Legal analysis: 1, the legal representative of the enterprise, the person in charge of the enterprise, the quality management personnel should be no "supervision and management of medical devices regulations" Article 40 of the circumstances;
2, the enterprise should have 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 professional qualifications or professional title, with a Qualified professional and technical personnel in accordance with the law. Such as quality management personnel should be on duty, shall not be part-time in other units
3, with the scale and scope of operation of relatively independent business premises.
4, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
5, with the operating products for technical training, after-sales service capabilities.
6, should be in accordance with relevant national and local regulations, establish and improve the necessary quality management system, and strictly enforced.
7, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.
8, in accordance with the "Guangdong Province to start the medical device business acceptance of the implementation of standards" acceptance.
Legal basis: "Medical Device Business License Management Measures" Article 11 The application for "Medical Device Business License" shall be submitted as follows:
(a) "Medical Device Business License Application Form";
(b) the industrial and commercial administration department issued by the business name of the pre-approval of the supporting documents;
(c) Proposed quality management personnel of the enterprise ID card, a copy of the certificate of academic or professional title and personal resume;
(d) the proposed enterprise organization and functions;
(e) the proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), proof of ownership of the house (or lease agreement) copy;
(f) the proposed enterprise product quality Management system documents and storage facilities, equipment catalog;
(vii) the proposed business scope of the enterprise.