关键词: 医疗器械, 不良事件信息, 风险, 管理机制

Abstract: Objective To probe into the mechanisms of medical device adverse event information management, so as to provide reference for medical device post-marketing risk management in China. Methods The mechanisms of medical device adverse event information management suitable for China were proposed by analyzing the domestic present status and referencing the mode in Europe and USA. Results The mechanisms of medical device adverse event initial report sharing, evaluating by manufacturer as main body and publicizing and notifying risk information by different types were proposed. The actions of establishing these mechanisms were also suggested. Conclusion Establishing new mechanism of medical device adverse event information management can ensure the better running of medical device post-marketing risk management in China and improve the efficiency of medical device post-marketing regulation.

Key words: medical device, adverse event information, risk, management mechanism