In recent years,real-world study(RWS)has played an increasingly important role in promoting the innovative development of medical devices and supporting post-market safety regulation of medical devices.This article reviews the application of RWS in both international and domestic contexts for post-market safety evaluation and policy-making of medical devices.Besides,it combines with the application of RWS to support post-market safety evaluation of medical devices in the Hainan Free Trade Port.In response to the opportunities and challenges faced in applying RWS for post-market safety evaluation,this article proposes thoughts for using real-world data to enhance the post-market safety evaluation of medical devices in China.
维普
万方数据