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.
出处
《中国药物警戒》
2009年第6期369-372,共4页
Chinese Journal of Pharmacovigilance
关键词
医疗器械
警戒系统
指南
启示
medical device
vigilance system
guidance
enlightenment system in the strengthening guidefine on
