《欧盟医疗器械警戒系统在英国的实施指南》简介及对我国的启示  

A Brief Introduction of the Guidance on the Operation of the EU Vigilance System in the UK and Suggestions for Our System

作　　者：白洁[1] 彭诗荣[1] 杨悦[1] 

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国药物警戒》2009年第6期369-372,共4页Chinese Journal of Pharmacovigilance

摘　　要：通过对2008年9月颁布的《欧盟医疗器械警戒系统在英国的实施指南》的研究,简要介绍其主要内容,并提出我国应该加强企业责任主体建设,完善上报内容,制定医疗器械不良事件监测指南等建议。On the basis of study on the Guidance on the operation of the EU vigilance UK, this guidance has been introduced. Some suggestions have been proposed, such as the responsibility of the manufacturer, perfecting submission contents, developing the medical device adverse event monitoring and so on.

关 键 词：医疗器械 警戒系统 指南 启示 

分 类 号：R197.39[医药卫生—卫生事业管理] R95[医药卫生—公共卫生与预防医学]