Based on the "Medical Device Business License Management Measures" (Bureau Decree No. 15) of the provisions of the medical device business license need to provide the following information:
1, "Medical Device Business License Application Form";
2, industrial and commercial administration issued by the "pre-approval of the enterprise name notice" or "industrial and commercial business license";
3, application report;
4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's property certificates;
5, business premises, warehouse layout plan;
6, the proposed approach to determine the person in charge of the person responsible for the business, the person in charge of the enterprise, the quality of the person responsible for quality management of the identity card, proof of academic qualifications or professional title and a copy of proof of the personal resume;
7, list of technical staff and copies of academic and professional title certificates;
8, business quality management standardized document catalog;
9, the enterprise has been installed in the product purchasing, sales, inventory information management system, print the information management system home page;
10, warehousing facilities and equipment directory;
11, the quality management personnel in the post self Guarantee statement and self-assurance statement of the authenticity of the application materials, including the directory of application materials and the enterprise to the material to make a commitment to bear legal responsibility if false;
12, where the application for the enterprise to declare the material, the processing staff is not the legal representative or person in charge of the person himself, the enterprise should submit the "letter of authorization";
13, apply for a "Medical Device Business License Confirmation.
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