摘要
目的探讨医疗器械不良事件信息管理机制,为我国医疗器械上市后风险管理提供参考。方法通过分析国内现状,参考欧美管理模式,提出适合我国国情的医疗器械不良事件信息管理机制。结果提出了建立医疗器械不良事件原始报告信息共享机制和生产企业主体评价机制以及不同类型的风险信息公示及通报机制,并就建立这些机制应该采取的措施提出了意见。结论建立新的医疗器械信息管理机制能够更好地保障我国医疗器械上市后风险管理工作的运行,提高医疗器械上市后监管的效率。
Objective To probe into the mechanisms of medical device adverse event information management, so as to provide reference for medical device post-marketing risk management in China. Methods The mechanisms of medical device adverse event information management suitable for China were proposed by analyzing the domestic present status and referencing the mode in Europe and USA. Results The mechanisms of medical device adverse event initial report sharing, evaluating by manufacturer as main body and publicizing and notifying risk information by different types were proposed. The actions of establishing these mechanisms were also suggested. Conclusion Establishing new mechanism of medical device adverse event information management can ensure the better running of medical device post-marketing risk management in China and improve the efficiency of medical device post-marketing regulation.
出处
《中国药物警戒》
2016年第3期148-153,共6页
Chinese Journal of Pharmacovigilance
关键词
医疗器械
不良事件信息
风险
管理机制
medical device
adverse event information
risk
management mechanism
