Legal analysis: for the record of Class II medical device materials need: 1, business license and copy; 2, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity, education or title certificate; 3, list of professional and technical personnel and professional and technical personnel of the identity card, proof of education, professional title certificate; 4, the organization and departments Setting description; business scope, mode of operation 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. Warehousing commissioned by the third-party logistics of medical devices, to 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 computer 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 advancement, appropriateness and accessibility of technology, prepare plans for the allocation of large-scale medical equipment, and promote the rational allocation and full **** enjoyment of medical equipment in the region.
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