The reform of China medical device evaluation system has comprehensively deepened in 2017. According to the overall deployment and requirement of the reform，the Center for Medical Device Evaluation of CFDA earnestly implement the requirement of Notice on deepening the evaluation and approval system reform to encourage innovative drugs and medical devices，to accomplish the mission of guarantee the safety and efficacy of medical device. The reform has been systematically planned and implemented straightly to optimize the procedure of evaluation and approval，standardize the management of evaluation，reinforce the personnel resource management system，strengthen the information construction，as well as improve the evaluation quality and efficiency.