Medical device inspection includes pre-listing registration inspection，post-listing daily supervision and supervision sampling inspection，etc.，which plays an important role in ensuring the safety of the people’s equipment. By combing the history of the national medical device inspection institution，combining with the state key laboratory of medical device approved by the State Drug Administration，this paper gives a comprehensive introduction to the examination ability of the national medical device inspection system，including the history of the development of the national medical device inspection institution，the staffing of each inspection institution，the allocation of infrastructure，technical advantages and scientific research. As far as possible，the development status of medical device inspection institutions outside the drug supervision system is included，and the examination ability of medical device in China is described in details. In view of the rapid development of medical device technology and industry，look forward to the future development direction of inspection institutions，so as to provide reference for the national scientific and reasonable construction of medical device inspection system，and to help the existing inspection institutions to develop healthily in order to meet the development and needs of the industry.