# China Medical Device Registration <http://www.ita.doc.gov/td/mdequip>

Prepared by: Jay Biggs\
International Trade Specialist\
U.S. Department of Commerce

> Office of Health and Consumer Goods
>
> \(202\) 482 - 4431\
> jay_biggs@ita.doc.gov
>
> August 2004

## Disclaimer

The information contained in this profile is intended for basic market
planning. While these profiles are updated periodically, many regulatory
systems are subject to change. Companies are strongly encouraged to
contact in-country representatives who are familiar with the most
current regulatory environment.

Translations of laws and regulations are unofficial.

Web links were current in June 2004.

## Executive Summary

China's regulatory system for medical devices is relatively new; the
basic law was promulgated in 2000, and key implementing regulatory
issues still being developed. China's State Food and Drug Administration
(SFDA), is the primary agency responsible for regulating medical
devices, and information about current regulations, along with official
forms are posted on SFDA's website in Chinese. Chinese Customs
authorities and Provincial health bureaus also play significant roles in
the regulation of medical devices.

Prior to registration in China, devices manufactured in the Unites
States must be approved for sale in the United States by the U.S. Food
and Drug Administration (FDA). The FDA Certificate to Foreign Government
must be submitted with the registration application. Chinese labeling
requirements require that Chinese language labels be attached to all
products, and that these labels must be submitted with the registration
application.

To be sold in China, medical devices must be registered with Chinese
health authorities. This involves not only sample product testing but
also factory audits. This registration process is somewhat opaque, and
timelines are often longer than specified in the regulations. Fees and
testing requirements depend on the risk category of the product being
reviewed.

China issues registration certificates and licenses in the name of the
device manufacturer, not to the agent or distributor. Therefore,
companies should arrange for the agent/distributor to hand over the
certificates or licenses. U.S. medical device firms have found it
difficult to conduct registration from overseas due to communication
problems and other requirements, such as the need to designate a local
after‑sale service provider, or to provide samples to Chinese testing
labs. Therefore, most U.S. firms authorize a locally based
representative, or distributor to manage the product registration or
other necessary approvals.

The manufacturer may sell the product through multiple distributors and
can amend the registration naming a different distributor as
representing the company. Nonetheless, U.S. companies are advised to
obtain local legal counsel before signing distributor agreements to
ensure that their legal rights under Chinese law are protected.

## Regulatory Agencies

There are three Chinese agencies that have regulatory roles for imported
medical equipment. Depending on the product being exported to China, a
company will need to register with the State Food and Drug
Administration (SFDA), and may be required to receive approval from the
Ministry of Health (MOH), or the General Administration of Quality
Supervision, Inspection and Quarantine of the People's Republic of China
(AQSIQ). In addition, for medical device products which fall into the
category of pressure vessels, Chinese Customs requires certificates
issued by the Safety Quality Licensing Office for Import Boiler and
Pressure Vessels (SQLO) of the State Administration for Technical and
Quality Supervision, in addition to SFDA and AQSIQ certification.

**State Food and Drug Administration:**

Regulation of medical devices falls under the jurisdiction of the State
Food and Drug Administration. This government ministry is roughly
equivalent to the U.S. Food and Drug Administration, and was previously
known as the State Drug Administration. All imported medical devices
must get a registration certificate from SFDA before being sold in
China. The SFDA has a comprehensive system for medical device
registration and inspection, which includes product type testing and
factory audits.

**Ministry of Health:**

The Ministry of Health (MOH) is in charge of drafting laws, regulations,
and policies related to public health, overseeing the administration of
Traditional Chinese Medicine, and for administering China's rural health
insurance system. MOH responsibility for the procurement of medical
equipment on the provincial level includes overseeing the bidding and
tendering process for medical devices and pharmaceuticals sold to State
run hospitals.

Chinese hospitals are divided into for-profit and nonprofit units and
allowing patients to choose hospitals. Nonprofit units may enjoy
preferential tax policies while for-profit services may set their own
prices but must pay taxes. For-profit hospitals, which include
Sino-foreign joint ventures and clinics, must apply to the MOH for
approval and may only treat self-funded patients. In addition, joint
ventures must use advanced equipment and technology and offer services
that local hospitals cannot.

