals might purchase the same only from
an established local agent who should be able to provide maintenance and
spare parts for 10 years. The only standard that applies relates to
electrical specifications, i.e. 110 V, 60 Hz.

## Serbia and Montenegro

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 23 July 1998

The Former Republic of Yugoslavia (FRY) permits the importation of used
equipment other than vehicles and construction equipment. Tariffs are
generally the same or slightly higher than for new equipment of the same
type. Vehicles equipped with medical equipment may be imported if they
are not more than 4 years old.

The used equipment market in the FRY is relatively new and undeveloped.
Most large firms are socially owned and appear to be adverse to
purchases of used equipment. Reports indicate that price is often not
the primary criterion for decision makers of such firms. Smaller firms
appear to have some interest in used equipment, but face bureaucratic
hurdles and possess low purchasing power. The Serbian government
recently decided to prohibit imports of used clothing, which was
beginning to gain a foothold in the FRY. This ban sends a cautionary
signal about prospects for significant development of the used equipment
market, although the ban may be an isolated case since it was part of a
set of actions taken to reduce imports of consumer goods.

## Senegal

###### General Market Condition: No Restrictions, but Public Institutions Do Not Buy

### *Source:* Report from CS Post (via Cable), 6 April 2001

The market for used/refurbished medical equipment in Senegal is very
limited, if not non-existent. In a country where the public sector is
the biggest purchaser and user of medical equipment, major impediments
to the sale of used medical equipment remain, due to public procurement
procedures and to technical constraints.

In the public sector, all purchases of medical equipment are made either
through international tenders financed by the World Bank and other
multilateral donors or they are financed by the Senegalese government's
special investment budget. A stringent requirement is that the equipment
be new.

The technical constraints essentially concern the norms and standards.
The Senegalese market is based on European standards: 50 cycles, 220
volts. Professionals in the sector report that sophisticated medical
equipment, such as imaging equipment, radiography and echography that
use the standard u.s. 110 volts, is degraded when stepped-up to 220
volts. Further, all documentation and training need to be available in
French. The availability of spare parts and a technically qualified
agent to deliver after-sales service are critical to achieving success
in the market.

The private sector market consists of private clinics and practices
almost exclusively based in the Dakar area. This market segment does not
have the same restrictions as the public sector, therefore used/
refurbished equipment could find acceptance here. However, the
acceptance to date is somewhat limited. The importers contacted during
this research mentioned that used equipment might have an image problem
to overcome. The equipment is already perceived as old and there might
be concern regarding its reliability and the availability of spare
parts. Therefore, those importers rarely import used medical equipment.
Some private purchases are done directly by the private clinics.

There are no government regulations barring the import of used medical
equipment. As with other imports, used medical equipment is subject to
import duties and taxes.

#### Key contacts

##### Government

Ministry of Health Building Administratif Dakar\
Tel: 221-821-50-48\
Minister: Mr. Abdou Fall\
Agetip Boulevard\
Djily Mbaye Dakar\
Tel: 839-02-02\
M. Maguette Wade, Director\
Agetip is a world bank-funded agency. Agetip monitors public tenders for
medical equipment.

##### Major Importers

  ----------------------------------- -----------------------------------
  Technologies Services\              Delta Medical\
  Rue Aime Cesaire - Fann Residence\  57, Rue Mousse Diop\
  B. P. 5249\                         B. P. 7020\
  Dakar\                              Dakar\
  Tel: (221) 825-0404\                Tel: (221) 822-3037\
  Fax: (221) 825-8183\                Fax: (221) 821-1027\
  Mobil: (221) 638-5338\              Dr. Sammy Hannouche, Director
  E-Mail: Techserv@Telecomplus.Sn\    
  Mrs. Dedee Dieynaba Ba, Director    

  Boulch Electronics\                 Cadecur\
  140, Rue Mousse Diop\               Rue 11 X F, Point E - Zone B\
  B. P. 1564\                         Imm. Hadjjar\
  Dakar\                              B. P. 5012\
  Tel: (221) 822-1643 / 822-1843\     Dakar\
  Fax: (221) 822-9726\                Tel: (221) 825-3532\
  Mr. Jean-Marie Boulch, Director     Fax: (221) 822-0702 / 821-1929\
                                      Mr. Claude Blain, Director

  Certec Equipements\                 La Maison Du Medecin\
  36, Rue V. Hugo X J. Gomis\         Rue Vincens\
  B. P. 11275\                        Dakar\
  Dakar\                              Tel: (221) 822-5002\
  Tel: (221) 822-0517\                Fax: (221) 822-1360\
  Fax: (221) 821-5319\                Mr. Barro, Director
  E-Mail: Certec@Sonatel.Senet.Net\   
  Mr. Abdourahmane Ndoye, Director    

  Materiel Hospitalier\               Fermon Distribution\
  8, Boulevard De La Republique\      96, Rue Carnot\
  B. P. 179\                          Dakar\
  Dakar\                              Tel/Fax: (221) 821-6764\
  Tel: (221) 821-5363\                Mrs. Cecile Khadige Akar, Manager
  Fax: (221) 822-5883\                
  Mr. Henri Urbain, Director          

  Adansonia\                          Sodemed\
  31 Rue Abdou Karim Bourgi\          10, Boulevard De L'est X Rue 2\
  B. P. 200\                          Point E\
  Dakar\                              B. P. 2170 Dakar\
  Tel/Fax: (221) 822-0922\            Tel: (221) 825-0808 / 825-0040\
  Mr. Bara Diop, Manager              Fax: (221) 824-6005\
                                      E-Mail: Sodemd@Sentoo.Sn\
                                      M. Ndongo Ndoye, Director.\
                                      Elam-Thomas
  ----------------------------------- -----------------------------------

## Singapore

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 13 March 2001 (Confirmed as still valid, 4 March 2002)

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no restrictions or tariffs levied on new or used medical
equipment. Singapore is generally a free trade port and an open economy.
However, a 3.0-percent goods and services tax (GST) is imposed on goods
sold and services locally provided. Imports are subject to GST but
payments are refundable on re-exports.

*Can public health institutions buy used or refurbished Medical
devices?*

Yes, public health institutions can buy used and refurbished medical
devices. However, the public hospitals prefer to purchase new medical
devices.

*Is there a market for used of refurbished devices?*

The general view is that there is no market for used or refurbished
medical devices for the Singapore market as the general preference is
for new medical devices.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

As stated above, there is no market for refurbished products.

## Slovenia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 25 March 2002

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

The regulations for the import of medical equipment are prescribed in
the Official Gazette, issues 101/1999 and 82/2000. There are no special
restrictions or tariffs that would apply to the imports of used medical
equipment. The import regime is the same as it is for the import of new
medical equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Public health institutions can buy used or refurbished, but do not
choose to do so.

*Is there a market for used or refurbished medical devices?*

According to previous experiences of several U.S. companies trying to
sell refurbished X-ray systems in the region about two years ago, there
is (almost) no market in the country for the refurbished products.
According to an industry source, the mentality of Slovenian doctors
mentality is against refurbished products. Also, all hospitals are
state-owned with the exception of a couple of recently built small
medical sanatoriums for wealthy people.

## South Africa

###### General Market Condition: Restricted

### *Source:* Policy Statement issued by the South African Department of Health, Directorate of Radiation Control

#### Requirements with regard to Application for a Licence to Sell any Listed Electromedical Product Hazardous Substances Act, 1973 (Act 15 of 1973)

The primary responsibility and concern of the Directorate: Radiation
Control, as part of the Department of Health, is the **safety** of the
South African public, and especially the safety of the patient where
listed electromedical products are concerned. The aim of the
Directorate: Radiation Control is to establish a situation where
patients can have reasonable assurance that any listed electromedical
product that is used in a medical application, complies with a set of
**minimum requirements** with respect to safety and performance. In
specifying these requirements it is the express intention of the
Directorate: Radiation Control to see to it that an unbroken and
effective **line of communication** between the manufacturer of a
particular product and the end user of that product is established and
maintained. **These minimum requirements apply to the sale of all listed
electromedical products, i.e. new, refurbished, and other pre-owned**,
and are as follows:

A dealer wishing to sell any listed electromedical product on the South
African market has to apply for a licence in terms of the Hazardous
Substances Act, 1973 (Act 15 of 1973) by submitting a completed
application form for **each model** to the Directorate: Radiation
Control;

**and**

i\) [In the case of **new** products]{.underline}:

> At least one of the procedures mentioned under Annexure A must be
> followed. If the manufacturer is not represented directly in South
> Africa, a copy of the letter is required in which the manufacturer
> states that this particular dealer in South Africa, applying for a
> licence for sale, is an authorised agent of that manufacturer in South
> Africa.

ii\) [In the case of **refurbished** products]{.underline}:

> A copy of the **letter** is required in which the refurbisher states
> that this particular dealer in South Africa, who is applying for a
> licence for sale, is an **authorised** agent of that refurbisher in
> South Africa.
>
> a\) **If** the dealer chooses to follow the **FDA 510(k) procedure**
> (see **Annexure A**), the following is required:

-   Copy of the 510(k) letter covering the original product.

-   Letter from the original manufacturer stating that the refurbisher
    has been authorised by the original manufacturer to carry out
    refurbishing of a particular model, and that the original
    manufacturer undertakes to supply the refurbisher with replacement
    parts, upgrades, service bulletins, and hazard reports pertaining to
    that particular model.

-   Letter from the refurbisher stating that the refurbished product is
    assembled to and match the original manufacturer's specifications
    for that particular model.

    b\) **If** the local dealer chooses to follow the **EC Declaration
    of Conformity procedure** (see **Annexure A**), the following is
    required:

-   Copy of the EC Declaration of Conformity by the **refurbisher** of
    that particular model, and a copy of the relevant certificate(s)
    issued by the Notified Body in terms of the Council Directives
    93/42/EEC or 90/385/EEC.

    c\) In the case of all other **pre-owned** products:

    **The importation of any pre-owned product that has not been
    refurbished is not permitted,** unless such a product is to be
    refurbished in South Africa and then offered for sale. In this case
    the requirements for refurbished products apply (see (ii) above).
    **Only** pre-owned products that were used **within** South Africa
    previously, can be resold by a dealer without having been
    refurbished.

