上海市第二类无源医疗器械技术审评发补常见问题分析

Analysis of Common Problems in the Technical Review and Supplement of Shanghai’s Class Ⅱ Passive Medical Devices

文章汇总自2021年1月~12月上海市医疗器械化妆品审评核查中心的332件第二类无源医疗器械的注册申请件,梳理了技术审评发补中的常见问题,并进行分类描述与分析,以期为医疗器械注册申请人准备注册申报资料及技术审评人员进行技术审评提供参考。

The article summarizes 332 applications for the registration of Class Ⅱ passive medical devices from January to December 2021 at the Shanghai Medical Devices and Cosmetics Review and Verification Center. It also sets out and analyzes common problems in the technical review process by category for the reference of medical device registration applicants who are preparing registration declarations and for technical reviewers who are conducting technical reviews.