欧盟医疗器械警戒制度浅析与思考  

Medical Device Vigilance Systems in European Union

作　　者：赵燕 赵一飞 郑立佳 董放 ZHAO Yan;ZHAO Yifei;ZHENG Lijia;DONG Fang(Center For Drug Reevaluation,NMPA,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国药物警戒》2021年第6期566-569,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2021YFC2009100)。

摘　　要：目的通过分析欧盟医疗器械法规修订案中关于医疗器械警戒系统所涉及的各方职责和相关要求,为建立我国医疗器械警戒工作制度提供参考。方法通过查阅相关文献,了解欧盟医疗器械警戒工作制度的现状与优势,对比分析我国医疗器械不良事件监测工作现状。结果医疗器械警戒制度是开展医疗器械全生命周期风险管理、确保公众用械安全的核心举措。结论借鉴欧盟经验,结合我国医疗器械不良事件监测工作实践,提出我国开展医疗器械警戒工作的思考和建议。Objective To provide reference for the establishment of medical device vigilance systems in China by analyzing the responsibilities and requirements of the medical vigilance system in the amendments to European Union(EU)medical device regulations.Methods The advantages of the EU medical device vigilance system were analyzed and compared with the monitoring of medical device adverse events in China.Results The medical device vigilance system was critical to risk management of the whole life cycle of medical devices and to the safety of the public.Conclusion Ways to improve medical device vigilance in China are suggested by learning from the experience of European Union and based on the current monitoring practices of medical device adverse events in China.

关 键 词：欧盟 医疗器械 警戒系统 2017/745号医疗器械法规 风险管控 

分 类 号：R951[医药卫生—药学]