In December 2018, China's National Medical Products Administration (NMPA) released the Special Medical Device Special Review Procedure (No. 83 of 2018), as part of their efforts to encourage innovation in medical device research and development. This revision to the"Innovative Medical Device Special Review Procedures" will abolish the previous "Special Approval Procedure for Innovative Medical Devices (Trial)" (Food and Drug Administration  No. 13).
ARQon has summarised the submission document list for easy reference. Check out the following link for the document list: