Class 3 medical device license to declare information

1, "Medical Device Business License Application Form";

2, industrial and commercial administration issued by the "pre-approval of enterprise name notification" or "industrial and commercial business license";

3, the application report;

4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's real estate certificates;

5, business premises, Warehouse layout plan.

6, the proposed approach to determine the person in charge, the person in charge of the enterprise, the quality of the person in charge of the ID card, certificate of education or title certificate copies and biographical information;

7, technical staff search list and academic qualifications, title certificates copies;

8, business quality management standardized document directory;

9, the enterprise has been installed in the product purchases, sales and storage of the information management system, print the information management system. Home.

10, warehousing facilities and equipment directory;

11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the directory of application materials and materials made by the enterprise

If false commitment to bear legal responsibility;

12, apply for a "medical device business license" confirmation.