“Regulation of Medical Device Clinical Trial Quality Management (so called China GCP)” issued on March 1, 2016 specifies that “Clinical trial sites must be on the NMPA filed institutions for Medical Device Clinical Trial Sites”. The new policy became mandatory on January 1, 2019. more…
You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory documents from NMPA are only available in Chinese (you can contact us for English copies). First of all, to begin to understand the NMPA’s process, you need to know about these 4 things that matter to medical device classification and registration in China. more…
