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.

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.

Ministry of Health & 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.

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

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.

Registration Procedures

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 ?C 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.

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.

What Information is Asked for During the Registration Process?

The following items are to be submitted with all applications:

• Business license o 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.

o 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
o 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
o 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.
o Product introduction: component, applications, materials, volume of product, sterilization method;
o Characteristics of the product: sterile, non thermogenic, etc.; disposable, self destroying model, reducing cross infection; factory standards

• Operation manual of the product
o 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).
o Note that some high tech medical devices are eligible for registration before the results of testing are complete (Test-after-Registration) .
o Certain laboratory equipment is also exempt from type ?C testing requirements .
o For more information about these exemptions, along with a more in depth discussion of the registration requirements above, go to here

• 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 ?C12 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

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 ?C 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.

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

1. 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.
2. 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.
3. 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 ?C 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

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:

• Application. - Submission of an application and supporting materials, including user guides, CB reports, EMC reports, regulatory labels and other information.
• Type Testing - A CNCA-designated test laboratory in China will test product samples.
• 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.
• Evaluation - evaluation of certification results, and approval (or failure or retesting).
• Follow-up Factory Inspection - Manufacturing facilities for the product will be re-inspected by Chinese officials every 12-18 months.