Medical device license application materials?

1, business enterprises to submit the "Medical Device Business License Application Form" should be signed by the legal representative or stamped with the official seal of the enterprise;

2, "Medical Device Business License Application Form" should be filled out the items should be filled out completely and accurately, fill in the content should be in line with the following requirements. a. "Business Name", "Registered address" and "business license" or "pre-approved notice of enterprise name" is the same. B, to apply for the scope of business issued by the State Drug Administration in 2002, "Classification of Medical Devices Catalog" a directory to fill out. C, "Registered address C. "Registered address", "warehouse address" should be filled in specific door, floor and room number.

3, the legal representative's identification, proof of academic title, appointment documents should be valid;

4, industrial and commercial administration issued by the "pre-approval of enterprise name notification" or "business license" copy should be the same as the original, the copy confirms to stay, the original is returned;

5, real estate certificates, proof of rental of premises (the lessor to provide property rights) should be valid;

5, proof of property, proof of lease (the lessor to provide property rights) should be valid;

6, "registered address", "warehouse address" fill in the first level catalog. Proof) should be valid;

6, the person in charge of the enterprise, the quality of the person in charge of the resume, proof of education or title should be valid;

7, the enterprise should be based on their own actual establishment of medical device quality management files or forms.

8, the self-assurance statement of the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the enterprise, or if there is no official seal, then the legal representative must be signed or signed in person.

9, where the application materials need to submit a copy, the applicant (unit) shall indicate on the copy of the words "this copy is consistent with the original" or text description, date, and stamped with the official seal of the unit; personal application shall be signed or stamped.

10, the application materials should be complete, clear, signed, and stamped copy by copy, all application forms computer typing to fill out, print on A4 paper, photocopy on A4 paper, according to the order of the catalog of application materials in a bound volume.