In 2018，NMPA Comprehensively deepen medical device evaluation and approval reformation，according to the “Opinions on Deepening of medical device review and approval reform，encourage the innovation and development of Drug and Medical Device industry”，issued by General Office of the CPC Central Committee and General Office of the State Council，adopting international advanced experience，building the foundation of requirements for medical device supervision，setting scientific application requirements，standardizing procedures，focus on the clinical evaluation and supporting of innovation medical device，stimulating industry vitality，meet people’s demand for using advanced medical device and safty.