The Enlightenment of the Management of EU Notified Bodies to China's Introduction of Third-Party Institutions for Medical Device Supervision

Abstract

Objective: By introducing the pilot situation of post-market supervision of medical devices purchased by third-party institutions in Jiangsu Province, China, the problems exposed by them were analyzed. At the same time, it draws on relevant advanced experience in the management of EU notified bodies to provide suggestions for optimizing China's follow-up practices and promoting social co-governance supervision.
 Method: Conduct on-the-spot investigations in Jiangsu Provincial Food and Drug Administration, China, conduct interviews with regulators on the progress of the project, and conduct in-depth communication. A large number of inquiries about the relevant research literature of the EU notified body and the laws and regulations promulgated by the EU, and systematic analysis.
 Results: In the introduction of third-party agencies to assist post-market supervision of medical devices, the Chinese government still has problems such as lack of relevant laws and regulations, imperfect access mechanisms for third-party agencies, imperfect supervision mechanisms, and backward regulatory informatization construction.
 Conclusion: Introducing third-party agencies to assist in the supervision of medical devices can effectively ease the pressure on supervision and supplement supervision resources. It is suggested that the Chinese government learn from the management experience of the EU notified bodies, improve the regulatory legal system, introduce relevant regulations, improve the access mechanism of third-party institutions, improve the supervision mechanism, strengthen the construction of supervision informatization, and build a unified supervision platform.