Medical Device Regulatory\
Requirements for

Peru

**Disclaimer:** The information contained on this website is derived
from public sources and is current to the best of our knowledge. For
detailed and definitive information about a country's laws and policies,
the government of the country concerned should be consulted. *See*
Update at end of profile.

**Overview**

Both the public and the private sector provide health care in Peru. The
public sector health services providers are the Ministry of Health
(MOH), the Social Security Service (ESSALUD) and the Armed Forces
hospitals. Private sector providers include profit and non-profit
clinics. Public institutions care for about 75 percent of existing
patients.

Public health, social security and armed forces hospitals are only
allowed to purchase new medical equipment and devices while private
sector clinics may purchase new or refurbished medical equipment and
devices. (*See below for more information on refurbished medical
equipment).*

**Regulatory Agency**

The Directorate General of Pharmaceuticals, Inputs and Drugs (Dirección
General de Medicamentos, Insumos, y Drogas or DIGEMID) of the Ministry
of Health is the regulatory agency for the health care sector. The legal
framework regulating the registration requirements for medical equipment
and devices are established in Law No. 26842 dated July 20, 1997.

**Regulations**

It is mandatory to obtain a sanitary registry or "Registro Sanitario" to
market medical equipment in Peru or to participate in a bidding process.
This registration must be submitted to Peruvian customs each time the
same equipment is imported.

To request the Registro Sanitario, the following steps should be
considered:

(a). The importer or dealer must be legally registered and obtain a tax
identification number known as the \"Registro Único del Contribuyente"
or "RUC."

\(b\) The interested company must fill out a form called a registration
request called the "Solicitud de Inscripción," providing the following
information:

-   Subject of the request

-   Name of the medical equipment, device or material

-   Presentation format

-   Type of material used in the primary and secondary packing/packaging

-   Country of origin

-   Name, address, and RUC of local company or authorized representative
    (Use of local agents is of great importance in Peru, as tenders are
    only issued to locally-based distributors. *See below* for more
    information on the use of local distributors).

**Required Documentation**

The following documents must be attached to this request:

1.  Certificate of Free Sale (CFS). The CFS is issued by the U.S.
    authority (FDA or the State Department of Health) stating that the
    equipment is freely sold and marketed in the U.S. according to
    federal rules and regulations. This document must include the name
    of the U.S. manufacturer providing the specifications of the
    equipment and its accessories. If the accessories or models were not
    included in the CFS, the interested company must attach a letter
    from the manufacturer giving the codes, models and accessories.

2.  Protocol Analysis or Certificate of Analysis. This document is
    authored by the manufacturer's quality control division. This
    document must include results from applicable tests, including
    microbiological and chemical tests, skin sensitivity and /or human
    biocompatibility (according to the product) as well as the ethylene
    oxide waste control, or any other sterilization method used.

> Following are additional documents required for medical devices:

-   For surgical and dental instruments: chemical composition

-   For dental materials: qualitative components

-   For stainless steel instruments: number of the steel, the hardness,
    and any other relevant tests. The DIN or ISO codification must be
    indicated.

3.  Operation Manual. Instructions for use must be specific for each
    model.

4.  Catalogs. Catalogs must provide technical specifications, and
    accessories lists, wherever applicable.

5.  Labeling Requirements. Labeling must include a product description,
    as well as information on packaging material, storage conditions,
    lot number, expiration date, importer's data, address and RUC.

Additional information:

-   All the above-mentioned documents must be translated into Spanish
    language (a notarization is not required.)

-   The certificate of free sale, the protocol analysis/analysis
    certificate and other documents should not be older than two years.

-   The registration fee per piece of equipment, device and material is
    approximately US\$100 and is valid for a 5-year period.

According to law 26842, DIGEMID must issue the approval of the
registration within approximately seven working days. Nevertheless,
approvals have been reported to take thirty to sixty days.

**Refurbished/Used Equipment**:

There is no explicit restriction on the import of refurbished medical
equipment in Peru. However, as a matter of practice over recent years,
DIGEMID is not issuing the "sanitary registry" for refurbished medical
equipment imported by local companies. Physicians requiring equipment
for their own use have been allowed to import one type of refurbished
equipment every year.

**Import Duties and Taxes**

Tariffs on medical equipment include an *ad-valorem* custom duty of 7
percent and a 19 percent value added tax (VAT).

Follows is an example of the landed cost of \$1,000 worth of medical
device merchandise into Peru.

