China’s State Food and Drug Administration (SFDA) has decided to select medical device experts to enforce its “Regulations for Supervision and Administration of Medical Devices” and “Provisions for Medical Device Registration.” These experts will help standardize the technical examination of medical devices and ensure fair and efficient evaluation procedures. These experts will be available to the SFDA for medical device evaluation.
The SFDA issued draft revisions to these regulations in September 2007. Major changes included a new system on medical device recalls, increased checks during product registration, and standardizing manufacturing processes.