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 business name pre-approval of documents or "business license" ( Copies)
4, the proposed enterprise quality management personnel, quality officer, quality inspector (ID card, academic or title certificate copies, personal resume, contact phone number)
(1) the person in charge of quality management of an enterprise
(2) an enterprise quality officer (3) an enterprise quality inspector(quality management organization, the person in charge of a 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's supervision and management of medical devices related laws and regulations and technical standards).
5, the proposed enterprise office space and warehouse office facilities and warehousing equipment list
6, the proposed enterprise quality management organization network diagram
7, the proposed enterprise organization and functions or the functions of a full-time quality management personnel
8, the proposed enterprise product quality management system, documents and records of the form