Legal analysis: for the second class of medical devices for the record materials need: 1, business license and copy; 2, legal representative, enterprise responsible person, quality person in charge of identification, education or title certificate; 3, list of professional and technical personnel and professional and technical personnel of the identity card, proof of education, title certificate; 4, the organization and departmental setup description; scope of business, the business mode of description; 5, business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or by the housing lease issued by the housing lease certificate copy. Is warehousing commissioned by the third-party logistics of medical devices, provide the commissioning contract; 6, business quality management system, work procedures and other documents catalog. Including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents; 7, business facilities, equipment directory; 8, the enterprise has installed a computerized information management system, basic information and functional description of the information management system, print information management system home page.
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 configuration planning, and promote the rational allocation and full **** enjoyment of medical equipment in the region.