Currently, China’s medical device market is worth approximately $3.5 billion. Moreover, the number of foreign companies registering medical devices in China nearly doubled between 2003 and 2004. The State Food and Drug Administration (SFDA), which regulates medical devices in China, has been taking measures to create a better medical device regulatory environment.
On March 22, 2005, the SFDA announced new changes to its medical device registration requirements. Under the new requirements, a total of 12 documents must be submitted to the SFDA in both Chinese and English. The required documents are summarized as follows.
- SFDA registration form
- Legal Production Qualification (e.g., US 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 US-made devices issued by FDA or Free Sale Certificate)
- Product Standards (ISO, CE, AAMI, etc.); include an authorization letter to a Chinese agent to translate and reformat the product standard according to Chinese regulation
- 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)
- Authorization letter to a Chinese agent, responsible for reporting adverse events accrued in China (includes an authorization letter from the manufacturer, and a promise letter from the Chinese agent, the agentâ€™s qualification document)
- 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)
Previously, all documents executed in the US had to first be authenticated by a Chinese Embassy or consulate before they were eligible for use in China. As of March 22, 2005, authentication by the Chinese Embassy or consulate is no longer required. Additionally, copies of government certificates, i.e. Number (4) above, will be accepted by the SFDA, but should be notarized.