China’s Center for Medical Device Evaluation (CMDE) published several new pieces of guidance that medical device manufacturers doing business in the country should review to confirm continued compliance. All links below are in Chinese.
Updated compliance guidelines from CMDE for medical device safety and performance
The CMDE published new guidance to help medical device registration applicants interpret how to implement Essential Principles of Medical Device Safety and Performance, issued in March 2020. CMDE Announcement No. 29 of 2022, Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance, was created to help medical device manufacturers integrate the requirements of the regulation into the development and manufacture of medical devices. Notably, the guidelines identify applicable products and methods to demonstrate compliance for each section of the Essential Principles…
