Abstract: Objective To explore the role and significance of national arthroplasty registries in the post-market active surveillance of medical devices in order to provide a reference for establishing such a system in China. Methods By reviewing related literature, the developments, characteristics, and cases of applications of national arthroplasty registries worldwide were analyzed. Based on the need for regulation of medical devices in China, the applicability of these registries in surveillance of implant safety was evaluated. Results and Conclusion As an effective tool for post-market active surveillance of medical devices, national arthroplasty registries have been successfully implemented in many countries, which can facilitate early identification and control of implant-related risks. It is recommended that China quicken the establishment of a national arthroplasty registry, improve the system for regulation of whole lifecycle of medical devices and enhance the ability to monitor the safety of implants.

Key words: Implant, Arthroplasty, Medical Device, Registry, System, Post-Market Surveillance, Real-World Data