Approval of domestic class III and imported medical devices

On November 2, the National medical product administration-NMPA issued the operation specifications for the registration and approval of domestic class III and imported medical devices. NMPA is responsible for the administrative examination and approval of the registration of domestic category III and imported category II and III medical devices. The registration and approval of domestic class III and imported class II and class III medical devices (including in vitro diagnostic reagents) (referring to product registration, change registration and continuous registration) includes four links: acceptance, technical review, administrative approval and approval preparation. The approval of clinical trials includes three links: acceptance,Read More →