    A dealer wishing to sell any such pre-owned product in South Africa
    must comply with the following requirements **when applying for a
    licence to sell that product**:

-   Submit a copy of the letter in which the original manufacturer
    undertakes to supply this particular dealer in South Africa with
    replacement parts, upgrades, and hazard reports pertaining to a
    particular model.

-   Submit **for each unit sold** a copy of the document which verifies
    the date on which that unit was acquired as new. (This will be a
    condition of the licence for sale for a particular model).

-   Obtain the full service record (i.e. since new) **of each unit
    sold**, preferably completed by the manufacturer or his/her
    authorised agent in South Africa, and pass this service record on to
    the purchaser of that particular unit. (This will be a condition of
    the licence for sale for a particular model).

#### Annexure A {#annexure-a .unnumbered}

1\. EC Declaration of Conformity procedure

A copy of the **manufacturer's Declaration of Conformity** is required
in which it is stated that a particular model complies with all the
applicable provisions (including the Essential Requirements in Annex I)
of the Council Directive **93/42/EEC** \[Medical Devices Directive
(MDD)\] or the Council Directive **90/385/EEC** \[Active Implantable
Medical Devices Directive (AIMD)\]. The certificate issued by a Notified
Body, designated as such by a Member State of the European Union,
enables the manufacturer to draw up this **Declaration of Conformity**
in which he/she solemnly states that the device complies with the
provisions of the MDD 93/42/EEC or AIMD 90/385/EEC. A Copy of the
relevant certificate issued by a Notified Body is required in addition
to the manufacturer's Declaration of Conformity. Compliance with the MDD
93/42/EEC has been compulsory for all medical devices sold within the
European Union since 14 June 1998 (Norway, Iceland, Liechtenstein and
Switzerland are not members of the EU). If, in the case of systems such
as X-ray installations, all the individual components already bear CE
marking in terms of MDD 93/42/EEC, the person placing such a system on
the market shall draw up a declaration in which the mutual compatibility
of the components are verified. If not, the system is treated as a new
device and an EC Declaration of Conformity has to be drawn up for the
system as a whole.

2\. FDA 510(k) procedure

A copy is required of either the **510(k)** or **PMA** letter in which
approval is given by the FDA to market a particular model in the USA.
Thus, if an electromedical device is being sold within the USA, the
manufacturer will have in his/her possession at least 510(k) letter from
the FDA authorising the sale of that particular model. If a device is
classified as Class III by the FDA, a PMA (Pre-market Approval) letter
must be issued before such a device can be offered for sale in the USA.

According to the FDA the manufacturer is best qualified to determine if
a proposed device change or modification would warrant submission of a
new 510(k) notification. If a manufacturer decides not to submit a new
510(k) notification, a record has to be kept of the reasons for not
doing so. In the case of a product that is listed in terms of the
Hazardous Substances Act, 1973 a copy of the appropriate **existing**
510(k) is required as well as the document containing the **reason(s)**
for not submitting a new 510(k).

### Schedule of Listed Electronic Products {#schedule-of-listed-electronic-products .unnumbered}

***Hazardous Substances Act, No. 15 of 1973\
Regulation No. R. 1302, 14 June 1991***

**1 Any electronic product generating X-rays or other ionizing beams,
electrons, neutrons or other particle radiation, namely-**

1 any diagnostic X-ray unit, including medical, dental and veterinary
units;

2 any therapeutic X-ray unit;

3 any X-ray unit used for industrial, research, educational, security or
any other purposes;

4 any electron accelerator;

5 any heavy particle accelerator;

6 any neutron generator;

7 any electron microscope;

8 any visual display unit, including any television receiving apparatus
and video display monitoring system, that employs a cathode ray tube
with an accelerating voltage exceeding 15kV; and

9 any cold cathode gas discharge tube producing X-rays, including those
for teaching of X-ray principles and high voltage switchgear.

**2 Any electronic product generating electromagnetic radiation in the
ultraviolet region, namely**

1 any sunlamp designed for the tanning of the skin of a human being;

2 any therapeutic lamp;

3 any high-intensity mercury-vapour discharge lamp;

4 any intra-oral curing device; and

5 any ultraviolet A lamp, including 'black lights'.

**3 Any electronic product emitting coherent electromagnetic radiation
produced by stimulated emission, namely all laser products that emit
radiation in excess of 0,8 x 10-9 watt in the wavelength region up to
and including 400 nm or that emit radiation in excess of 0,39 x 10-6
watt in the wavelength region greater than 400 nm.**

**4 Any electronic product emitting electromagnetic radiation in the
infra-red region, namely -**

1 any industrial heating and drying lamp installation exceeding 200
watt; and

2 any medical heating lamp exceeding 200 watt.

**5 Any electronic product emitting microwaves, radio or low frequency
electro­magnetic radiation, namely-**

1 any microwave oven;

2 any microwave diathermy unit;

3 any shortwave diathermy unit;

4 any electrosurgical unit;

5 any neuro-muscular stimulator;

6 any medical magnetic stimulator;

7 any radio-frequency generating device, system or installation,
including radars, generating a radio-frequency output exceeding 200 watt
RMS;

8 any low power radio-frequency generating device, system or
installation, including citizen band radios, land mobile transmitters,
marine transmitters and two-way (walkie talkie) radios, where normal
operation entails close proximity to the operator or third parties and
generating a radio-frequency output exceeding 25 watt RMS;

9 any microwave generating device, system or installation, including
radars, generating a microwave output exceeding 400 watt RMS ;

10 any radio-frequency sealer;

11 any magnetic resonance imaging device; and

12 any blood warmer.

**6 Any electronic product emitting ultrasonic vibrations, namely-**

1 any diagnostic ultrasound appliance;

2 any therapeutic ultrasound appliance;

3 any surgical ultrasound appliance;

4 any lithotripsy appliance; and

5 any pest and rodent control appliance.

**7 Any electronic product used for medical, dental or veterinary
applications em­ploying radio-active nuclides, namely -**

1 any gamma camera;

2 any whole body counter;

3 any positron emission tomography scanner;

4 any linear scanner; and

5 any single photon emission computed tomograph (SPECT).

**8 Any high risk electronic product used for medical or dental
applications, namely -**

1 any intra-aortic balloon pump;

2 any electronically controlled ventilator;

3 any electronically controlled anaesthetic machine;

4 any cardiac pacemaker;

5 any intra-cardiac electro- and phono-cardiographic monitor;

6 any electroconvulsive therapy unit;

7 any photocoagulator;

8 any infusion pump;

9 any syringe pump;

10 any infant incubator;

11 any infant transport incubator;

12 any hyperbaric therapy chamber;

13 any hemodialysis device;

14 any peritoneal dialysis machine;

15 any heart-lung bypass (perfusion) device;

16 any shockwave lithotripsy device;

17 any autotransfusion device;

18 any high pressure injection device;

19 any cryosurgical device; and

20 any transcutaneous O2/CO2 monitor.

**9 Any medium risk electronic product used for medical or dental
applications, namely -**

1 any audiometer;

2 any ambulatory electrocardiographic recorder;

3 any electrocardiograph;

4 any electroencephalograph;

5 any electromyograph;

6 any cardiac catheterisation laboratory system;

7 any physiological monitor (ECG, pressure, respiration, temperature);

8 any phonocardiograph;

9 any non-invasive bloodpressure monitor;

10 any cardiac output computer;

11 any plethysmograph;

12 any evoked response device;

13 any pulmonary function analyser;

14 any bloodgas analyser;

15 any infusion controller;

16 any interferential device;

17 any capnograph; and

18 any diagnostic exercise device, including treadmill and cycle
ergometers.

## Spain

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 11 March 2002

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical Equipment?*

No.

*Can Public Health Institutions buy used or refurbished medical
devices?*

Yes.

*Is there a market for used or refurbished medical devices?*

No. Both private and public health Institutions require new medical
devices.

### Industry Sector Analysis, *Prosthesis/Trauma*, 10 October 2001

Representing 31 percent of total imports (USD 500 million), the United
States is Spain's main supplier. U.S. medical equipment is highly
regarded by Spanish doctors, domestic importers, and distributors, which
consider the U.S. the world leader in this field. The growth in U.S.
imports is estimated at 10 percent annually for the next two years. In
peseta terms Spanish purchases from the United States have grown 43
percent from 1998-2000. This import figure is only for new equipment.
Refurbished medical equipment is allowed to be imported in Spain, but
both the public and private medical providers in Spain want only new
equipment.

## Sri Lanka

###### General Market Condition: No Restrictions, but Government Healthcare Sector Cannot Buy

### *Source:* Report from CS Post (via E-Mail), 31 March 2002

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

Medical equipment is imported duty free into Sri Lanka. There is no
special tariff in the case of used or refurbished medical equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Public Health Institutions are prohibited from buying used or
refurbished equipment. The Government health sector is required to
purchase only brand new medical equipment.

*Is there a market for used or refurbished devices?*

According to medical industry sources top private hospitals and medical
service providers are not in favor of purchasing used medical equipment.
Private medical equipment companies are also not keen to import
used/refurbished medical equipment. The key factor is the inability of
foreign suppliers of used equipment to provide after sales services,
parts and manufacturers' warranties. However, they see limited prospects
for used medical equipment, from smaller hospitals and medical clinics.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

Small hospitals, medical and dental clinics may require refurbished
dental equipment, and other medical equipment ranging from ECG machines
to ultra sound scanners. Well-known U.S. brands would have acceptance in
the local market, if refurbished and supplied by the manufacturer. There
is little or no demand for used medical equipment supplied by third
parties. The key factors would be competitive prices compared to brand
new equipment and efficient and comprehensive after sales service.

## Sweden

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 31 March 2000 (Confirmed as still accurate, 26 March 2002) {#source-report-from-cs-post-via-e-mail-31-march-2000-confirmed-as-still-accurate-26-march-2002 .unnumbered}

There are no special restrictions or tariffs that apply to used
equipment that do not apply to new medical equipment. (The CE mark
required on all medical equipment marketed in Sweden). According to
trade association there is no market for used or refurbished medical
equipment. When replacing outdated medical equipment the public health
institutions prefer to purchase new equipment.

## Switzerland

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 13 March 2001 (Confirmed as still accurate, 15 April 2003)

Switzerland is a small, highly developed and affluent market. It
maintains one of the best health care systems in the world. Therefore
importation of used medical equipment is practically non-existent. As a
matter of fact, hospitals and doctors donate their used medical
equipment/furniture to third world countries.

