China Food and Drug Administration (CFDA) proposed major changes to medical device regulatory requirements by amending Order No. 650. The timeframe for the implementation of such changes has not been announced by CFDA yet, but foreign medical manufacturers are welcoming the new changes as they will address the major issues they are facing while registering their medical devices in China.
As summarized here below, the changes address issues related to the requirements of local testing of products, approval in country of origin, clinical evaluation reports (CER) and Unique Device Identification (UDI):
- Product test reporting: Registrants may submit either self-test reports or test reports obtained from qualified organizations.
- Imported innovative devices:Innovative medical devices imported into China would not require approval in country of origin before being registered in China.
- CER requirements: Class II medical devices would not be required in principle to provide CERs in their CFDA premarket applications.
- Implementation of UDI: An UDI system will be implemented for the Chinese medical device market in the near future.
- Importation of used devices: The importation and distribution of used medical devices will be forbidden in China.
- Legal manufacturer definition: The official definition of medical device legal manufacturer would be changed to that of marketing authorization holder.
- Penalties: More penalties will be applied to illegal acts including permanent prohibition from the Chinese market and jail time.