关键词: font-size:medium, "> , 医疗器械； 注册； 风险管理

Abstract: Risk management is an activity throughout the whole life cycle of medical devices，which plays an important role for assuring the safety of medical devices. By comparing the requirements for medical device risk management in China and European Union， this article finds the differences between them and provides reference for technical review.

Key words: font-size:medium, ">Medical device； Registration； Risk management