浅析美国医疗器械上市后风险管理模式及对我国的启示

我国正处于药械安全风险高危时期,需要尽快健全我国药械上市后风险管理体系,保障人民群众的用药用械安全。因此,借鉴发达国家医疗器械监管的先进经验,有利于我国医疗器械上市后风险管理体系的建立与完善。通过阐述美国食品药品监督管理局医疗器械上市后风险管理模式的结构、功能以及遇到的挑战和对策,从中提炼我国在医疗器械上市后风险管理中值得借鉴的经验。

Analysis and Apocalypse of FDA Risk Management of Post-Market Medical Device

With the drug and medical device safety involving a high degree of risk in our country,the risk management system of post-market drug and medical device need to be developed as soon as possibly to ensure people's health. Therefore,learning the advanced supervision experience from the developed countries is favourable to establishing and perfecting the risk management system of post-market medical device in our country. The framework,functions and problems of FDA risk man-agement system of post-market medical device are illuminated to conclude the beneficial experi-ence to our country.