Legal analysis: the validity of the medical device business record certificate is five years, generally including the first class, the second class, the third class. Open the first class of medical equipment business enterprises, should be to the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for the record; open the second class, the third class of medical equipment business enterprises, should be by the provincial, autonomous regions and municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued the "medical equipment business enterprise license". No "medical equipment business license", the administrative department for industry and commerce shall not be issued a business license.
Legal basis: "Chinese people's *** and the basic medical care and health promotion law" Article 65 The state to strengthen the management of medical devices, improve the standards and norms of medical devices, and improve the safety and effectiveness of medical devices. The competent health department of the State Council and the competent health department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the advanced nature, appropriateness and accessibility of the technology, prepare large-scale medical equipment allocation planning, and promote the rational allocation and full **** enjoyment of medical equipment in the region.