Consideration and Practice of Introducing Third-party Certification Institutions to Participate in Post-marketing Supervision of Medical Devices

Abstract

After years of international regulatory practice, the third party certification bodies have become an important social force in the field of medical devices supervision. It is broadly discussed how to introduce social resources to play an active role in the supervision of medical devices under the regulatory system of medical devices in China. Shanghai Medical Products Administration has carried out research and preliminary practice on the participation of third-party institutions in post-marketing supervision of medical devices. The article mainly focuses on purpose, entry point, inspection criteria and result disposal of introducing the participation of third-party institutions in the post-marketing supervision, meanwhile, discusses the next work direction at the same time.