IMDRF协调性指南文件《监管机构对医疗器械合格评定机构认可要求》内容简介及思考

Introduction and Consideration on the IMDRF Guidance Document“Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews”

国际医疗器械监管机构论坛2020年发布的《监管机构对医疗器械合格评定机构认可要求》协调性指南文件,载列了执行医疗器械监管审查工作的合格评定机构应符合的要求,旨在鼓励和支持监管体系的国际融合。文章简要介绍该文件主要内容,思考并总结文件所汇集的国际经验和共识,为我国医疗器械监管审查能力进一步提升提供参考。

In 2020,the International Medical Device Regulators Forum(IMDRF)released the harmonized guidance document“Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews”.It sets out the requirements that medical device conformity assessment bodies conducting Medical Device regulatory reviews should meet,aimed at encouraging and supporting global convergence of regulatory systems.This article briefly introduces the main content of the document,summarizes the international experience and consensus gathered in the document,and provides a reference for the further improvement of China’s medical device regulatory review capability.