1, "Medical Device Business License Application Form".
2, the administrative department for industry and commerce issued a "notice of pre-approval of enterprise name" or "industrial and commercial business license".
3, application report.
4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's property certificate.
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 manager's identity card, a copy of the certificate of academic qualifications or title certificate and personal resume.
7, technicians search list and copies of academic and professional title certificates.
8, operating quality management specification document catalog.
9, the enterprise has installed the product purchase, sale, inventory information management system, print information management system home page.
10, storage facilities and equipment catalog.
11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the catalog of application materials and the enterprise to the material to make a commitment to bear legal responsibility for any false.
Requirements for the 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, the "Medical Device Business License Application Form" should be filled out the items should be filled out completely and accurately, fill in the content should meet the following requirements.
A, "business name", "registered address" and "industrial and commercial business license" or "pre-approved notice of enterprise name" is the same.
B, to apply for the business scope of the State Drug Administration in 2002 issued by the "Classification of Medical Devices Catalog" a directory to fill out.
C, "registered address", "warehouse address" should be filled out specific door, floor and room number.
3, the legal representative of the proof of identity, proof of academic title, appointment documents should be valid;
4, industrial and commercial administration issued by the "pre-approval of enterprise name notification" or "industrial and commercial business license" copy should be the same as the original, a copy of confirmation to retain, the original returned;
5, proof of property, proof of rental of premises (the lessor to provide proof of property rights) should be valid;
5, proof of property, proof of lease (the lessor to provide proof of property rights) should be valid;
6, "registered address", "warehouse address" fill in the specific door number, floor and room number. Proof) should be valid;
6, the person in charge of the enterprise, the resume of the quality manager, proof of education or title should be valid;
7, the enterprise should be based on its 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, the legal representative must be signed by himself.
Legal basis:
"Regulations on the Administration of Medical Institutions"
Article 10 Application for the establishment of a medical institution, the following documents shall be submitted:
(a) application for the establishment of the application;
(b) set up a feasibility study report;
(c) report on the selection of the site and architectural design Floor plan.