Medical device business license application materials
1, "Shanghai Medical Device Business License Application Form"
2, "Medical Device Business License Application Materials Registration Form"
3, industrial and commercial administration department issued by the enterprise name pre-approval documents or "business license" (copy)
4, the proposed enterprise quality management personnel, quality officer, quality inspector (ID card, academic or title certificate copy, personal resume, contact phone number)
1) enterprise quality management personnel
2) enterprise A quality officer (3) enterprise quality inspector a(quality management organization responsible for full-time quality officer, enterprise quality inspectors should have their business product categories related (medical devices, medicine, pharmacy) professional qualifications, familiar with the state and the city of the supervision and management of medical devices related to the laws and regulations, regulations and technical standards).
5, the proposed enterprise office space and warehouse office facilities and storage equipment list
6, the proposed enterprise quality management organization network diagram
7, the proposed enterprise organization and function or full-time quality management personnel functions
8, the proposed enterprise product quality management system documents and record forms