Common Problems and Improvement Suggestions for the Special Review Application of Shanghai’s Class Ⅱ Innovative Medical Device

This study conducted statistics on the special review applications for Class Ⅱ innovative medical devices in Shanghai from April 2020 to April 2023. It summarized and analyzed common problems in the innovation review application stage, and gave suggestions for applicants and reviewers in order to further improve the quality of innovation application and improve the pass rate of innovation applications.