关键词: 医疗器械严重不良事件, 调查机制, 探讨

Abstract: Investigating serious adverse events of medical devices is the important process of evaluating the relevance between medical devices and adverse events, and is the key to provid the evaluation report about serious adverse events of medical devices for the supervision and management department. By reviewing the current situation of medical devices adverse events monitoring and reevaluating, improving the legislation has been proposed to identify the investigation duty of serious adverse events of medical devices, and the investigation mechanism of serious adverse events of medical devices has been discussed .

Key words: serious adverse events of medical devices, investigation mechanism, discussion