The year 2019 is the final year of the implementation of the reform of the medical device examination and approval system in China. This paper reviews the progress made in the reform of medical device evaluation and approval system in 2019，including improving the quality efficiency through re-engineering review process，strengthening quality management，standardizing the management of expert consultation，promoting the evaluation of products with high priority of innovation，promoting the evaluation of major projects，guiding and supporting the declaration of innovative products，encouraging the innovation of medical devices，actively promoting scientific review，promoting the implementation of electronic application for registration，and enhancing the five professional levels of evaluation teams. In order to further promote the reform of the examination and approval system，it is suggested that，firstly，we should continue to push forward the reform，carry out the analysis and evaluation of the examination and evaluation system，actively cooperate with the revision of the regulation and document system，actively promote the intellectual review and evaluation，and，secondly，improve the level of the examination and evaluation and scientific management system. Thirdly，realize the scientific management system of effective operation evaluation. Fourth，promote the construction of the evaluation teams.