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

The same tariff rates apply to used medical equipment as to new ones.

*Can public health institutions buy used or refurbished Medical
devices?*

Public health institutions can buy used equipment, however, is
practically never done.

*Is there a market for used of refurbished devices?*

No. The market is practically non-existent.

### *Source:* Report from CS Post (via E-Mail), 15 April 2003

A distinction is to be made between a \"fully refurbished device\" and a
used medical device that is in the state of operability and has been
subjected to the necessary maintenance, but which has not been upgraded
or otherwise altered. An altered or upgraded device (\"fully refurbished
device\") has the identical status as a new device and must therefore be
subjected by the refurbisher to a conformity assessment procedure for
CE-marking as a new device before it can be placed on the market in its
refurbished state. Any used device may be placed on the market provided
it is appropriately CE-marked by the original manufacturer.

Switzerland has fully transposed the European Medical Devices Directives
90/385/EEC, 93/42/EEC and 98/79/EC into national law. Due to the Mutual
Recognition Agreement with the EU, Switzerland participates in the
European Market of Medical Devices. The language requirements for the
labeling of devices in Switzerland are German, French and Italian. For
certain devices also English may be acceptable. Further details are
available from the Medical Devices Ordinance (MDO) at the following
website:

www.swissmedic.ch/md.asp

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

There are no special restrictions or tariffs that apply to used medical
equipment. Items 9018 to 9022 of the Swiss Customs Tariff cover medical
devices. Import duty ranges from SF 14.00 to SF 88.00 per 100 kilograms
gross weight. In addition a VAT of 7.6 percent is levied. Further
information on tariffs can be obtained at:

> Federal Customs Administration\
> Oberzolldirektion\
> Monbijoustrasse 40\
> CH-3003 Bern, Switzerland\
> Tel: 41-31-322-65-11\
> Fax: 41-31-322-78-72\
> E-Mail: zentrale.ozd-tarif@ezv.admin.ch

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subjected to
new safety inspections, etc.?*

Parallel import of devices is possible. Anyone importing such a device
must have the corresponding declaration of conformity (according to the
requirements of the EU Directive 93/42/EEC) for the device and the
necessary EC-Certificates. If a device of class I is imported from a
non-EEA country, there is the obligation to notify Swissmedic (MDO, art.
6). This holds also for custom-made devices and system and procedures
packs.

*Can Public Health Institutions buy used or refurbished medical
devices?*

There are no legal provisions in the MDO prohibiting a Public Health
Institution from buying or importing a used or refurbished medical
device---as long as the conformity of this device can be demonstrated
according to the requirements of 93/42/EEC and the importing party
fulfills notification requirements (MDO art. 6) as well as the product
surveillance responsibilities (MDO, sect. 5).

*Is there a market for used or refurbished medical device?*

There are no statistical data on the Swiss market of used and
refurbished devices. However, this market is appears to be characterized
by export activities.

## Syria

###### General Market Condition: Prohibited (except for Expatriate Doctors Returning with Equipment for Their Own Use)

### *Source:* Report from CS Post (via Cable), 3 April 2003 {#source-report-from-cs-post-via-cable-3-april-2003 .unnumbered}

According to Syrian laws and regulations, the import of used or
refurbished medical equipment is not permitted. The government has
recently allowed expatriate doctors returning permanently to Syria to
bring back their used hospital and medical equipment for use in their
own clinics exclusively.

### *Source:* Report from CS Post (via Cable), 17 February 2000 {#source-report-from-cs-post-via-cable-17-february-2000 .unnumbered}

Syrian regulations prohibit the importation of used or refurbished
medical equipment. The import licenses for medical equipment issued by
the Ministry of Economy and Foreign Trade require the importer to
acknowledge that the medical equipment being purchased is 'new equipment
and not refurbished.'

## Taiwan

###### General Market Condition: No Restrictions

### *Source:* ISA Medical Electro-Diagnostic Apparatus, 1 December 1999 (Confirmed as still accurate 28 March 2002)

#### U.S. Market Position

The market for used or refurbished medical devices is virtually
nonexistent in Taiwan. Local hospitals prefer to buy new equipment and
their budgets currently permit them to do so. Apart from the normal
medical device registration, used equipment will likely face difficult
market challenges in Taiwan.

### *Source:* Report from CS Post (via Cable), 27 July 1998 (Confirmed as still accurate 28 March 2002) {#source-report-from-cs-post-via-cable-27-july-1998-confirmed-as-still-accurate-28-march-2002 .unnumbered}

The importation of the following categories of used equipment is
restricted in Taiwan: cars; equipment and parts used in the aerospace
industry; equipment and parts used in ships and vessels; and generators
and compressors with diesel engines. All other imports are treated the
same as new

## Tanzania

###### General Market Condition: No Restrictions, but Public Institutions Cannot Buy

### *Source:* Report from CS Post (via E-Mail), 15 March 2002 {#source-report-from-cs-post-via-e-mail-15-march-2002 .unnumbered}

Tanzania is pursuing a very flexible import administration regime on
used and refurbished equipment in general. According to the East African
Customs and Transfer Tax Management Act of 1952 Revised 1970 as applied
by Act Number 19 of 1977 Section 14 and 15, there is no import
restriction on used equipment in Tanzania.

However, on consignment basis, importation of used equipment into
Tanzania is subject to inspection, verification and certification on its
usability, suitability and appropriateness as governed by the Standards
administered by the Tanzania Bureau of Standards (TBS) and any other
Law. This is mostly applicable to items in the sensitive sectors that
affect health and security.

Several industrial sectors have licensing and inspection boards. For
instance, the National Medical and Pharmaceutical Board, under the
Ministry of Health, handles medical equipment whereas Tanzania Bureau of
Standards (TBS), under the Ministry of Industry and Trade, is charged
with the administration of standards issues including 572 published
standards. TBS is a member of the International Organization for
Standards (ISO) and has been notified to the WTO as the contact point
for issues related to the Agreement on Technical Barriers. Most
Tanzanian standards are voluntary in nature and TBS adopts international
standards whenever they exist. Sanitary and phytosanitary standards are
the responsibility of the Ministry of Agriculture and Food Security
(MAFS), which conducts an inspection and certification program for all
imports of plant and animal products.

Motor vehicles of Japanese origin, continue to be the largest single
group of used/reconditioned imported items into the country. The reforms
that Tanzania has undertaken since 1985-and at a more accelerated pace
in the past few years-have resulted in a trade policy framework that has
been significantly liberalized and that is essentially based on tariffs.
Liberalization of trade increased the volume of used equipment imported
in other industrial sectors as well, especially office equipment
(computers) and domestic appliances. Used items from various industrial
sectors have been imported mostly through the free ports of the Middle
East, South East Asia, Europe and South Africa. The United States of
America continues to have negligible direct share of this trade in
Tanzania despite the fact that some of the imported equipment is of U.S.
origin.

Imports of used or refurbished equipment are receiving similar treatment
as new ones. The whole scope of commercial goods being imported into
Tanzania is subject to the same system of valuing goods for customs
purposes which is fair, uniform, neutral and conforms to commercial
realities.

Tanzania is implementing WTO Agreements including the Agreement on
Customs Valuation (ACV). The procedure for valuation of goods for
taxation purpose that is now in use is known as 'Agreement on Customs
Valuation (ACV) '. ACV prohibits the use of arbitrary or fictitious
Customs values. Pre-Shipment Inspection (PSI) is applied to goods of a
value of above US Dollars Five Thousand (\$ 5,000). Since duties are
mainly levied on an ad valorem basis (based on value), a common problem
is evaluating the equipment's current worth. Often, importers have been
blamed, by the customs department, for under invoicing. In such cases,
depreciation of the equipment had to be re-evaluated by the customs in
collaboration with local dealers of the subjected item before an
appropriate duty could be levied.

The recent reform of Tanzania's customs duties (customs tariff
structure) has resulted in a simplified four-tier structure with tariff
rates of 0 percent, 10 percent, 15 percent and 25 percent in that order.
Pharmaceuticals and medicaments, motor vehicles in CKD form and inputs
for manufacturing pharmaceutical products, raw materials, capital goods
and replacement parts fall under zero tariff.

There is no absolute ban on the import of any type of used equipment to
Tanzania. There is a market for used or refurbished medical equipment in
Tanzania. Used hospital/medical equipment has to attain the approval of
the National Medical and Pharmaceutical Board. Used X-ray machines are
not recommended. Used dental and medical laboratory equipment are in the
greatest demand. Neither public health institutions ror the Government
of Tanzania can buy used or refurbished medical devices. Nuclear
substance processing equipment requires an approval from the Commission
on Atomic Power within the Tanzania Commission of Science and
Technology.

Importation of used / refurbished equipment is growing fast in Tanzania.
Motor vehicles of all ranges, tractors, television sets, computers,
VCRs, refrigerators, cookers, photocopiers, sewing machines, hair
dressing equipment, retread and used tires, used construction equipment,
generators and engine parts, are some of the most notable used imported
items. Japan has been leading in the export of reconditioned cars, which
account for more than 75 perent of the value of the imported equipment.
Germany, Sweden, United Kingdom, Italy, the Middle East, Denmark,
Australia and South Africa are the main source of used domestic,
industrial, construction and office equipment. These four industrial
sectors are prospects for U.S. suppliers in Tanzania.

## Thailand

###### General Market Condition: Prohibited

### *Source:* Report from CS Post (via Cable), 21 March 2002

The Government of Thailand prohibits the importation of used or
refurbished medical equipment into the country, but does not prohibit
sales of those devices.

The potential market for refurbished devices is strong, especially for
non-invasive, non-life-threatening devices. They include pulse
oximeters, bedside monitoring devices, and blood pressure-monitoring
devices.

### *Source:* Industry Sector Analysis, *Healthcare Products*, 8 March 2002

The Medical Devices Control Division, Food and Drug Administration,
Ministry of Public Health, controls importation of medical devices into
Thailand. Prior approval of importation and device registration through
this office is required. Any devices that are not allowed to be marketed
or sold in the manufacturing country will not receive permission to be
registered in, or imported into Thailand. The Thai Government does not
allow importation of used or refurbished medical equipment.

