1, two copies of the application form, an electronic filing documents.
2, the administration for industry and commerce issued by the "pre-approval notice of enterprise name" or "business license" copy of the original and a copy.
3, application report. (Including the introduction of business personnel, scale of operation, business scope, etc.)
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, the person in charge of the enterprise, the quality manager's identity card, a copy of the certificate of academic qualifications or title certificate and personal resume.
7, list of technical staff and copies of academic and professional title certificates.
8, the operation of a catalog of quality management standardized documents, including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents;
9, the enterprise has installed the product purchase, sale and inventory information management system, print a copy of the information management system home page.
10, storage facilities and equipment catalog.
11, quality management personnel on duty self-assurance statement and the authenticity of the application materials self-assurance statement of 1, including the directory of application materials and materials made by the enterprise if the material is false to assume legal responsibility for the commitment;
12, where the application for the enterprise to declare the material, the person in charge of the handling of personnel is not legal representative or person in charge of himself, the enterprise should be submitted to the "letter of authorization" of a copy.
13, apply for a "medical device business license" confirmation