国际医疗器械监管机构论坛患者登记项目指南介绍与启示

doi:10.19803/j.1672-8629.20220194

摘要/Abstract

摘要： 目的通过分析国内外患者登记研究实践和国际医疗器械监管机构论坛（IMDRF）患者登记项目指南文件,为我国开展医疗器械患者登记研究提供参考。方法通过介绍IMDRF指南文件了解建立医疗器械患者登记的技术原则,通过探究国内外实践了解医疗器械患者登记研究的建立基础、运营模式、研究问题、覆盖人群等。结果医疗器械患者登记研究是主动监测的一种,可以成为我国当前医疗器械不良事件监测评价工作的重要补充,使医疗器械相关各方获益。结论应积极推动建立患者登记研究合作,服务医疗器械上市后监测。

关键词: 医疗器械, 评价, 患者登记, 主动监测

Abstract: Objective To provide a reference for the implementation of medical device patient registry research in China by analyzing domestic and international practices and the technical guidelines of International Medical Device Regulators Forum(IMDRF). Methods The technical principles were understood by learning the guidelines of IMDRF, the foundation, operation, study questions and population coverage were known by studying the medical device patient registry practices of different countries. Results Medical device patient registry was an important positive surveillance method, and it could be an important supplement of medical device adverse event surveillance in our country, which would benefit different interested groups. Conclusion To assiste the post-market surveillance of medical device, the related cooperation of patient registry should be positively encouraged and established.

Key words: medical device, reevaluation, patient registry, positive surveillance

中图分类号:

R951

赵一飞, 赵燕, 董放, 郑立佳, 李栋, 宋雅娜. 国际医疗器械监管机构论坛患者登记项目指南介绍与启示[J]. 中国药物警戒, 2022, 19(10): 1091-1096.

ZHAO Yifei, ZHAO Yan, DONG Fang, ZHENG Lijia, LI Dong, SONG Yana. Introduction and inspiration of international medical device regulators forum patient registry guidelines[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1091-1096.

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