世界各国医疗器械不良事件监测现状比较  

Current Situation Comparison of Medical Device Adverse Event Monitoring Among the Developed Countries

作　　者：张素敏[1] 曹立亚[1] 曾光[2] 

机构地区：[1]国家药品不良反应监测中心,北京100061 [2]中国疾病预防控制中心,北京100050

出　　处：《中国医疗器械信息》2005年第6期52-56,共5页China Medical Device Information

摘　　要：医疗器械不良事件监测是确保上市医疗器械安全有效的重要手段之一。世界各国在医疗器械不良事件监测的法规和技术指南方面不尽相同,本文就各国有关的法规和技术指南当中对医疗器械不良事件监测的概念、报告程序、报告范围和时限等要求方面的异同进行了比较,并对可能的原因进行了分析。Medical device adverse event monitoring is one of the most important methods to guarantee the safety of post-marketing products, There will be some difference on regulations and guidelines in different countries. Current situation comparison of medical device adverse event monitoring among the developed countries has been done in this article.

关 键 词：医疗器械不良事件 监测现状 世界 医疗器械安全 技术指南 报告程序 法规 

分 类 号：R197[医药卫生—卫生事业管理] R47[医药卫生—公共卫生与预防医学]