Introduction Of Medical Device Registration Process In China


This shortvideo is the introduction of medical device registration process in China. First, we need be clear that what kind of medical devices need pre market approval in China. The medical devices classified as Class II & III need to apply for registration in China. And those devices belong to Class I just need filing. The main process includes acceptance of dossiers submission, payment to NMPA for service fee, technical review conducted by NMPA reviewers, approval and certificate issuance.