### *Source:* Report from CS Post (via E-Mail), 1 April 2001 (Confirmed as still accurate, 21 March 2002)

The Government of Thailand prohibits the importation of used or
refurbished medical equipment into the country, but does not prohibit
sales of those devices. Public health institutions have a policy that
prohibits the purchase of used or refurbished devices because of
concerns about quality and reliability.

On the other hand, there is a market for refurbished devices among
private health institutions, specifically non-invasive,
non-life-threatening devices. The devices in this group include pulse
oximeters, blood pressure monitoring devices, and other bedside
monitoring devices. These devices are traded locally among the private
health institutions. There is also a good potential for sales of device
calibration services to both public and private hospitals in Thailand.

## Trinidad & Tobago

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 28 March 2002 {#source-report-from-cs-post-via-cable-28-march-2002 .unnumbered}

There are no special restrictions or tarriffs that apply to used medical
equipment that do not apply to new medical equiment. Duties are charged
based on the cost of the product. Documentary evidence of cost is
required. Public health institutions seldom buy used or refurbished
medical devices. The market for used or refurbished medical devices is
very small.

## Tunisia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 30 October 1998 (Confirmed as still valid, 4 March 2002) {#source-report-from-cs-post-via-cable-30-october-1998-confirmed-as-still-valid-4-march-2002 .unnumbered}

According to the Tunisian Ministry of Commerce, there are no statutory
prohibitions on the import of used/refurbished equipment. Imports of
used equipment are subject to strict control by the Ministry of
Industry, whose inspectors verify the proper functioning of all used
equipment imports.

There are no specific restrictions on individual categories of
used/refurbished equipment, but each import is reviewed thoroughly and
is admitted entry on a case-by-case basis.

While regulations are minimal, importation of used equipment into
Tunisia is difficult as there is a strong preference for guarantees and
after-sale service which comes with new equipment. Local banks that
finance industrial products normally require that purchased equipment be
new. Used equipment is sometimes imported as part of a foreign
investor's contribution-in-kind to the capital of a project. The
purchase of used equipment for government-funded projects is permitted
only in exceptional circumstances.

The United States is Tunisia's fourth largest foreign supplier and U.S.
technology is held in high regard in Tunisia for its state-of-the-art
technology. Given the difficulty of assessing the true ease of entry for
used equipment and the general Tunisian preference for new items,
however, the Tunisian market is not particularly well suited for
used/refurbished U.S. equipment exports.

## Turkey

###### General Market Condition: Restricted

### *Source:* Turkey Country Commercial Guide FY 2002

#### Leading Sectors For US Exports And Investments Name of Sector: Medical Equipment ITA Industry Code: MED

Turkey's demand for medical products and related equipment is expected
to continue to grow in the coming years. The current total market size
for the overall medical equipment sector is approximately US\$ 750
million, with the U.S. share being a healthy fifteen percent. The
estimated annual growth rate of imports from the United States is 20
percent.

In recent years, the Government of Turkey has allocated more funding to
healthcare, substantially improving most of Turkey's healthcare
standards. However, healthcare services are still inadequate to cope
with a rapidly expanding population (currently about 65 million and
growing by nearly two percent annually). Health expenditures represent
approximately 5 percent of GNP.

The Turkish Ministry of Health (MOH) is the largest provider of
healthcare in Turkey. Health care facilities operated by MOH account for
approximately 84,000 beds. Other government agencies including the
Ministry of National Defense, Social Security Agency (SSK), various
public sector medical faculties and municipalities account for an
additional 70,000 beds. The private sector, including foreign
organizations and various associations, operate a total of 15,000 beds.

The private sector is actively expanding its role in the health sector.
New capital-intensive medical technologies, such as magnetic resonance
imaging (MRI), computed tomography (CT), and megavolt radiation therapy
will continue to be purchased by Turkish hospitals. Major suppliers are
the United States, Europe, and Japan. The Turkish business community has
a high opinion of U.S. medical equipment and suppliers.

Demand for used, refurbished equipment (traditionally low), has
increased over the last few years and is becoming an alternative source
for emerging distributors and end-users because of lower prices and
shorter delivery time. Current Turkish import regulations permit the
importation of used equipment, no more than five years old. Equipment
between five and ten years old is technically subject to a 50 percent
import duty. The importation of devices over ten years old is
prohibited.

The World Bank contributes to the financing of the government's
healthcare improvement projects and has lent \$76 million and \$140
million respectively for the First and Second Health Projects between
1991 and 2001. Total investment required for these two projects was
\$346 million, and the Turkish Government supplied the remaining
portion.

Most major government tenders outside the scope of the World Bank Health
Project still require supplier credit. The GOT also encourages use of
the 'Build-Operate-Transfer' (BOT) model as a means of procuring
equipment for which funds are scarce. The BOT model calls for the vendor
to install and operate the equipment, receive the revenues from the use
of equipment, and finally transfer the equipment at the end of a
specified period that covers expenses and profit.

Effective June 1, 1996, all medical equipment imports are subject to the
Turkish Standards Institute (TSE) approval. USFDA approval is regarded
as a seal of quality. Medical devices for sale (without restrictions) in
the United States may normally be imported for sale in Turkey.

## Turkmenistan

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 29 March 2000 {#source-report-from-cs-post-via-cable-29-march-2000 .unnumbered}

So far, the government of Turkmenistan (GOTX) has introduced no rules
regulating import of used and/or refurbished medical equipment in
Turkmenistan. Import of such medical equipment is treated the same way
as import of new equipment.

U.S. companies that plan importing used and/or refurbished medical
equipment to Turkmenistan should be alert when a contract is negotiated.
It should be clarified in the contract that import of used and/or
refurbished medical equipment is agreed to by all parties participating
in a transaction. Otherwise, a dispute with regard to the quality of
imported equipment may arise. There have been such claims in the past.

So far, there have been no excise taxes or customs tariffs charged for
imported used and/or refurbished medical equipment. Moreover, the
customs and the state commodity and raw materials exchange do not charge
service fees from those trade contracts where medical equipment is a
part of a transaction. The main obstacle for U.S. companies planning to
sell medical equipment in Turkmenistan is the non-convertibility of the
Turkmen currency; hard currency is rationed, and importers must justify
to the government their need for hard currency to pay for the goods they
import.

The Turkmen market with a population of five million is relatively small
and underdeveloped in terms of medical equipment supplies as well as
medical personnel training and management. Needs are substantial, but
means are limited. There is no medical equipment production in
Turkmenistan and a potential market for used medical equipment does and
will continue to exist here. So far, the GOTX has built a new
pharmaceutical plant with the involvement of Indian Government credit
line and maintains operation of an out-of-date pharmaceutical production
facility in Ashgabat. Nonetheless, the Turkmen market relies heavily on
imported medical items and pharmaceuticals. There are no Turkmen private
clinics and hospitals in the country except for a Turkish private
hospital, which has been operating in Ashgabat since 1998. The GOTX will
continue to be the main partner in any investment project in the health
care sector for the next decade. The only privatization that has taken
place has involved the creation of local private drugstores. The
Ministry of Health Care and Medical Industry, which handles the state
investment fund for health care sector development, is responsible for
financing health care projects. According to the Ministry of Health Care
and Medical Industry, the market demand for medical equipment is
evaluated at US\$ 50 million. However, this figure could be much higher
providing the GOTX has sufficient hard currency reserves in the
investment fund.

In order to import foreign medical equipment into Turkmenistan including
used and refurbished, one must be licensed for importation by the state
center for registration of imported medical equipment and approved by
Turkmenmedtekhnika, a state company handling medical equipment use and
importation. The state inspectorate 'Turkmenstandartlary' provides
certification of the imported medical equipment. Other government
approvals also apply.

## Uganda

###### General Market Condition: No Restrictions but Public Healthcare Institutions Do Not Buy Used Equipment on Open Tenders

### *Source:* Report from CS Post Kampala (via E-Mail), 1 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment but do not apply to new medical equipment?*

No.

*If a manufacturer or its agent has registered a medical device in the
country, can a third part legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections, etc.*

The only medical products registered in Uganda are pharmaceuticals. Any
other medical products aren\'t registered. In order to import a medical
device it is necessary to import through a registered pharmaceutical
company in Uganda. A fee of the F.O.B value is paid to the National Drug
Authority. The National Advisory Committee on Medical Equipment may
advise the importer on the suitability/compatibility of the device in
question but has no authority to bar an importer from importing whatever
device he wishes to import.

*Can public health institutions buy used or refurbished medical
devices?*

Yes, but not on open tender, which follows the normal public procurement
guidelines, which stipulate that all equipment purchased has to be new.

*Is there a market for used or refurbished medical devices?*

Yes, when a government institution is not involved. Since government
purchases are normally made using loans/grants from donor countries,
conditions are typically attached to the use of that money requiring
that equipment be pruchased from the donor country.

*If there is a market, what types of used or refurbished equipment
medical equipment are in greatest demand?*

Electrocardiagram Machines, X-Ray Equipment and Ultrasound equipment

Note: The source for the above information was Dr. Jjemba, Head of
Procurement, National Medical Stores.

## Ukraine

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 10 April 2003

#### Regulatory Agency 

The act of registering or re-registering medical use products in Ukraine
is performed by the State Department of Quality Control, Safety and
Manufacture of Medicinal and Medical Use Products.

#### Registration Procedures 

Procedures for registering medical equipment and medical use products
were approved by the Ministry of Health of Ukraine on September 26,
2000. The procedure was filed by the Ministry of Justice of Ukraine on
January 17, 2001, and is now law.

Registration is a requirement for the importation of medical products
into Ukraine.

There is no special procedure for registration of used/refurbished
medical equipment. There are no special restrictions or tariffs that
apply to used medical equipment.

Applications for registration must be submitted (on a standard form) to
the State Department on Control of Quality, Safety and Manufacture of
Medicinal and Medical Use Products (see below).

In addition, the following must also be provided with the application:

-   Catalogues of the product,

-   Manuals,

-   Technical specifications,

-   Certificates (manufacturer\'s certificate, certificate of origin),

-   Foreign certificates (if available),

-   A certificate of conformance issued by a ukrainian certifying agency
    (if available),

-   Information on manufacturing standards (if available),

-   Trade mark samples, and

-   Manufacturer\'s registration documents.

