浅析医用妇科凝胶产品的注册概况及审评要求

Analysis on the Registration Overview and Review Requirements of Medical Gynecological Gel Products YAN Fang CHAI Qian

通过对国家药品监督管理局的境内医疗器械注册产品数据库(截至2023年9月初)进行检索,对目前已注册的456个医用妇科凝胶产品的注册概况进行介绍,梳理产品存在的问题,然后结合审评要求对产品的管理属性和管理类别、产品名称、结构组成、适用范围、产品技术要求、临床评价等内容进行分析探讨,以期为注册申请人以及技术审评人员提供思路,同时也为产品上市后的监管提供参考。

By searching the database of domestic medical devices(as of early September,2023)of the National Medical Products Administration,this article introduces the general situation of 456 Medical Gynecological Gel products that have been registered so far,sorts out the existing problems in the product,then analyzes and discusses the manage attributes and categories,product name,structural composition,scope of application,product technical requirement,clinical evaluation combined with review requirements,in order to provide reference for applicants and technical reviewers,at the same time,it also provides reference for post market supervision of product.