CIF Value of Merchandise 1,000.00

Ad-valorem tariff duty (4%) 40.00

Sales tax base 1,040.00

Value added tax (19%) 197.60

Custom broker charges (1-2% FOB value) 100.00

Port charges (approx 3%) 30.00

Handling charges (\$20-\$40) 20.00

Bank charges-letter of credit

(3% of FOB, min fee\$277) 277.00

Landed cost (US\$ 1,664.60

**Distribution**

The most common method of distribution is the appointment of a qualified
representative. Appointing an agent or distributor is advisable if the
company is serious about developing the market on a sustained basis. At,
present, U.S. companies are successfully locating qualified local
agents.

## Government Purchases[^1]

Public tenders are usually published in the main Peruvian newspapers
(*El Peruano* and *El Comercio*.) Government hospitals of the Ministry
of Health, in an effort to ensure transparency for government tenders,
is currently using the United Nations Office for Project Service (UNOPS)
to notify potential suppliers. The social security agency, ESSALUD,
mostly buys centrally through its procurement office.

Public sector purchases must be carried out in accordance with
Government Procurement Regulations (Ley de Contrataciones y
Adquisiciones del Estado) and the budget of each agency. According to
the procurement regulations, which entered in force in March 2001 a
preference exists for domestic suppliers.

Other documents required when responding to government tenders include:

Representation Agreement, issued by the manufacturer indicating the name
of their representative in Peru. The agreement must be legalized by a
Peruvian Consulate in the United States and registered by the Peruvian
Ministry of Foreign Affairs.

Certificate of Good Manufacturing Practices, issued by the foreign
government authority (FDA or State Department of Health)

Proof of conformity with ISO 9001 and ISO 13485.

Proof of conformity with electrical standards IEC-601-DINVDE0750-1 or
its international equivalent as applicable.

## Update

In December, 2005, the United States and Peru completed negotiations a
Trade Promotion Agreement (Peru-TPA) that provides for equitable and
reciprocal trade liberalization between the two countries. For medical
equipment, 98 percent of U.S. industrial exports will receive duty-free
treatment immediately upon implementation of the agreement. The only
products not subject to immediate tariff elimination are orthopedic and
fracture appliances. Duties on these products will be eliminated over
five years. The agreement also allows for free importation of
remanufactured goods with tariffs on these goods eliminated over ten
years. For more information and updates on the U.S.-Peru Trade Promotion
Agreement, please visit
http://www.ita.doc.gov/td/tradepolicy/fta_peru.html

**Contact Information**

**Government Agencies**

Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)\
Ministerio de Salud\
Av. Arenales 1302 Oficina 201\
Jesus Maria, Lima 11, Peru\
Phone: (51-1) 265-8780 ext 237

Fax: (51-1) 471-6353

Contact: Dra. Amelia Villar, General Director

Contact: Dr. Anibal Diaz, Executive Director of Sanitary Authorizations

Web:
[www.minsa.gob.pe/infodigemid/](http://www.minsa.gob.pe/infodigemid/)

**Trade Associations**

Asociación de Clinicas Particulares

(Association of Private Clinics)\
Av. Dos de Mayo 1502, Of. 202\
San Isidro\
Lima 27, Peru\
Phone: (511) 422-4024\
Fax: (511) 441-9546\
Contact: Mr. Gonzalo Garrido Lecca, President

> Dr. Percy Bailett, General Administrator

E-mail: achp@ccl.com.pe

Comité de Productos para la Salud y Ciencias Afines - Cámara de Comercio
de Lima

(Health and Related Sciences Products Committee -- Lima Chamber of
Commerce)\
Gregorio Escobedo 398\
Jesús María\
Lima 11, Peru\
Phone: (5-1) 463-3434

Fax: (51-1) 421-4709

Contact: Sr. Emilio Leighton, President

Web: [www.camaralima.org.pe](http://www.camaralima.org.pe/)

E-mail: <comsalud@camaralima.org.pe>

## The Commercial Service in Lima, Peru

Flora Muroi, Commercial Specialist

Phone: 51 1 434 3040

### Fax: 51 1 434 3041

[Flora.Muroi@mail.doc.gov](mailto:Rosario.Llontop@mail.doc.gov)

[www.buyusa.gov/pe/en](http://www.buyusa.gov/pe/en)

N. Gerard Zapiain

May 2006

[^1]: Public tenders are only issued if the value of the purchase
    exceeds 450,000 soles (\$136,000). Otherwise, purchases are made
    directly by the government.