**General Administration of Quality Supervision, Inspection and
Quarantine:**

The General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China (AQSIQ) is tasked with
overseeing inspection, quarantine, and establishing the technical
standards of goods for import and export. AQSIQ maintains responsibility
for certifying electrical safety for a wide variety of products,
including some electro-medical devices. Upon certification, products
receive a \"China Compulsory Certification" (CCC), mark which serves as
evidence that the catalogue-covered products can be imported, marketed
and used in China.

Websites for Chinese Health Regulatory Agencies

  ------------------------------------ ------------------------------------------------
  Agency                               Website

  State Food and Drug Administration   http://www.sfda.gov.cn/eng/

  General Administration of Quality    <http://www.cnca.gov.cn/download/english.html>
  Supervision, Inspection and          
  Quarantine - Certification and       
  Accreditation Administration         

  Ministry of Health                   [www.moh.gov.cn](http://www.moh.gov.cn/)
  ------------------------------------ ------------------------------------------------

## Laws and Regulations

The *Regulations for the Supervision and Administration of Medical
Devices,* enacted in April 1, 2000, is the fundamental law governing
China's health sector. The law has been amended several times, and
recent changes to various sections can be found on the SFDA website.

## Definition of Medical Devices

According to Article 2 of the *Directive to Medical Device
Administration*, a "Medical devices" refer to those instruments,
equipment, tools, materials and other objects, including the software
attached to them, that are designed to be

used either independently or in combination on human body. These devices
are used

for:

1\. Prevention, diagnosis, treatment, monitoring or remission of
diseases;

2\. Diagnosis, treatment, monitoring, remission or compensation of
injury or physical disability;

3\. Research, replacement or adjustment of anatomical or physiological
process;

4\. Control of pregnancy.

Basically, the effect of these devices on human body is not achieved
through means of pharmacology, immunology or metabolism; though they
might be resorted to in order to bring about certain supplementary
effect.

## Registration Procedures

### Who Submits the Registration Application

In contrast to many other Asian countries, China issues registration
certificates and licenses in the name of the device manufacturer, not to
the agent or distributor. Therefore, companies should arrange for the
agent/distributor to hand over the certificates or licenses.

### What Medical Devices Need to be Registered

China's *Regulations for the Supervision and Administration of Medical
Devices* sets out three classifications for medical devices(Class I --
III). Medical devices in all three classes need to be registered.
Domestic manufactured products register with Provincial Health Bureaus,
while imported medical devices must register with the State Food and
Drug Adminstration. Below are the general definations of each class.

Class I Medical Devices are those for which safety and effectiveness can
be ensured through routine administration;

Class II Medical Devices are those for which further control is required
to ensure their safety and effectiveness

Class III Medical Devices are those which are implanted into the human
body, or used for life support or sustenance, or pose potential risk to
the human body and thus must be strictly controlled in respect to safety
and effectiveness.

### What Risk Category is the Device?

SFDA has a document (*Regulation for Medical Device Classification*),
which provides general guidance on how to determine which classification
a device falls under. SFDA also has a classification catalogue for
medical devices (in Chinese) which provides more information regarding
which classification a device falls under. This catalogue is organized
in a manner similar to, but not the same as, the Global Medical Device
Nomenclature System. If a company is unable to determine their
classification, they need to submit their product information to SFDA's
classification office (in Chinese). The U.S. Department of Commerce's
Commercial Service staff in Beijing can help companies in getting this
information to the proper SFDA official.

### How to Demonstrate Conformance with Chinese Standards

Chinese law requires each industrial product to have a Chinese national
standard. The Chinese national standard is usually the same as the
relevant international standard, although sometimes with minor
modifications. Medical devices type testing must be based upon the
Chinese national standard. However, if there is no national standard, an
industry standard, or a company-specified standard may be used. Chinese
testing laboratories work with companies to ensure that their
company-specific standard are in-line with relevant national standards.

### What Forms are used to apply for Device Registration?

The form used to apply for device registration can be found on the China
Medical Device Information Network website
([http://www.cmdi.gov](http://www.cmdi.gov/)). Although the website has
an English version, the application form can only be found on the
Chinese version.

