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Medical device production license how to do
1. "Medical Device Manufacturing License Application Form" (must be in the information system to print the application form with a bar code);
2. Business license (residence must be located in the province), a copy of the organization code certificate;
3. .The applicant company holds the production of medical equipment registration certificate and product technical requirements (in vitro diagnostic reagent products including instructions) copy;
4. Legal representative, a copy of the identity of the person in charge of the enterprise;
5. Production, quality and technical personnel in charge of the identity of the person, academic qualifications, professional title certificate copy;
6. Production management, quality inspection positions Practitioners list of academic qualifications, titles;
7. Production site documents, including lease agreements, property certificates (or proof of right to use) copies; plant location and general layout, the main production workshop layout; special production environment requirements should also be submitted to the facilities, environment, copies of the documents;
8. The main production equipment and inspection equipment directory (two) Separate);
9. Quality management system quality manuals and procedural documents;
10. Process flow diagrams: need to specify the outsourcing of purchased parts, key processes and special processes, the production of environmental requirements of each process;
11. Proof of authorization of the operator;
12. Self-assurance of the authenticity of the application materials statement;
13. Statement of consistency between the submitted paper version and the electronic version of the materials.
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