1. enterprise application report;
2. "Medical Device Business Enterprise License Application Form";
3. Business administration department issued by the business name pre-approval of the documents; if the branch to provide the parent company's "business license," "Medical Device Business Enterprise A copy of "Business License" and "Medical Device Business Enterprise License" and the power of attorney or power of attorney issued by the parent company;
4. A table of the situation of the person in charge of the proposed enterprise and the quality management personnel;
5. A copy of the ID card, certificate of academic qualifications or professional titles, and biography of the person in charge of the proposed enterprise and the quality management personnel;
6. A framework diagram of the organizational structure and function of the proposed enterprise;
7. Enterprise registered address, business address of the geographic location map, functional layout plan (indicating the area) and proof of property rights, lease agreements, housing rental record certificate copies;
8. Proposed enterprise warehouse geographic location map, layout plan (indicating the name of the warehouse address, floor area, area, to be inspected area, qualified products area, substandard product area, shipping area, return area and its area) and Proof of ownership of housing, lease agreements, housing lease filing certificates copies;
9. Proposed enterprise (Jining Hongyi Company) product quality management system documents;
10. Enterprise business facilities, equipment, table;
11. Proposed product registration certificate, a copy of the production license;
12. Where the application for the enterprise to declare the material, the handling Personnel is not the legal representative or person in charge himself, the enterprise should submit a "power of attorney";
13. Declaration of the authenticity of the materials commitment.