Registration is performed by the State Department on Control of Quality,
Safety and Manufacture of Medicinal and Medical Use Products, and is
based on evaluation of the product by expert testing agencies. Once
registered, a product is included in the State register of medical
equipment and medical use products.

Registration is valid for five years. The procedure for renewal of
registration is the same as described above.

If a manufacturer or its agent has registered a medical device in the
country, a third party can legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections and registration.

Public health institutions can buy used/refurbished medical devices if
these devices are registered in Ukraine.

Receptivity for used dental equipment is average; as the price
difference between local and imported used equipment has narrowed, the
motivation to purchase used equipment has also decreased. However, a
potential market for used dental equipment exists, the preferred
approach being the creation of a refurbishing joint venture with local
partner.

#### Registration Form Requirements

*A. General information*

-   Name of the medical use product -synonyms, trade mark (in original
    language, in English, and in Ukrainian).

-   Applicant (country where the applicant is registered, address,
    phone, fax, e-mail, national registration number and code).

-   Manufacturer (country where the manufacturer is registered, address,
    phone, fax, e-mail, national registration number).

-   Document confirming the authority of an applicant to represent a
    manufacturer (if an applicant is not a manufacturer - a contract, or
    power of attorney).

-   Ukrainian customs code for the medical use product.

*B. A certificate of conformance issued by a Ukrainian certifying
agency.*

I certify that the applying product complies with quality and safety
requirements, as stated in the supporting documentation, and with
requirements of Ukrainian legislation as to quality and safety for human
health and the environment.\
\
Date Signature of applicant

The documents that confirm the compliance of goods with Ukrainian
certification requirements are:

-   A certificate of conformance issued by a Ukrainian certifying
    agency, upon certification of goods; or

-   A certificate of acceptance of a foreign certificate issued by a
    Ukrainian certifying agency, upon acceptance of a foreign
    certificate.

Note: Certificates issued by foreign authorities are recognized in
Ukraine only to the extent provided in international treaties to which
Ukraine is a party. No intergovernmental agreements on goods
certification exist between Ukraine and the U.S. and a certificate of
acceptance of a foreign certificate may not be issued without the actual
testing of the product.)

#### Contacts

Contact at the State Department on Control of Quality, Safety and
Manufacture of Medicinal and Medical Use Products, Division for
Registration and Certification of Medical Equipment and Medical Use
Products:

Yaroslav Penishkevich, Head of the Medical Equipment Division\
120 Pobedy Ave., of. 9\
Kiev 03142\
Ukraine\
Tel/fax: (380-44) 444-7253, 444-2571, 444-1048\
E-Mail: <yary@cmt.kiev.ua>

For additional information on the medical industry sector in Ukraine,
please contact your nearest USDOC Export Assistance Center, with a copy
to:

Frank Carrico, CS Kiev Senior Commercial Officer\
Olena Stephanska, CS Kiev Commercial Specialist,\
The Commercial Service, U.S. Embassy Kiev,\
4 Hlybochytska St., Kiev 04050, Ukraine\
Tel: (380-44) 490-4018;\
Fax: (380-44) 490-4046\
E-Mail: kiev.office.box@mail.doc.gov\
E-Mail: <Olena.Stephanska@mail.doc.gov>

### *Source:* Report from CS Post (via E-Mail), 30 March 2001

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no special restrictions or tariffs that apply to used medical
equipment in Ukraine.

*Can public health institutions buy used or refurbished Medical
devices?*

Public health institutions can buy used and refurbished medical
equipment.

*Is there a market for used of refurbished devices?*

The market for used medical equipment is small in Ukraine---importers
prefer to buy new equipment, although new equipment is more expensive.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

The demand for used equipment is to be identified on case-by-case basis.

## United Arab Emirates

###### No Restrictions, but Public Health Institutions Cannot Buy

### *Source:* Report from CS Post (via E-Mail), 16 April 2003

*Are there special restrictions or tariffs that apply to used medical
equipment?*

There are no special restrictions or tariffs that apply to used
equipment that do not apply to new equipment. The same customs charges
of 5 percent is levied on both new and used equipment.

*If a manufacturer or its agent has registered a medical device in the
country, can a third party legally import the same device in
used/refurbished condition without the used device being subject to new
safety inspections, etc.?*

A third party can import used medical equipment even if its agent has
registered the device in the United Arab Emirates (UAE). Yet this
imposes after sale maintenance issues especially for high-tech
equipment, where only registered agents have after sale maintenance
capabilities and registered agents might not accept to provide
maintenance. At the same time if import documents specify a brand that
has an agent in the UAE, only the agent can clear on these items with
Customs Department. With that said, the usual practice has been not to
specify the brand/manufacturer, rather the name of supplier. Neither new
nor used/refurbished medical equipment are subject to safety inspection
by the local authorities.

*Can public health institutions buy used or refurbished medical devise?*

Government regulations does not permit Public health institutions to buy
used or refurbished medical equipment.

*Is there a market for used or refurbished medical devices?*

The government in the UAE is the main healthcare provider. Government
healthcare services account for 80 percent of the market. Only 20
percent of the market for healthcare services is supplied by the private
clinics and hospitals. The majority of the bigger private clinics and
hospitals prefer and can afford new equipment. Therefore, the market for
refurbished medical equipment/devices is the UAE is rather limited.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

As stated above, the market is limited to smaller private clinics and
hospitals. These usually buy refurbished imaging, diagnostic, radiology
and ultrasound equipment. Yet, although the market for refurbished
medical equipment is limited in the UAE, there seem to be a market of
the same for re-export to neighboring countries.

## United Kingdom

###### General Market Condition: No Restrictions, but CE Mark is Required

*See also entry for the European Union.*

### *Source:* Report from CS Post (via E-Mail), 22 March 2002

The United Kingdom has a growing requirement and interest for used
medical equipment, across all sectors. The majority of such purchases
are made by hospitals that are part of the United Kingdom's
government-funded National Health Service (NHS). Such pre-owned
equipment is subject to the same import duties and regulations as new
devices.

The U.K. medical equipment market is driven by the NHS---the United
Kingdom's universal, publicly funded healthcare system---which accounts
for about 85 percent of total U.K. healthcare provision. As such, the
NHS accounts for the majority of medical equipment purchases in the
\$3-billion U.K. market.

In the past, NHS purchases of used medical equipment have focused on
radiology equipment such as X-ray machines and scanners. Currently, NHS
demand covers all sectors: large surgical equipment, radiology equipment
and other medical diagnostic equipment. Given the NHS' recent moves to
improve the standard of care for cancer patients, the market for all
pre-owned diagnostic medical equipment should increase.

The majority of used medical equipment procured by the NHS is purchased
by individual hospital trusts, which are regional groupings of the 1,578
NHS hospitals. Contact information for these trusts can be found at
[www.doh.gov.uk]{.underline}.

The NHS also has a central purchasing organization---the NHS purchasing
and supplies
agency---([www.pasa.doh.gov.uk](http://www.pasa.doh.gov.uk/)) that
influences more than half of the NHS' total spend on supplies. Although
NHS hospitals are not required to purchase from this agency, over 98
percent of NHS trusts place all, most, or some of their business with
the organization. Contacts at this agency report that in the past they
have done little procurement of used medical equipment but have recently
been approached by a U.S. company who sells pre-owned medical equipment
and was very interested in exploring similar opportunities. Senior
buyers at PASA told us that they were there certainly was an important
niche for pre-owned medical equipment in the UK market. The NHS
purchasing and supplies agency can be reached on 44-1244-586-859.

In addition, over the next three years, the NHS will be purchasing
\$150-million worth of new cancer equipment---including diagnostic
equipment, linear accelerators, and breast screening equipment---for
over 200 hospitals. The purchases will be funded by the U.K. National
Lottery's New Opportunities Fund (NOF), contact information for which
can be found on the website [www.noh.org.uk]{.underline}.

Private sector procurement of medical equipment is financed by the
individual organization or hospital group. There are currently 229
private hospitals in the United Kingdom, and these organizations
purchase very limited amounts of used equipment, if any at all.
Information on the U.K. private healthcare sector can be found on the
website [www.iha.org.uk]{.underline}.

Any used or refurbished medical equipment sold in the U.K. market faces
the same restrictions and regulations as new equipment. As with a new
medical device, a used or refurbished medical device must obtain a CE
mark that enables the product to be marketed anywhere within the EU. To
obtain a CE mark, full compliance with the appropriate EU directive must
be achieved. The three main EU medical devices directives are the EU
Medical Devices Directive, the Active Implantable Medical Devices
Directive, and the EU In-Vitro Diagnostic Medical Devices Directive (to
be fully implemented in December 2005).

If a product has obtained a CE mark and is then refurbished, no
re-registering is required if the product is refurbished with original
equivalent parts (i.e. parts must meet manufacturer specifications). If
significant alterations occur, previous regulatory approval could be
invalidated.

Within the United Kingdom, the U.K. Medical Devices Agency (MDA)
enforces regulations and deals with inquiries concerning compliance to
the EU directives. Information about the MDA and full descriptions of
the EU directives can be obtained on the Webster
[www.mca.gov.uk]{.underline}

Used or refurbished medical equipment is subject to the same import
duties as new devices. The majority of medical equipment is classified
into one of two categories in the Harmonized Tariff Schedule (HTS): HTS
9018 (medical, surgical, and dental instruments and apparatus) and HTS
9402 (medical, surgical, and dental furniture). New or used medical
equipment classified under HTS 9018 and 9402 can be imported into the
United Kingdom duty-free. A 17.5 percent value-added tax (VAT) is levied
on the CIF value of the products (the value of the product, plus
carriage, insurance, and freight).

## Uruguay

###### General Market Condition: Restricted

### *Source:* Report from CS Post (via E-Mail), 28 March 2001 (confirmed as still accurate 21 March 2002)

Unfortunately there would appear to be no niche for used medical
equipment in the Uruguayan market. Tariffs on used items are applied on
the value if new! Moreover, as a member of Mercosur, Uruguay applies a
common external tariff to products coming from outside Mercosur. The
common external tariff in some cases is as high as 16.5 percent, whereas
the tariff on medical equipment coming from the other Mercosur countries
is zero percent.

