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本文阐述了医疗器械风险管理的起源、发展及基本内涵，介绍了国内外医疗器械不良事件的监测现状及其工作内容，论述了医疗器械不良事件监测与风险管理的相互关系，并以典型案例论证了医疗器械风险管理的重要性。
<<This paper is to explain the origin，development and the basic content of risk management of medical devices；introduce the condition and scope of monitoring for medical device adverse events in China and foreign countries；discuss the mutual relations between the medical device adverse event monitoring and risk management；and demonstrate the importance of risk management of medical device with typical cases.
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