Commonly Needed Forms Related to Medical Device Registration in China

  ------------------ --------------------------------------------------------------------------- -----------------------
  Name of the Form   Link to Downloadable Form                                                   General Purpose of the
                                                                                                 Form

  Application for    [http://www.cmdi.gov.cn:5555/sbl/bszn/setup.exe]{.underline}                To register medical
  the Registration                                                                               with the State Food and
  of Medical Devices                                                                             Drug Administration

  CCC Application    [www.cqc.com.cn/index-e.htm](http://www.cqc.com.cn/ccc/catalogureeng.pdf)   To apply for CCC Mark
  Online Guide                                                                                   
  ------------------ --------------------------------------------------------------------------- -----------------------

### How Much Does Registration Cost?

Registration costs RMB 3,000 for all classes of medical devices. This
does not include the cost of having products type-tested at SFDA
designated device inspection institutes, which can range from \$1,000 to
\$4,000 per product for devices with power supply, and from \$400 to
\$1,000 per product for devices without power supply. This does not
include translation costs or consultant fees.

Note: Product licenses must be renewed every [four years]{.underline}.

### What Information is Asked for During the Registration Process?

The following items are to be submitted with all applications:

-   Business license

    -   This includes manufacturer\'s incorporation documents which
        contains registration number, company address, investor names,
        addresses, zip codes, etc., medical device manufacturing permit
        and other legal documents which can prove the legitimate
        qualification of the manufacturer.

    -   There are two types of agents: registration processing agents,
        and after sales agents.

        -   If an agent is processing the registration for the
            manufacturer, the registration application must include a
            letter of authorization stating that agent is the sole agent
            for the company's registration and that the manufacturer is
            responsible for the product.

        -   The manufacturer must also specify the after-sales agent(s)
            in an after-sales authorization letter. The after-sales
            agent(s) is responsible for sales and after sale service,
            and must be located inside China. Two letters have to be
            submitted to SFDA as part of the after-sales authorization
            registration process: a letter from the manufacturer
            (clarifying the product name) and a letter of promise from
            the agent. If, at a later date, a manufacturer wants to
            change its designated agent(s), it must inform SFDA. When a
            manufacturer wants to use more than one agent, Authorization
            Letters need to be issued to all the Chinese agents.

-   Manufacturing authorization document in the country of origin

    -   This includes documents showing proof of product marketing
        approval issued by the government of country (or region) of
        origin (such as 510K issued by FDA, PMA, or CE certificate
        issued by the European Union Notified Body).

-   Product standard

    -   This includes the quality standards the product must meet before
        shipment from factory, such as a Declaration of compliance with
        adopted standards, either ISO, IEC or other standards technical
        requirements of the products.

    -   Product introduction: component, applications, materials, volume
        of product, sterilization method;

    -   Characteristics of the product: sterile, non‑thermogenic, etc.;
        disposable, self‑destroying model, reducing cross‑infection;
        factory standards

-   Operation manual of the product

    -   The operation manual of medical devices shall implement the
        national standards provided in "Operation Manual for Industrial
        Products\--General provisions". In accordance with the specialty
        of the medical devices , the following contents shall be
        included:

        -   Name of Product, Name, Address, Postal Code and Tel. of the
            Manufacturer；

        -   Registration number of the products;

        -   Applied product standards;

        -   The main structure, performance, specification of the
            Products；the usage, scope of application, contraindication,
            precautions, cautions and suggestions of the Products;

        -   Interpretation of the figures, logos, abbreviations, etc. of
            the labels and marks;

        -   Illustration and graphic expression of the Installation and
            Operation;

        -   The Maintenance methods, special storage methods and length
            of life of the Products；

        -   other necessary contents specified in the Product Standards.

-   Type test report: issued by a medical devices quality test agency
    recognized by the State Food and Drug Administration within the
    recent one year (for Class II and Class III products).

    -   Note that some high tech medical devices are eligible for
        registration before the results of testing are complete
        (Test-after-Registration)[^1].

    -   Certain laboratory equipment is also exempt from type -- testing
        requirements[^2].

    -   For more information about these exemptions, along with a more
        in depth discussion of the registration requirements above, go
        to
        (http://www.sfda.gov.cn/webportal/portal.po?UID=DWV1_WOUID_URL_45649090&TOC=COLUMN_45649090&OBJ=45649014)

-   Quality guarantee letter: stating the product is of the same quality
    as those sold in the U.S.