Although the same regulations apply to used equipment as to new
equipment, the Ministry of Public Health tends to make the procedures
extremely troublesome (even in the case of donations!), so local
importers do not look for used equipment. The Ministry of Public Health
will accept used equipment as donations only and they make it difficult
for themselves also!

Local costs for repairing/refurbishing are low with high skills. So when
upgrading, high-end institutions/users tend to sell their equipment to
those with lower technologies and they can then have it as new at low
costs.

## Uzbekistan

###### General Market Condition: Restricted

### *Source:* International Market Insight, Import Regulations for Medical Equipment in Uzbekistan, 2 April 2002 (Updated: 16 May 2003)

#### Summary

The act of registering or re-registering of products for medical use in
Uzbekistan is performed by the Head Department of the Drug and Medical
Equipment Quality Control (HDDMEQC), Public Health Ministry of the
Republic of Uzbekistan.

The procedures for registering medical equipment and related products
were issued by the Cabinet of Ministers of Uzbekistan on May 25, 1995
and then were approved by the Ministry of Health.

Registration is a requirement for the importation of new medical
products into Uzbekistan. Once registered, a product is included in the
State register of medical equipment and medical related products.

Registration is valid for five years.

#### Regulations for Used Medical Equipment

Medical equipment that has been in use does not need to be officially
registered in the Republic of Uzbekistan. However, all medical equipment
imported to the territory of Uzbekistan should pass the governmental
certification. The companies are advised to get the copy of the
government quality technical standards, which are applicable to the
imported type of equipment. The utilization of used and refurbished
medical equipment in hospitals and testing institutions is possible only
after passing the strict quality, suitability and security conditions in
a technical evaluation with the technological experts from a special
commission, created under HDDMEQC RU. Medical equipment, which is
supplied through humanitarian aid, can be distributed to the final place
of destination, only after certification testing.

***Most Promising Markets for Used Medical Equipment***

The best market potential for used and refurbished U.S. manufactured
medical equipment is expected to be in the following areas: Dental
equipment, diagnostic equipment, laboratory scientific instruments and
supplies, and rehabilitation equipment for the private hospitals.

#### Methods of Procurement

The Ministry of Health officials (MOH) and local companies underlined
that they prefer working directly with manufacturers, and not with
intermediaries. Medical equipment and supplies are primarily financed
from the State budget and loans from the World Bank or other banks and
agencies.

To sell medical equipment to MOH entities, an American company must be
sure: (1) the MOH has some funding either from the state budget or a
loan, and (2) the main MOH suppliers of medical equipment (such as
Uzmedexport or Tibmahsulot) have the necessary information about the
American company's products. U.S. companies interested in doing business
in Uzbekistan should provide the two main Uzbekistan suppliers with
catalogues of their products and information on the companies, their
goods and services.

To sell medical equipment to other, non-MOH financed state medical
entities, an American company should have a distributor or a dealer that
will go to these clinics and hospitals to evaluate the needs, display
the equipment, and persuade medical personnel to buy the equipment. If
the company and medical personnel come to an agreement, the chief
medical officer of the hospital or clinic will go to the relevant
regional or municipal authorities to request funding. Such payments are
generally done through the National Bank of Uzbekistan.

The NGOs are another tool for exporters to find end-users of medical
equipment by means of the organizations of different types of seminars,
training, launch meetings for local doctors within the country.

#### Non-state Purchasers

The medical technologies are a State-controlled sector. However, the
private hospitals and doctors themselves could be potential customers
for used and refurbished medical equipment. It is also necessary to
point out that the older generation doctors who were trained during the
Soviet period have the inclination to buy German or Russian medical
devices. The younger generations of doctors have the opposite
inclination to purchase modern digital equipment, manufactured in U.S.
or Japan.

#### Resources of Uzbek Health Services

Uzbek Health Statistics

  -------------------------------------------- --------------------------
  Item                                         Number

  Physicians                                   73,389

  Medium level medical personnel               249,337

  Regional hospitals                           22

  Municipal hospitals                          120

  Central district and district hospitals in   198
  rural area                                   

  Community hospitals                          198

  Maternity homes                              53

  Other specialized hospitals and institutions 255

  Institutions with units of resuscitation and 417
  intensive therapy                            

  Number of their beds                         3,016

  Emergency medical centers                    155

  Number of their beds                         131,478

  Medical ambulatory-polyclinic institutions   3,679

  Blood transfusion stations                   17

  First-aid stations (departments)             213

  Sanitary-epidemiological stations            225
  -------------------------------------------- --------------------------

#### Main Contact Information

The package of standard forms can be obtained at the Receptionist Desk
of Committee on new medical technology of the Head Department of Drug
and Medical Equipment Quality Control at the address below.

More information can be obtained from:

Mr. Abdunamon Sidikov, Head of External Economic Activities Department\
Ministry of Health of Uzbekistan\
30 Abdullaeva Street,\
Tashkent 700011, Uzbekistan\
Tel: (998) 712 68 26 32, 68 08 11, 1690021\
Fax: (998) 712 1690021

Mr. Akhmat Yunuskhojaev, Director of Head Department of Drug and
Medical\
Equipment Quality Control\
Ministry of Health of Uzbekistan\
Usmankhodjaev Street, 16 K.Umarov passage\
Tashkent 700002, Uzbekistan\
Tel: (998) 712 49 47 93, 144 48 23, 144-48-18\
Fax: (998) 71 144 48 25

Mrs. Gulnora Tillaeva, Chairmen, Doctor of Technical Science, Professor\
Committee on new medical technology\
Head Department of Drug and Medical Equipment Quality Control

Ministry of Health of Uzbekistan\
Usmankhodjaev street, 16 K.Umarov passage\
Tashkent 700002, Uzbekistan\
Tel: (998) 712 49 47 27, 144 48 23Fax: (998) 71 144 48 25\
E-mail: uzpharm@online.ru

Mr. Rasul Dushamov, Head of the Department for the Technical
Development\
Ministry of Health of Uzbekistan\
12 Navoi street\
Tashkent 700011, Uzbekistan\
Tel: (998) 712 41 18 12, 144 10 33\
Fax: (998) 712 41 18 12\
E-Mail: serka@@bcc.com.uz\
Website: www.moh.uz

Mrs. Dina Mukhamadieva, Chairman of the Board\
Counterpart Hamroh, NGO\
11A Donskaya Street\
Tashkent 700077, Uzbekistan\
Tel: (998) 71 169-16-13/14/15\
Fax: (998) 71 169-16-41\
E-Mail: dina@cpart.uz\
Website: www.cango.net

Ms. Tatyana Isaeva, Financial Assistant / Health Care Technologies\
U.S. Commercial Service,\
U.S. Embassy, Tashkent, Uzbekistan\
Tel.: (998) 71 120 67 05\
Fax: (998) 71 120 66 92\
E-Mail: Tatyana.Isaeva@mail.doc.gov\
Website: www.export.gov

**International Mailing Address:\
**41 Buyuk Turon Street, 3rd Floor,\
Tashkent 700000 Uzbekistan

**U.S. Mailing Address:\
**Commercial Service\
Department of State\
7110 Tashkent Place\
Washington, DC 20521-7110

## Venezuela

###### General Market Condition: No Restrictions, but Government Agencies do not Buy

### *Source:* Report from CS Post (via E-Mail), 22 May 2001

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no restrictions or special tariffs for used medical equipment.
The same import duties apply for new and for used equipment.

*Can public health institutions buy used or refurbished medical
devices?*

There are no prohibitions but as a rule the Venezuelan Government
agencies will not buy used or refurbished equipment of any type.

### *Source:* ISA Medical, 1 September 2000

Overall hospitals in Venezuela are not managed efficiently according to
industry analysts. Therefore it has been difficult to build up a reserve
fund for future technology upgrades and acquisitions. The same doctors
work in both the public and the private sectors. However, in the public
sector the government does not provide adequate tools and equipment, nor
the proper infrastructure. This has been the situation over the past
twenty years. In Caracas over the past ten years private hospitals were
unable to make direct investments as they were greatly affected by the
recession. Nevertheless, they managed to form strategic alliances with
the medical distributors, which resulted in many private hospitals
having the latest technology. Unfortunately this kind of initiative has
not taken place in the rest of Venezuela.

Demand of medical equipment and supplies will be determined mainly by
importers' purchasing power, product price and the rate of growth in the
market of used equipment. Local statistics indicate that imports of
refurbished equipment have grown approximately 60 percent over the past
two years. This is the result of the continuous currency devaluation,
the limited access to import new equipment, increased health costs and
patient's diminishing purchasing power. The demand for U.S. refurbished
equipment is becoming an alternative source for distributors and end
users, as long as technical support and service are available.

There is a need in the public health sector for high technology
equipment, such as tomographers, ophthalmologic and optical instruments,
cobalt pumps (nuclear medicine), magnetic resonance chambers, X-ray
apparatus, laboratory and hematology testing equipment, infusion and
transfusion equipment, cancer diagnostic and therapy equipment,
hemodialysis equipment, electrocardiographs, electroencephalographs,
linear accelerators, equipment for heart disease, apparatus for
intensive care units and dental equipment.

## Vietnam

###### General Market Condition: Restricted

### *Source:* Industry Sector Analysis, Medical Diagnostic Equipment, 31 January 2002

The Government has recognized that neither the State budget nor even the
largesse of official development assistance (ODA) donors can cope with
Vietnam's needs for investment in health care facilities, and over the
past few years has promulgated measures to encourage private investment
in this sector, which was previously reserved for the State. Although
private hospitals only serve a limited market of wealthier Vietnamese
and some foreign nationals, the number of private hospitals grew from 6
in 1999 to 10 in 2000, each with around US\$2 miilion in invested
capital. Private hospitals are more open to purchasing new equipment and
employing advanced techniques that will allow them to differentiate
themselves in the market.

Supplementing hospitals, the system also has 19,836 private health care
clinics (many run as 'sidelines' by staff doctors from State-owned
hospitals), 7,015 traditional medicine centers, 3,432 specialized
clinics, and 550 family-run clinics. These establishments are
predominately small-scale and are not likely to procure much high-end
equipment. However, they may represent a market for used equipment with
service and warranty.

Regarding used equipment, Decision 2019/1997/QD-BKHCNMT dated December
1, 1997, stipulates that the Ministry of Science, Technology, and
Environment (MOSTE) must inspect imported used medical equipment.
Imported used medical equipment must retain at least 80 percent of its
life expectancy and must not consume more than 10 percent of fuels or
electricity used by newer versions of the equipment.

