中国与欧盟医疗器械风险管理要求对比及分析

Comparison and Analysis of Medical Device Risk Management Requirements Between China and EU

风险管理是贯穿于医疗器械全生命周期的活动,对保证医疗器械的安全具有重要的作用。本文通过对比中国和欧盟医疗器械注册申报资料中风险管理的要求,发现两者的异同点,为医疗器械技术审评工作提供参考。

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.