-   Manufacturer or agent's declaration that the data and information
    submitted in the registration document are accurate.

### How Long Does It Take for an Application to be Processed?

On August 9, 2004, SFDA promulgated new regulations that significantly
changed the medical device registration system by combining evaluation
of the standards used for the product with the dossier evaluation (i.e.
testing) process. Previously, a manufacturer had to submit a dossier
with company specified standards (specification validation) to SFDA.
Once SFDA approved the specification validation dossier, essentially
confirming that the company's testing specifications were accurate, then
SFDA would begin the testing process and issue the import licence.

Now, SFDA sends the dossier, which includes the technical specifications
along with the official testing reports (based on the company specified
standards) to the Medical Device Evaluation Center to review. If the
Evaluation Center finds no problems with either the company specified
standards, or the results of the tests based on those standards, it
reports back to SFDA, which issues the import licence. The Evaluation
Center review, and SFDA approval process takes about four months, which
is an improvement over the from 6 --12 month timeline under the previous
system. However, under the new system there is the possibility that
because testing is done before SFDA validates the manufacturers
standards, SFDA may reject the standards and require that the
manufacturer re-submit the entire dossier with revised standards.

**Labeling Requirements**

On July 8, 2004, SFDA issued a regulation titled "Provisions for the
Instructions, Labels and Package of Medical Devices" which lays out
requirements for labeling. Medical Devices imported into China must be
labeled in Chinese, and include the registration certificate number,
product features, and the scope of usage for the product. These labels
should be affixed to products before going through customs. The
regulation also required that the consumers should be informed of the
related symptom, things to be aware of, and other needed warnings. On
perishable products, language or marks noting \"perishable use\" should
be attached, and validity dates should be marked products that need to
be used within certain period.

This regulation has a number of prohibitions again absolute expressions
on efficacy. These include \"best effect of treatment\", \"Full recovery
guarantee\", \"Immediate effect\", \"Without toxicity and side-effect\".
Other prohibitions include language providing guarantees such as \"Money
back if not effective", \"highest technology\", \"most scientific\",
\"most advanced\" and \"the best\". In addition, the specifications,
labels and marks of medial devices can not state cure rate or efficacy
rates, comparisons to the efficacy and safety of one manufacturer's
products with another's. Making use of the name or image of any firm's
or individual's for the purpose of approval or recommendation is not
allowed, nor can devices have labels contain such expressions which make
people feel that they have attracted certain disease, or which mislead
people into feeling that they would contract a certain disease, or their
disease could get worse by not using this medical device. U.S.
manufacturers are advised to work with their Chinese distributors
regarding labeling issues.

## Importation Documentation and Procedures

### Official Chinese Standards

Chinese law requires each industrial product to have a Chinese national
standard. The Chinese national standard is usually the same as the
relevant international standard, although sometimes with minor
modifications. Medical devices type testing must be based upon the
Chinese national standard. However, if there is no national standard, an
industry standard, or a company-specified standard may be used.

***Clinical Trials***

For first-time registration with SFDA, a company is required to provide
a testing report for the product by a Chinese lab and clinical trial
report (for certain high risk products) with clinical data based on the
clinical trials from two medical institutions. The company is also
required to submit a product standard according to China\'s "Product
Regulation Standard", for SFDA\'s record. Although labs are required to
complete their testing within one month, this often takes between 4 -- 5
months to complete. SFDA is trying to address this issue, and is
developing new regulations on clinical trials. Click here for an
unofficial translation of regulations on clinical trials that went into
affect April 2004.
(http://www.sfda.gov.cn/webportal/portal.po?UID=DWV1_WOUID_URL_45649039&TOC=COLUMN_45649039&OBJ=45649072ORIGURL=/webportal/portal.po?UID=DWV1_WOUID_URL_43879537)

If a laboratory can not test a device (due to the lack of a Chinese
National Standard, or because a company-specific standard beyond the
lab's testing capability), SFDA will accept tests conducted in the
product's country of origin. However, U.S. companies have noted that in
the past these laboratories have required that the company-specific
product standard (product specifications, testing methods and
specifications) be submitted for review and approval prior to testing
being done by the lab. In some cases, labs have insisted that the
company-specific product standard did not meet their format, and have
tried to get companies to pay a fee to have the standard re-written in a
manner that makes it possible for the lab to do the test itself. In the
past, laboratories often attempted to perform the required testing
without the proper facilities or knowledge, which were not always
accepted by SFDA. In many cases, SFDA found those tests to be
insufficient and requires new tests.