### *Source:* ISA Medical, 1 January 2001

#### Import Climate

Importation of medical equipment into Vietnam must go through a trading
company that has an import license. In the past, only state-own
enterprises had licenses to import medical equipment to Vietnam, and
these trading companies charged the real equipment buyers or
distributors a few percent commission rate on the total value of the
imported goods. Now, any business entity, including foreign invested
enterprises that have a legally registered business license, can be
engaged in direct import and export activities.

Decree 11/1999/ND-CP issued on 3 March 1999 stipulates the ban of
medical equipment. Only medical equipment intended for sex enhancement
and aphrodisiac purposes have been clearly identified as banned medical
equipment. Decision 088/2000/QD/BTM issued 18/2/2000 provides further
detailed instructions and a list of banned medical equipment.

According to the Government's Decree 89/CP promulgated on 12 December
1995, each year the Ministry of Health, in consultation with the
Ministry of Trade, issues a list of equipment in which importation must
be registered and approved by the Ministry of Health. Decree 89/CP has
been altered many times and importation of medical equipment is now
regulated by Decision 242/1999/QD/TTg issued on 30 December 1999. Decree
89/CP is now replaced by Circular 05/2000/TT-BTM issued 21 February
2000.

The current list for equipment needing to be registered and approved is
detailed below:

-   CT Scanner and gamma scanner;

-   Cobalt and accelerator equipment;

-   Simulator equipment;

-   Magnetic resonance equipment;

-   Blood filter/sterilizing equipment;

-   Ultra-sound color Doppler equipment;

-   X-ray equipment;

-   Emergency/Recovery equipment;

-   Laboratory equipment;

-   Specialty equipment, i.e. obstetrician, pediatric, and optical
    equipment;

-   Sterilizing equipment

Based on Decision 2019/1997/QD-BKHCNMT issued 1 December 1997, the
Ministry of Science, Technology, and Environment must inspect imported
used medical equipment. The Decision stipulates that imported used
medical equipment must retain equal to or more than 80 percent of its
life expectancy and must not consume more than 10 percent of fuels or
electricity than newer versions of the equipment.

Import tax for medical equipment generally ranges from 0 percent to 5
percent, and the equipment is subjected to a value added tax. Effective
as of 1 January 1999, a new value added tax was imposed on goods and
services consumed in Vietnam. The standard VAT rate for medical
equipment is 5 percent and a spare part is 10 percent. Unless otherwise
approved by the Ministry of Finance, taxes are based upon the calendar
year, regardless of a company's fiscal year. Medical equipment imported
from countries that have bilateral trade agreements with Vietnam receive
a preferential tax rate. Import taxes imposed on medical equipment are
classified in Decision 172/TT-BTC issued on 22 December 1998.

In general, all importation procedures for medical equipment take about
two to three weeks and there are no major difficulties during this
process.

#### Labeling Requirement

On August 30 1999, the Prime Minister promulgated Decision No. regarding
the regulation for labeling of domestically circulated goods and
imported/exported goods. According to this law, label affixation is
required for medical equipment. The importer must provide information on
the label that mentions the

-   Name of the equipment;

-   Name and address of traders responsible for the equipment, i.e., the
    importer in this case;

-   Instructions on using, operating and preserving the equipment; and

-   Origin of the equipment.

### ISA Medical, 1 May 2000

Used equipment, that has been refurbished, has significant market
potential in Vietnam, especially in the private Vietnamese clinic
sector.

## Yemen

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via Cable), 27 March 2001

*Are there special restrictions or tariffs that apply to used equipment
that do not apply to new medical equipment?*

There are no restrictions on the importation of used equipment, except
that it be in good condition. Tariff rates are lower for used equipment
than for new equipment, and this applies to used medical equipment. The
tariff on new medical equipment is five percent. The custom duties are
exempted if the hospital is an investment project, but the used
equipment must not be more than eight years old.

*Can public health institutions buy used or refurbished Medical
devices?*

Yes, public health institutions buy used or refurbished medical devices
when priced competitively with new equipment. Yemen's Ministry of Health
buys medical equipment through the tendering system.

*Is there a market for used of refurbished devices?*

Yes, the market for used medical equipment is good, especially in
private hospitals.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

The greatest demand for refurbished medical equipment is from small
hospitals, clinics and health centers.

Yemen's ministry of Public Health is unable to cope with increasing
demand for modern health services, so it has encouraged the private
sector to establish hospitals and clinics. Statistics indicate that
Yemen has over 105 government hospitals, 200 private hospitals, over 750
health care centers and clinics, and 2,900 pharmacies, representing a
significant market for medical instruments, supplies, and
pharmaceuticals. Yemeni expatriates and businessmen are planning to
invest in larger hospitals. More than 60 private companies are importing
and trading in medical instruments, supplies, and pharmaceuticals.

### Report from CS Post (via Cable), 4 April 2000 {#report-from-cs-post-via-cable-4-april-2000 .unnumbered}

There are no restrictions on the importation of used equipment, except
that it be in good condition. Tariff rates are lower for used equipment
than for new equipment, and this applies to used medical equipment. The
tariff on new medical equipment is five percent.

Public health institutions buy used or refurbished medical devices when
priced competitively with new equipment. Yemen's Ministry of Health buys
medical equipment through the tendering system.

The market for used medical equipment is good, especially in private
hospitals.

Yemen has over 100 government hospitals, 550 small private hospitals and
clinics and over 2,700 pharmacies, representing a significant market for
medical instruments, supplies, and pharmaceuticals. More than 50 private
companies are importing and trading in medical devices. With a
population of 17.7 million that is growing at a 3.5 percent rate, the
need for all types of equipment is great and will continue to grow.

## Zambia

###### General Market Condition: No Restrictions

### *Source:* Report from CS Post (via E-Mail), 1 March 2002 {#source-report-from-cs-post-via-e-mail-1-march-2002 .unnumbered}

*Are there special restrictions or tariffs that apply to used medical
equipment that do not apply to new medical equipment?*

No. There are no special restrictions or tariffs that apply to
importation of used medical equipment that do not apply to new medical
equipment.

*Can public health institutions buy used or refurbished medical
devices?*

Yes. Public health institutions buy used or refurbished medical devices
however, they depend on donations and purchases through donor funded
projects. Public health institutions are under funded by the central
government.

*Is there a market for used or refurbished medical devices?*

Yes. There is a huge market for used or refurbished medical devices.

*If there is a market, what types of used or refurbished medical
equipment are in the greatest demand?*

There is a market for all types of used or refurbished medical
equipment. There are no facilities for local manufacturing so all
medical equipment is procured from abroad.

# Conclusions and Next Steps {#conclusions-and-next-steps .unnumbered}

Based on the summary of information contained in this report, it is
clear that U.S. exporters of pre-owned (used and refurbished medical
devices) face significant market restrictions above and beyond those
faced by exporters of new medical devices. These additional restrictions
take a variety of forms, but include the following:

-   Outright ban;

-   High tariffs or fees;

-   Ban on the purchase of pre-owned equipment by public institutions;

-   Requirements that after-sale service or technical support be
    provided;

-   Prohibition on the importation of pre-owned equipment that has not
    been refurbished;

-   Restrictions on the importation of equipment unless it has been
    refurbished by the original manufacturer or its authorized agent;

-   Special certification requirements;

-   Requirements for warranties;

-   Restrictions on the age of equipment; and

-   Ban on pre-owned equipment that competes with locally produced
    devices.

    To a large degree, these restrictions that target pre-owned
    equipment exist for the following reasons:

-   The problems that the importing countries have experienced with
    pre-owned equipment in the past;

-   The perception that the lower cost of used equipment does not
    justify the risk that the devices may not perform as well as new
    ones;

-   The concern that replacement parts or service may be difficult or
    impossible to obtain for pre-owned medical devices;

-   The perception that refurbished medical devices will perform better
    than pre-owned equipment that has not been refurbished;

-   The perception that medical devices refurbished by the original
    manufacturer will perform better than equipment refurbished by a
    firm that is not the original manufacturer;

-   The perception that pre-owned medical devices are of lower
    technology and result in lower quality healthcare; and

-   The concern that pre-owned equipment may pose safety risks since the
    U.S. market for pre-owned devices is largely unregulated and no FDA
    approval is generally required.

    Some of these concerns and perceptions are valid and some are not,
    but each country has the right to establish its own policies
    regulating the types of pre-owned devices it is willing to accept
    and the terms under which it will do so. As long as all countries
    exporting products are treated equally and market access barriers do
    not violate any specific trade agreements, the restrictions are not
    likely to be successfully challenged.

    The U.S. pre-owned equipment industry has several on-going
    activities that may improve the market for U.S. exports by
    addressing the concerns and perceptions listed above:

-   One U.S. industry association, the International Association of
    Medical Equipment Remarketers and Servicers (IAMERS) has developed a
    code of ethics with which all members agree to comply. IAMERS
    responds to complaints against its members and on several occasions
    has removed member firms for failure to comply with its ethics code.
    IAMERS-associated firms, however, remain a small segment of the
    industry, and its membership is heavily dominated by firms focusing
    on the resale and servicing of imaging equipment.

-   A joint effort of IAMERS, FDA, and several new-product industry
    associations---the Advanced Medical Technology Association
    (AdvaMed---formerly the Health Industry Manufacturers
    Associations---HIMA), National Electrical Manufacturers Associations
    (NEMA), and the Medical Device Manufacturers Association
    (MDMA)---has led to a draft agreement for self-regulation of the
    pre-owned medical device industry in 1999. (*See Appendix B*).
    Approval of the draft agreement by FDA is pending in Spring 2001.

-   Several U.S. medical device original equipment manufacturers (OEMs)
    have established or are establishing units to buy back and
    remanufacture their own devices, which are then resold with a full
    warranty and service availability.

-   Many U.S. pre-owned medical device firms are now offering some type
    of warranty with the products they sell.

An important development relating to the international trade in used and
refurbished medical equipment occurred in May 2002. For the first time,
refurbished medical equipment was the subject of a workshop at the
Global Harmonization Task Force (GHTF) Conference.

