国内外医疗器械登记研究现状与分析

Current Status and Analysis of Overseas and Domestic Medical Device Registry Study

医疗器械登记作为一种真实世界的数据来源,越来越受到各个国家的重视,并逐渐被各国医疗器械监管部门所接受,为制定医疗器械监管决策提供支持。文章对国际医疗器械监管机构论坛(International Medical Device Regulators Forum,IMDRF)开展医疗器械登记研究情况和我国开展相关研究情况予以简要介绍和分析,并讨论我国现阶段开展医疗器械登记研究面临的机遇与挑战,以期对我国医疗器械登记的发展有所启示。

As a real-world data source,medical device registry has attracted more and more attention from various countries,and has gradually been accepted by medical device regulatory authorities in various countries,providing support for making medical device regulatory decisions.This paper gives a brief introduction and analysis of the research on medical device registry carried out by the International Medical Device Regulators Forum(IMDRF)and the related research carried out in China,and discusses the opportunities and challenges faced by the research on medical device registry at the present stage in China,with a view to inspiring the development of medical device registry in China.