我国医疗器械不良事件监测管理中的问题和对策

Current problems and suggestion on medical device adverse event management in China

通过对我国医疗器械不良事件管理的法规和管理实践进行历史回顾与现状分析,找出目前我国医疗器械不良事件监测和管理存在的问题,并提出对策,保证医疗器械使用的安全有效。

Based on historical review and situation analysis of Chinese medical device adverse event management, here it points out the current problems and countermeasures of medical device adverse event management in China.It is to assure of medical device’s safety and effectiveness.