The GHTF is a voluntary group of representatives from national
medical-device regulatory authorities and the regulated industry. The
GHTF is comprised of representatives from five founding members
(Australia, Canada, the European Union, Japan, and the United States).
The purpose of the GHTF is to encourage convergence in regulatory
practices. The primary way in which this is accomplished is via the
publication and dissemination of harmonized guidance documents on basic
regulatory practices. The GHTF also serves as an information exchange
forum through which countries with medical device regulatory systems
under development can benefit from the experience of those with existing
systems and/or pattern their practices upon those of GHTF founding
members.

At the Ninth GHTF Conference, which took place in Singapore, May 12--16,
2002, a workshop focused on the "Regulation and Supply of Refurbished
Medical Devices." Although no report was issued by the workshop, the
session was important for bringing increased attention to refurbished
medical devices. Copies of the presentations made at Ninth Conference,
including those from the workshop on refurbished medical devices, are
available at the GHTF web site:

http://ghtf.org

In order to continue encouraging discussion of issues relating to the
international trade in pre-owned medical devices, the Department of
Commerce (DOC) will continue to update this report annually. We will
continue to ask each DOC Foreign Commercial Service office to review the
report as it relates to its country, checking it for accuracy and
updating it as necessary. We are also requesting U.S. industry
associations and firms involved with the sale of pre-owned medical
devices to review this report and to inform us if their experience
confirms or contradicts the information it contains.

# Appendix A Markets for Which No Information Was Available {#appendix-a-markets-for-which-no-information-was-available .unnumbered}

For the listed markets, there were no relevant ISA or IMI reports
discussing pre-owned equipment or import regulations for medical devices
and the U.S. Foreign Commercial Service post in that country did not
provide a response to OMMI's cable requesting information.

Markets with No Available Information

  ----------------- ----------------- ----------------- ------------------
  Abu Dhabi         Comoros           Latvia            Rwanda

  Afghanistan       Congo             Lebanon           St. Kitts and
                    (Brazzaville)                       Nevis

  Albania           Congo (Kinshasa)  Lesotho           St. Lucia

  Algeria           Cote D'Ivoire     Libya             St. Vincent & the
                                                        Grenadines

  Andorra           Cuba              Liechtenstein     Samoa

  Angola            Cyprus            Lithuania         San Marino

  Antigua and       Djibouti          Macedonia         São Tome and
  Barbuda                                               Principe

  Armenia           Dominica          Madagascar        Seychelles

  Azerbaijan        Equatorial Guinea Maldives          Sierra Leone

  Bahrain           Eritrea           Mali              Slovakia

  Belarus           Estonia           Malta             Solomon Islands

  Benin             Fiji              Marshall Islands  Somalia

  Bhutan            Gambia, The       Mauritania        Sudan

  Bosnia and        Georgia           Mauritius         Suriname
  Herzegovina                                           

  Brunei            Grenada           Micronesia        Swaziland

  Bulgaria          Guinea-Bissau     Monaco            Tajikistan

  Burkina Faso      Guyana            Mongolia          Togo

  Burma             Iran              Namibia           Tonga

  Burundi           Iraq              Nauru             Tuvalu

  Cambodia          Ireland \*        Niger             Vanuatu

  Cape Verde        Korea, North      Palau             Zimbabwe

  Central African   Laos              Qatar             
  Republic                                              
  ----------------- ----------------- ----------------- ------------------

\* Although specific information is lacking, general rules of the
European Community apply.

Source: U.S. Department of Commerce

# Appendix B Proposed Voluntary Self-Regulation of the Pre-Owned Medical Device Industry {#appendix-b-proposed-voluntary-self-regulation-of-the-pre-owned-medical-device-industry .unnumbered}

#### Background

In 1999, a joint effort of the American Association of Medical
Instrumentation (AAMI), the Emergency Care Research Institute (ECRI),
the International Association of Medical Equipment Remarketers and
Services (IAMERS), the U.S. Food and Drug Administration (FDA), and
several new-product industry associations---the Advanced Medical
Technology Association (AdvaMed---formerly the Health Industry
Manufacturers Associations---HIMA), the National Electrical
Manufacturers Associations (NEMA), and the Medical Device Manufacturers
Association (MDMA)---led to a draft agreement for self-regulation of the
pre-owned medical device industry. The proposed self-regulation included
voluntary labeling that would have tracked the pre-owned equipment,
registration of medical device resellers, and mandatory FDA review of
medical devices when original specifications had been modified in any
way. The draft agreement also called for a system for distributing
recall and hazard notices.

#### Status of the Proposal

The draft proposal was submitted to the FDA in Fall 1999. No action was
taken by the FDA at that time.

In June 2001, a spokesperson for the FDA indicated that review of the
proposal had been set aside temporarily in order for the agency to focus
on issuing guidance for the re-use of single use devices (SUDs), which
was believed to raise greater safety concerns. The FDA spokesperson
anticipated at that time that the agency would soon return to the matter
of the self-regulatory scheme. He indicated that the FDA did not intend
to publish a regulation implementing the voluntary regulatory system,
but rather to issue a Guidance Document explaining the application of
the Food, Drug, and Cosmetic Act to remarketing and endorsing the
voluntary proposal. As a first step, the FDA was apparently planning to
encourage the organizations that originally drafted the proposal to move
forward with establishing the third-party registry that would make
hazard, recall, and safety-related service notices available to
customers of participating re-sellers.

As of September 2003, the FDA has not issued such guidance.
Conversations that this writer has had with some of the organizations
involved in the drafting of the proposal suggest that the proposal has
lost organizational momentum. Many of the people directly involved in
the drafting have moved on to new positions or retired, and there seems
to be little interest in reviving the proposal.

#### Details of the Proposed Voluntary System of Self-Regulation

Under this proposed voluntary system of self-regulation, the
participating organizations would have labeled the used equipment they
service or remarket with the following information:

-   The name of the servicing or remarketing organization;

-   A toll-free telephone number or other contact information for the
    organization;

-   Service documentation describing the work performed using standard
    terminology (*see below*);

-   The date the work was performed and/or the date the transaction was
    completed; and

-   The appropriate Device Condition code (*see below*).

The proposed voluntary regulations defined 12 key terms relating to
activities that could be undertaken as part of the equipment
refurbishing process. The service documentation included on the label
would have had to use this terminology. These terms included the
following:

*Calibration*---is the checking and adjusting of a device's functions in
a quantitative manner, to make those functions conform, within a
specified tolerance to an identified standard.

*Cleaning*---is the removal of ordinary dirt or debris.

*Cosmetic Restoration*---is the restoration, or partial restoration,
repair or replacement of any components of the device that do not have a
direct effect on the device's functional performance or safety.

*Decontamination*---is the use of physical or chemical means to remove,
inactivate, or destroy pathogenic organisms on a surface or item to the
point where they are no longer capable of transmitting infectious
particles and the surface or item is rendered safe for handling, use, or
disposal.

*Installation*---is the setting of a device, or a hardware or software
component of a device, into its proper position and making it ready for
use according to the manufacturer's specification.

*Performance Verification*---is testing conducted to verify that the
device functions properly and meets the performance specifications; such
testing is normally conducted during the device's initial acceptance
testing.

*Preventive Maintenance*---is the inspection, cleaning, lubricating,
adjustment or replacement of a device's nondurable parts. Nondurable
parts are those components of the device that have been identified
either by the device manufacturer or by general industry experience as
needing periodic attention, or being subject to functional deterioration
and having a useful lifetime less than that of the complete device.
Examples include filters, batteries, cables, bearings, gaskets, and
flexible tubing.

*Remarketing*---is the act of facilitating the transfer of ownership of
a medical device by sale, gift, or lease.

*Repair*---is the restoration of the device to its original level of
functional performance and safety after it has malfunctioned or
sustained damage.

*Safety Testing*---is testing conducted to verify that the device meets
the safety specifications; such testing is normally conducted during the
device's initial acceptance testing.

*Scheduled (Planned) Maintenance*---consists of some or all of the
following activities: cleaning; decontamination; preventive maintenance;
calibration; performance verification; and safety testing.

*Service*---consists of some or all of the following activities:
installation; cleaning and/or decontamination; preventative maintenance;
calibration; performance verification; safety testing; the repair of
performance defects; repairs of safety defects; and cosmetic
restoration. This does not include activities that would result in
remanufacturing as that term is used in the FDA's Quality System/Good
Manufacturing Practices regulation.

Two Device Condition codes were defined for use on the label:

*DC 1*---Device may have received cosmetic restoration but otherwise is
in as is/unknown condition. Prior to use, device must be checked for
proper performance and safety.

*DC 2*---Device is performing properly and safely and is ready for
clinical use. If installation is required, the device must be checked
again after installation. For devices labeled DC 2, users and purchasers
should refer to the service documentation for additional information on
the service(s) performed.

Another key element of the voluntary regulations included the
establishment of a registry operated by a third party. The purpose of
this third-party registry was to make hazard, recall, and safety related
service notices available to all participants. Remarketers would have
been obliged to make information on FDA and manufacturer hazard, recall,
and safety related service notices available to their customers.

[^1]: This includes some double counting---information was available for
    the European Union, which can be considered a single market from the
    viewpoint of import regulations, as well as for 13 of the 15 EU
    member countries. Thus the count of 104 includes the EU as a whole
    plus 13 of its member countries.

[^2]: For several of these markets, however, it is safer to say that
    there are no reported restrictions since available reports either do
    not mention restrictions on pre-owned medical equipment when
    discussing the import regime for medical devices or simply indicate
    that authorities permits the importation of used equipment generally
    without a specific reference to medical devices.

[^3]: The use of the CE Mark has been required since 1995. Medical
    devices without the CE Mark legally sold to a customer in a EU
    member state before that year can be freely resold inside the EU,
    but identical equipment originally sold to users in other markets
    cannot now enter the EU. In the short term, this discriminates
    against vendors trying to sell pre-owned devices into the EU. Over
    the longer run, however, this problem will be resolved as equipment
    approved for sale in EU-member countries before the use of the CE
    mark becomes too old or out-of-date to be marketable.

[^4]: The requirement for re-registration is sometimes confusingly
    described as treating used devices on the same terms as new devices,
    i.e., because new devices are subject to registration, so are used
    devices.

[^5]: Because the United States does not export to itself, the
    population of the U.S. export market is equal to world population
    minus U.S. population, about 5.8 billion.