美国医疗器械上市后监测体系运行经验及启示

United States Medical Device Postmarket Surveillance System Operational Experience and Learning

为了了解美国医疗器械上市后监管体系的发展历程、架构及最新监测研究办法,寻求对我国具有借鉴意义的工作方法,反馈至医疗器械生产环节;该文梳理了近年美国食品药品监督管理局(FDA)出台的医疗器械上市后监测指导性文件,分析现阶段上市后监测的实施状况。FDA医疗器械上市后监测的各环节联动、多数据来源和部门之间协调沟通机制值得我国学习借鉴。

To learn the progress, structure and the latest development of medical device postmarket surveillance system in United States, endeavor to get a meaningful approach for Chinese medical device manufacturers. Sort out the recentyear guidance documents issued by US FDA, analyze the current situation after the implementation of postmarket surveillance system （PMS）. The all-aspect linkage, multiple data sources and the coordination communication mechanism between various departments implemented by FDA are worthy of learning.