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Health
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Medical
Device Regulatory
Requirements for
China
Pepared
by: Jay Biggs
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Agency |
Website |
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State Food and Drug Administration |
http://www.sfda.gov.cn/eng/ |
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General Administration of Quality Supervision, Inspection and Quarantine - Certification and Accreditation Administration |
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Ministry
of Health |
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.
According to Article 2 of the Directive to Medical Device Administration (LINK TO CHINACLASSIFICATION.PFD), 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.
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.
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.
SFDA
has a document (Regulation for Medical Device Classification),
which provides general guidance on how to determine which classification
a device falls under. (LINK TO CHINA CLASSIFICATION 2 DOCUMENT)
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.
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.
The
form used to apply for device registration can be found on the China
Medical Device Information Network website (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 |
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Application
for the Registration of Medical Devices |
http://www.cmdi.gov.cn:5555/sbl/bszn/setup.exe
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To register medical with the State Food and Drug Administration |
|
CCC Application Online Guide |
To apply for CCC Mark |
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.
The following items are to be submitted with all applications:
§
other necessary
contents specified in the Product Standards.
The SFDA has 90 working days to complete its regulatory review of each product. This three-month period however, is not binding as some questions will be asked and additional materials required. U.S. companies report that the product registration time has increased from 4-6 months, up to a year. License renewal applications (which must be done every 4 years) can also take between 4 – 6 months, as they are often treated the same as new product. In addition to the 90 day review period, SFDA has a requirement that laboratories complete all testing within one month. In theory, if a lab can not do the required testing within a month, SFDA will accept test reports conducted in the product's country of origin. In practice, this often takes 60 – 90 working days. This lab testing time period is not included in the SFDA 90 day review period.
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 perishible
products, language or marks noting "perishible 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.
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 Proceedures - 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 centralised
urchasing 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 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 Supervision and Administration of Medical Devices |
http://www.sfda.gov.cn/en |
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CCC Mark Requirements |
Appendix 1: SFDA Accredited Laboratories for Medical Device
Testing
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
[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.
Appendix 2: For more information, read the following 2005 Commercial Service Market Reports.
China's Health Care Construction Market
Last updated on 12-20-05 by JF