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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:
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:
Authentication: 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:
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. Authentication Fees: The following is a breakdown of the fees that the Chinese Embassy and Consulate General’s office charge for authenticating documents:
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. General Information 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:
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
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