1, the enterprise to apply for "Medical Device Business License" report
2, "Medical Device Business License Application Form"
3, industrial and commercial administration department issued by the business name pre-approval of documents; if the branch to provide the parent company's "Business License", "Medical Device Business License" copy and the parent company issued a letter of authorization or power of attorney √
4, the proposed enterprise responsible person and quality management personnel table
5, the proposed enterprise responsible person and quality management personnel ID card, copy of the certificate of academic qualifications or professional titles and personal resume
6, the proposed enterprise organization and functional framework
7, the proposed enterprise organizational and functional framework chart
7, the proposed enterprise organization and functional framework chart
8, the proposed enterprise organization and functional framework chart
9, the proposed enterprise organization and functional framework chart
7, the proposed enterprise registered address, business address of the geographic location map, functional layout plan (indicating the area) and proof of ownership of housing, lease agreements, housing lease filing certificates a copy of
8, the proposed enterprise warehouse location map, layout map (indicating the name of the warehouse address, floor area, area, to be inspected area, qualified products area, substandard goods area, shipping area, Return area and its area) and a copy of the certificate of property rights, lease agreement, housing lease record certificate;
9, the proposed enterprise product quality management system documents
10, business facilities, equipment table
11, the proposed product registration certificate, a copy of the production license
12, where the application for the enterprise to declare the material for the personnel Not the legal representative or person in charge himself, the enterprise should submit a "power of attorney";
13, the authenticity of the declaration materials commitment.
Remarks: 1, where the application materials need to submit a copy, the applicant shall indicate on the copy of the words "this copy is consistent with the original" or text description, indicate the date, stamped with the official seal of the unit; personal application shall be signed or sealed. 2, the application materials should be complete, clear, signed, and stamped one by one, all the Application form computer typing to fill in, all materials uniformly printed or copied on A4 paper, according to the order of the directory of application materials bound into a book.