我国医疗器械不良事件监测现状研究

Study on the Current Situation of Medical Device Adverse Events Monitoring in China

医疗器械不良事件监测是医疗器械上市后风险管理的重要手段之一。通过对我国医疗器械不良事件监测工作现状的研究,分析现阶段监测工作中存在的问题,力求为更好地开展此项工作提供思路。

Medical Device Adverse Events （MDAE） monitoring is one of the important methods for the risk management of the post-market medical devices. By analyzing the current situation and problems of MDAE monitoring in China, provide some useful references for MDAE monitoring system.