Three types of medical equipment business license requirements for 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 in the project should be filled in completely and accurately;
3, the legal representative of the Proof of identity, proof of academic title, appointment documents should be valid;
4, industrial and commercial administration department issued a "notice of pre-approval of enterprise name" or "business license" copy should be the same as the original, the copy confirmed to be retained, the original is returned;
5, real estate certificates, proof of rental of premises (the lessor to provide proof of property rights) should be valid;
6 The person in charge of the enterprise, quality management 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, application materials should be signed by the legal representative of the authenticity of the statement of self-assurance and stamped with the official seal of the enterprise, such as the absence of an official seal, then the legal representative must be signed or signed;
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, indicate the date, stamped with the official seal of the unit; personal application shall be signed or signed;
10, the application materials should be complete, clear, signed, and stamped copy by copy!
10. All application forms should be filled in by computer typing and bound in the order of the catalog of application materials.
Legal basis: "Medical Device License" Article VI
Application for "Medical Device License" should have the following conditions:
(a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.