SFDA has certified ten testing laboratories as technologically competent
to perform the required tests in an effort to alleviate these problems.
Appendix 1 lists the ten Chinese laboratories accredited by China's
State Food and Drug Administration to perform product tests for various
types of medical devices, and which type of device they are accredited
to test.

***Comments:*** Based on anecdotal reports received by the U.S.
Commercial Service office in Beijing, companies preparing to register a
medical device in China should be mindful of the following
considerations:

Companies have found it difficult to conduct registration from overseas
due to communication problems and other requirements, for instance, the
need to designate a local after-sale service provider, or to provide
samples to testing centers in China. Accordingly, it is recommended that
U.S. companies authorize a locally-based representative or distributor
or a specialized agent firm to manage the product registration or other
necessary approvals.

SFDA requires that the local registration specialist have adequate
technical knowledge about the product being registered, in order to
allow effective and efficient communication. Registration specialist may
be asked to answer technical questions about products during the course
of testing at the designated testing center.

***Bidding and Tendering Procedures - Ministry of Health***

The Ministry of Health (MOH) is responsibility for the procurement of
medical equipment on the provincial level includes overseeing the
bidding and tendering process for medical devices and pharmaceuticals
sold to State run hospitals.

Bidding and Tendering Requirements

-   In order to sell medical devices to State-owned hospitals, companies
    must go through a bidding and tendering process supervised by MOH.
    This process was introduced as a pilot program in 2003, and is
    gradually being expanded to cover a wider array of products and
    geographical regions.

-   In order to participate, a company must submit copies of the
    relevant product licenses, bidding documents (which sometimes
    includes providing samples) to tendering companies for review. After
    review by the tendering company's review panel, selected companies
    are then able to participate in a round of price negotiations. If a
    company accepts the pricing offer made by the tendering company,
    then they are deemed qualified bidder.

-   Becoming a qualified bidder is not a guarantee of sales. The final
    step in the bidding process is to enter into price negotiations with
    individual hospitals. In some tenders, bidders have to pay a fee in
    order to participate the bidding process, and in many cases,
    qualified suppliers have to pay a one to two percent service fee to
    the tendering company for every purchase they made through the
    tender.

> The Ministry of Health is in the process of introducing a new
> centralized purchasing system for high valued medical devices. This
> new bidding process will involve 3 rounds:
>
> 1\) Analysis of Technical Specification -- done by an Expert Panel
>
> 2\) Price Negotiation -- done by hospitals' selection committees
>
> 3\) Quantity negotiation with the individual hospitals - There will be
> no negotiation on prices, and both sides will have 7 days to sign a
> contract with on quantities and delivery details. According to the
> Ministry of Health, Hospitals will commit to a quantity, based on the
> consumption of the previous years. There will be a leeway of plus or
> minus ten percent.
>
> The target start date for bidding done with this system is 1st
> January, 2005. This new system will apply to 3A hospitals in the
> capital cities of 8 provinces (Beijing, Tianjin, Shanghai, Chongqing,
> Guangdong, Liaoning, Zhejiang, and Hubei).

Provincial Health Bureaus[^3]

Each provincial health bureau serves as the administrative authority for
hospitals in the area. These bureaus are also responsible for
determining how to allocate the distribution of major medical device
purchases. In order to operate medical devices, hospitals are required
to obtain three permission certificates: 1) equipment allocation
permission, 2) operation permission and 3) working staff permission.

AQSIQ - Product Registration & Certification

The General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China (AQSIQ) is tasked with
overseeing inspection, quarantine, and establishing the technical
standards of goods for import and export. In November 2001, regulations
for compulsory product certification were approved by the AQSIQ which
cover a variety of electro-medical devices. Referred to as \"China
Compulsory Certification" (CCC), this certification\--inclusive of a
certificate and a mark\--serves as evidence that the catalogue-covered
products can be imported, marketed and used in China. The CCC Mark is
administered by the China National Certification and Accreditation
Administration (CNCA), which designates the China Quality Certification
Center (CQC) to process CCC mark applications.

