Tag Archive for: clinical evaluation report

China Releases Draft Clinical Evaluation Exemption List for 2022

On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.

China NMPA Adds 47 Products to Clinical Trial Exemption List

China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.

China Issues Recommendation for Medical Device Clinical Data

For medical device registration in China, one of the most important documents to be provided is  clinical data.