摘要
本文旨在深入探讨美国和欧盟的医疗器械上市后监管制度,包括风险监管理念、监管法规体系、上市后临床研究、质量管理体系等,总结出开发风险监测工具、落实风险管理、采用合并报告模式、公开风险信息等经验,为我国医疗器械行业有序发展提供参考。我国可以借鉴美欧医疗器械上市后的监管实践,从提高监管机构能力、建设监测哨点和强化法规框架等方面,建立和试点医疗器械警戒制度。
This paper aims to explore the post-market regulatory systems for medical devices in the United States and the European Union,including risk regulatory concepts,regulatory legal systems,post-market clinical studies,quality management systems.It summarizes the experiences of developing risk monitoring tools,implementing risk management,merging reporting models,disclosing risk information.The aim is to provide insights and references for the systematic development of China's medical device industry.China can learn from the post-market regulatory practices of medical devices in the United States and the European Union to establish and pilot a robust medical device vigilance system,improving regulatory agency capabilities,building monitoring outposts,and strengthening the legal framework.
作者
李尧
卞蓉蓉
焦灵利
李明
宋雅娜
郑立佳
李栋
赵一飞
赵燕
LI Yao;BIAN Rong-rong;JIAO Ling-li;LI Ming;SONG Ya-na;ZHENG Li-jia;LI Dong;ZHAO Yi-fei;ZHAO Yan(Center for ADR Monitoring of Jiangsu;Center for Drug Reevaluation,NMPA;NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance)
出处
《中国食品药品监管》
2024年第2期94-103,共10页
China Food & Drug Administration Magazine
基金
国家重点研发计划(2021YFC2009100、2021YFC2009104)
中国药品监管科学行动计划第二批重点项目([2021]37-10)。
关键词
医疗器械
警戒制度
不良事件监测
风险
试点
medical devices
vigilance system
adverse event monitoring
risk
pilot