The following seven categories of electro-medical device products
require CCC certification:

> Electrocardiographs;
>
> Hemodialysis equipment;
>
> Extracorporeal blood circuit for blood purification equipment;
>
> Hollow fiber dialyzer;
>
> Implantable cardiac pacemakers
>
> Medical x-ray diagnostic equipment;
>
> Artificial heart-lung machine (including roller pump, pulsatile roller
> pump, bubble oxygenator, heart exchanger, water heating/cooling
> system, silicon rubber pump tube)

The application process for the CCC mark requires submission of numerous
technical documents, and can take sixty to ninety days or longer.
Manufacturers must submit product sample to an accredited laboratory in
China which can charge several thousand dollars. In addition to the
initial testing, CCC mark certification requires a factory inspection by
Chinese officials at the applicant\'s expense, as well as follow-up
inspections. Follow-up factory inspection can be done by local notified
bodies (NB) located in the country of the factory as long as these NB
has recognition agreement with AQSIQ. Component parts of a
manufacturer\'s finished products may in some cases also require CCC
certification. In those cases, the component manufacturer is generally
required to apply for the CCC mark. Also be aware that spare parts and
replacement parts shipments may in some cases require CCC certification,
or application for an exemption.

> There are five major steps in the CCC mark application process:

1.  *Application* - Submission of an application and supporting
    materials, including user guides, CB reports, EMC reports,
    regulatory labels and other information.

2.  *Type Testing* - A CNCA-designated test laboratory in China will
    test product samples.

3.  *Factory Inspection* - CQC will send representatives to inspect the
    manufacturing facilities for your product. They will inspect each
    factory producing your product (e.g. If your company manufactures
    Product Z in five separate factories, all of which ship product to
    China, you will need to have five separate factory inspections).
    Please note: Chinese inspectors will need U.S. visas to visit
    U.S.-based facilities. The U.S. State Department is now subjecting
    visa applications to a greater degree of scrutiny than in the past,
    and visa applicants are being advised to expect delays. These visa
    delays may slow your CCC mark application.

4.  *Evaluation* -- evaluation of certification results, and approval
    (or failure or retesting).

5.  *Follow-up Factory Inspection* - Manufacturing facilities for the
    product will be re-inspected by Chinese officials every 12-18
    months.

For more information on CCC mark requirements, go to the China Quality
Certification Center (CQC) site
[www.cqc.com.cn/index-e.htm](http://www.cqc.com.cn/ccc/catalogureeng.pdf)
The U.S. Department of Commerce also has an site which provides detailed
explanation of the process and requirements for obtaining a CCC mark
(www.mac.doc.gov/China/Docs/BusinessGuides/cccguide2.htm)

Text of Chinese Health Laws, Regulations, and Standards on the Web

  ------------------------ ---------------------------------------------------------------------------
  Law                      Web Site

  Regulations for the      http://www.sfda.gov.cn/en
  Supervision and          
  Administration of        
  Medical Devices          

  CCC Mark Requirements    [www.cqc.com.cn/index-e.htm](http://www.cqc.com.cn/ccc/catalogureeng.pdf)
  ------------------------ ---------------------------------------------------------------------------

If you have any additional questions about the medical device regulatory
market in China, please contact Mr. Jay Biggs of the U.S. Department of
Commerce, Office of Health and Consumer Goods at (202) 482 -- 4431 or at
jay_biggs@ita.doc.gov Additional medical device regulatory profiles on
various countries can be found on our website www.ita.doc.gov/td/mdequip

**Appendix 1: SFDA Accredited Laboratories for Medical Device Testing**

1.  **Beijing Medical Device Quality Supervision and Inspection
    Center**\
    *(Linear accelerators, biochemical analyzers, in vitro diagnostic
    reagents)*\
    Address: 2 Bei San Huan Zhong Lu\
    Beijing 100011\
    Tel: (86-10) 6201-3862\
    Fax: (86-10) 6202-5329

