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 situation;
2, the enterprise should have with the scale and scope of operation of the business of the quality management organization or full-time quality management personnel; quality management personnel should have nationally recognized relevant professional qualifications or titles, with professional and technical personnel qualified according to law. Quality management personnel should have nationally recognized professional qualifications or titles, with the qualification of professional and technical personnel according to law. Such as quality management should be on duty in the post, not in other units part-time
3, with the scale and scope of operation of the relatively independent business premises.
4, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
5, with technical training on business products, after-sales service capabilities.
6, should be in accordance with relevant national and local regulations, the establishment of a sound 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.
To apply for the business license for the information required:
Information No. 1, "Medical Device Business License Application Form".
Data No. 2, "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the administrative department for industry and commerce. Data No. 3, application report.
Data No. 4, supporting documents for business premises and warehouse premises, including copies of property certificates or lease agreements and property certificates of the lessor.
Information No. 5, business premises, warehouse layout plan.
Data No. 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.
Data No. 7, a list of technical staff and copies of certificates of education and professional titles.
Data No. 8, catalog of business quality management standard documents.
Data No. 9, the enterprise has installed the product purchase, sale, inventory information management system, print the information management system home page.
Data No. 10, storage facilities and equipment catalog.
Data No. 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 materials made by the enterprise if the false commitment to bear legal responsibility;
Data No. 12, where the application for the enterprise to declare the material, the processing staff is not the legal representative or person in charge of the person himself, the enterprise should submit the "letter of authorization". .
Data No. 13, application for "Medical Device Operator License" confirmation.
If there is no medical device business license, you sell privately and get caught, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" is to be fined.