Nmpa is a certification of the National Food and Drug Administration.
Nmpa was originally the CFDA, and on September 1, 2018, it was changed to the National Food and Drug Administration (NMPA), which is responsible not only for medical devices, but also for pharmaceuticals, biologics, food and cosmetics.
Thus, the NMPA took over the CFDA, especially in ensuring public health safety through safe and effective devices and products. Like the CFDA, the NMPA is the only agency responsible for the approval and registration of imported medical devices.
What mmpa can certify:
1. Initial registration/approval of medical devices (including IVD devices).
2. Changes to existing registrations of domestic Class III medical devices and foreign Class II and III medical devices.
3. Application for clinical research of foreign Class III medical devices.
4. Changes in the instructions for use of medical devices.
5. Extension of medical device license.
6. Application for approval of innovative medical devices.
7. Changes, corrections and cancellation of medical device license.
8. Application for "type testing", i.e., testing of the device in an accredited testing laboratory as required by China.