Abstract: Objective To provide a reference for the implementation of medical device patient registry research in China by analyzing domestic and international practices and the technical guidelines of International Medical Device Regulators Forum(IMDRF). Methods The technical principles were understood by learning the guidelines of IMDRF, the foundation, operation, study questions and population coverage were known by studying the medical device patient registry practices of different countries. Results Medical device patient registry was an important positive surveillance method, and it could be an important supplement of medical device adverse event surveillance in our country, which would benefit different interested groups. Conclusion To assiste the post-market surveillance of medical device, the related cooperation of patient registry should be positively encouraged and established.

Key words: medical device, reevaluation, patient registry, positive surveillance