Technical Review Guideline of Medical Device Software

On June 5, 2020, CMDE start to collect comments on the Technical Review Guideline of Medical Device Software (Draft Edition 2). This guideline may have an impact on the registration of the self-developed software, off-the-shelf software, and Class II or Class III SaMD (software as a medical device) and SiMD (software in a medical device). If you are related to any of the products above, your comments or opinions about this guideline can be submitted by July 3, 2020, via email.

Link:https://www.cmde.org.cn/CL0004/21039.html