浅谈二类医疗器械独立软件的申报注册

Discussion about the Registration of Independent Software for Class Ⅱ Medical Device

自CFDA发布《医疗器械软件注册技术审查指导原则》后,软件成为医疗器械注册审评中关注的重点和热点,本文将重点探讨如何做好二类医疗器械独立软件注册申报工作。

Since CFDA public released the guidance of registration technology for medical device software , the software has become the focus and hot spot in the medical device registration. This article will focus on how to do independent software of class II medical device registration declaration.