2.  **Wuhan Medical Device Quality Supervision and Inspection Center**\
    *(Ultrasound technology)*\
    Address: Yue Jia Zui, Zhong Bei Lu, Wuchang\
    Wuhan City, Hubei Province 430077\
    Tel: (86-27) 678-6706

3.  **Guangzhou Medical Device Quality Supervision and Inspection
    Center**\
    *(sterilization and hemodialysis devices and supplies)*\
    Address: 9 Ci You Jie, Ci You Xin Ma Lu\
    Guangzhou, Guangdong Province 510600\
    Tel: (86-20) 8737-0574\
    Fax: (86-20) 8739-0919

4.  **Jinan Medical Device Quality Supervision and Inspection Center**\
    *(Nuclear medicine devices)*\
    Address: 11 Jie Fang Lu, Jinan City\
    Shandong Province 250013\
    Tel: (86-531) 893-7921, ext. 264\
    Fax: (86-531) 893-7555

5.  **Tianjin Medical Device Quality Supervision and Inspection
    Center**\
    *(Orthopedic and physical therapy devices)*\
    Address: 201 Hong Qi Road, Nankai District\
    Tianjin 300191\
    Tel: (86-22) 2335-5845\
    Fax: (86-22) 2336-5845

6.  **Hangzhou Medical Device Quality Supervision and Inspection
    Center**\
    *(Optical devices, lasers, eyeglasses, contact lenses)*\
    Address: 23 Huan Cheng Dong Lu, Hangzhou\
    Zhejiang Province 310009\
    Tel: (86-571)704-8861\
    Fax: (86-20) 788-1112

7.  **Beijing Medical University Medical Device Quality Supervision and
    Inspection Center**\
    *(Dental materials)*\
    Address: 4 Da Hui Ci, Wei Gong Cun\
    Beijing 100081\
    Tel: (86-10) 6217-9977, ext. 2267

8.  **China Institute for the Control of Pharmaceutical and Biological
    Products Medical Device Quality Supervision and Inspection Center**\
    *(Implantable devices and materials)* Address: 2 Tiantan Xili\
    Beijing 100050\
    Tel: (86-10) 6701-7755, ext. 368\
    Fax: (86-10) 6702-0395

9.  **Shanghai Medical Device Quality Supervision and Inspection
    Center**\
    *(Other electromedical / electrosurgical devices)* Address: 154
    Minhe Road\
    Shanghai 200070\
    Tel: (86-21) 5663-5850\
    Fax: (86-21) 5663-1202

    **Shenyang Medical Device Quality Supervision and Inspection
    Center**\
    *(X-ray equipment)*\
    Address: 22 Zhonggong Beijie, Tiexi District\
    Shenyang, Liaoning Province 110026\
    Tel: (86-24) 2582-0298, ext. 3102\
    Fax: (86-24) 2582-0569

    **Appendix 2: U.S. -- China Joint Commission on Commerce and Trade
    (JCCT) Medical Devices & Pharmaceuticals Subgroup**

    The U.S. Department of Commerce regularly meets with SFDA officials
    to discuss medical device and pharmaceutical regulatory and
    reimbursement issues as part of the U.S. -- China Joint Commission
    on Commerce and Trade (JCCT). U.S. industry representatives also
    participates in these discussions, which are held on a regular
    basis. Attached is the report from the most recent meeting. [***Read
    the report***](http://ita.doc.gov/td/health/medical.html)

[^1]: These include X-Ray Computerized Topography; Positron Emission
    Computerized Topography; Single Photon Emission Computerized
    Topography; Extraneous Shock Wave Crusher; Color Ultrasonic
    Diagnostic Scanner; Large Laser Therapy Apparatus; Large X-Ray
    Diagnostic Equipment; Automatic Biochemical Analyzer； Cobalt 60
    Therapy Unit; Gamma Knife; Medico- electronic Linear Accelerator;
    Simulated Positioner; Magnetic Resonance Imaging System

[^2]: Exempt laboratory equipment includes: the electrophoresis
    apparatus、centrifuge、Ultra Low temperature refrigerator，paraffin
    slicing machine，paraffin embedding machine, cell centrifuge
    smearing machine, and full automatic dying machines. No clinical
    trial reports or type - test reports are required.

[^3]: *2004 China Medical Market Report* by The Golden Triangle
    Organization, Inc.