1. "Class II Medical Devices Business Record Form" (need to log in the medical device production and operation license filing information system Self-printing);
2. A copy of the business license (can be verified online);
3. Legal representative, responsible person for the enterprise, responsible person for the quality of the identity card, education or title of the original, a copy of the certificate;
4.
4. organization and departmental setup;
5. business scope, business mode description;
6. business premises, warehouse address geographic location map, floor plan layout, housing ownership documents or lease agreement (with housing ownership documents);
7. business facilities, equipment directory;
8. quality management system, working procedures and other documents directory;
9. business quality management system, working procedures and other documents directory. Management system, work procedures and other documents;
9. Authorization letter.