The Chinese medical device market is currently worth about $2.5 billion and it is growing rapidly. Exporting to China is becoming easier and tariffs on most medical devices have been reduced to 3.9% as of January 1, 2005. The U.S. is the leading exporter of medical devices to China, with U.S. products making up 1/3 of all imports.
Despite relaxed restrictions, there remain many difficulties in exporting medical devices to China. Local procurement policies, test requirements, protection of intellectual property, restrictions on the types of business activities foreign firms can engage in and complex product registration processes all present potential hurdles to medical device exporters.
Medical Device Regulatory Agencies in China
The State Food and Drug Administration (SFDA) is the Chinese equivalent of the U.S. FDA. All imported medical devices must obtain registration certification from the SFDA.
The General Administration of Quality, Supervision, Inspection and Quarantine (ASQIQ) is another Chinese agency that regulates imported medical devices. AQSIQ conducts mandatory safety registration, certification and inspection for certain devices.
Medical Device Classification
As in the U.S., medical devices are split into three categories, each with specific regulatory requirements. The classifications are as follows:
- Class I: Low risk devices, regulated by provincial governments.
- Class II: Modest risk devices, regulated by provincial governments.
- Class III: High risk devices, regulated by the SFDA.
Required Documents and Authentication Procedures for Medical Device Registration
In order to register a medical device, a total of 11 documents must be collected and submitted to the SFDA in both Chinese and English. The required documents are summarized here:
- SFDA registration form
- Legal Production Qualification (e.g., U.S. FDA registration)
- Business license for the Chinese agent registering the product (The agent must be located in China, have a valid license, and have a letter of commission from the manufacturer)
- Marketing approval from government of country of origin (Certificate to Foreign Government as well as 510(k), pre-market approval (PMA) application for U.S.-made devices issued by FDA or Free Sale Certificate)
- Product Standards (ISO, CE, AAMI, etc.)
- Operation Manual (Product instructions)
- Test report issued by SFDA-certified test center (only required for Class II and III products that have not received ISO9000 certification)
- Clinical trial report (only required for certain types of devices; manufacturer may submit clinical trial data that was submitted in the country of origin)
- Quality guarantee letter (certifying that the product being registered and sold in China is identical to the product approved in the country of origin)
- After-sales authorization (this includes an authorization letter from the manufacturer, a promise letter from the after-sales agent, and an after-sales agent qualification document)
- Self-guarantee declaration (to vouch for truthfulness of submitted documents)
All documents executed in the U.S. to be used in China must first be authenticated. The Chinese Embassy and Chinese consulates provide this service. Before applying for authentication, the documents must first be:
- Signed before a notary public
- Certified by the clerk of the Court of the County where document is commissioned (if applicable)
- Certified by the Secretary of the State where the documents are executed
- Certified by the relevant Consulate-General (for applicants in the consular jurisdiction of the Embassy, documents must be certified by the U.S. Department of State Authentication Office, then by the Embassy)
After all of the preceding certifications are obtained, applicants must apply to the location with jurisdiction over the applicant’s place of business and submit to them an application for authentication. This application must be submitted through mail, or in person, to the Chinese Embassy or a Consulate, along with all certified documents needing authentication.
The following is a breakdown of the fees that the Chinese Embassy and Consulate General’s office charge for authenticating documents:
- $40 per document
- $5 for mail service
- $30 for 1 day processing (regular processing time is 4 days)
- $20 for 2-3 day processing
- Must be paid by money order, cashier’s check, company check or cash (no personal checks)
Product Registration Procedures
On August 9, 2004 the SFDA issued new regulations for the registration of medical devices in China. These new regulations have simplified the application and dossier review process for medical devices. Additionally, the Medical Device Clinical Trial Regulation, effective April, 2004, has laid out detailed requirements for clinical protocol, clinical hospitals and clinical reports in China.
Previously, a company prepared a dossier (with all required documents) and then applied to the SFDA for a specification validation (for approval of the specifications of the device to be imported). Once the specification validation was reviewed and approved, the company was then required to send samples to a testing center. A company would then file its dossier, with the approved specifications and the official testing report, to the SFDA. The SFDA would review the technical documents and judge whether to issue an import license.
The new regulations have combined the dossier preparation and specification application into one step. Companies no longer need to apply to the SFDA for specification validation. Instead, they may use their own specifications as a basis for a testing agency to provide testing. The company then includes these test results in its completed dossier and submits it to the SFDA. The SFDA then sends this dossier to the Medical Device Evaluation Center (MDEC) to review the specifications, dossier, government certificate and clinical report. The MDEC sends their conclusion to the SFDA and then, if everything is acceptable, the SFDA will issue the import license. While these new regulations have somewhat streamlined the process, they have not significantly altered the timeframe for medical device registration in China.
However, there are now several situations that can lengthen the new registration process. First, if the MDEC requires a supplement dossier, companies must complete the supplement and re-submit it to the SFDA within 60 working days. Second, since the specification validation is not required before testing, the testing is completed based on the company’s specifications. It is possible that the MDEC may request the company to revise its specifications and re-test, adding additional time and money to the registration process.
Product registration is valid for 4 years. In order to change manufacturing locations or add a new manufacturing location, a new product registration must be submitted. To change basic information, such as the manufacturer’s name, product name, or name of the manufacturing location, etc., an amendment to the product registration can be submitted.
Requests for renewal of product registration must be made 6 months before the initial registration expires. The renewal process is similar to the initial registration. Along with renewal forms, a copy of the original registration must be submitted. Product quality follow-up reports must also be submitted.
China Compulsory Certificate (CCC Mark)
The China Quality Certification Center requires that certain categories of medical devices obtain a CCC mark to ensure their safety. The CCC mark applies to the following categories of medical devices:
- Medical Diagnostic X-Ray Equipment
- Haemodialysis Equipment
- Hollow Fiber Dialysers
- Extra-corporeal Blood Circuit for Blood Purification Equipment
- Implantable Cardiac Pacemakers
- Artificial Heart-Lung Machine
Manufacturers can apply for the CCC mark directly to an Authorized Certification Body (ACB) or through a Chinese agent. Products requiring the CCC mark that are not properly marked may be held at the border by Chinese Customs and may be subject to other penalties.
Other Recent Regulations Affecting the Medical Device Market
- On July 8, 2004, the SFDA issued new regulations regarding inserts, labeling, and packaging. This is the first regulation of this sort to exist in China. The new regulation contains detailed requirements for what information companies must include on a product’s insert, label and packaging. All medical devices being exported to China must include this information in Chinese. The inserts must be reviewed and approved by the SFDA during registration. After approval, the content of the insert cannot be changed. If any changes must be made, the insert must be submitted to the SFDA for approval.
- On July 29, 2004, the SFDA released a second draft of a new diagnostic device registration regulation. The regulation only concerns diagnostic products in medical device categories (not those in the drug category). Registration requirements for diagnostic devices are now similar to those for medical devices. The regulation requires that 3 batches of the diagnostic device being registered be submitted for testing. The draft does not mention whether or not clinical trials will be required.