The registration inspection is a compulsory inspection procedure for Class II and Class III medical device products before registration and marketing. The development of China's medical device inspection service market is relatively backward, and the development of third-party inspection agencies is slow. At present, the registration and the inspection of medical devices are mainly completed by official medical device inspection institutions, with the responsibilities of the government and the enterprises being mingled, and the industry inspection demand is difficult to meet. For clarifying the relationship between the regulatory authorities and the industry enterprises, it is suggested that the current medical device registration and inspection system should be reformed by using the self inspection, the entrusted inspection and the role transformation of inspection institutions.

medical device  /  registration inspection  /  testing institutes  /  entrusted inspection