1, the legal representative of the enterprise, the person in charge of the enterprise, 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 of operation and the 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 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 "Hubei Province, the opening of medical device business acceptance of the implementation of standards" acceptance.
Applicants submit materials directory:
Data No. 1, "Medical Device Business License Application Form", "Medical Device Business License.
Data No. 2, "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the Administration 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.
Data 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 academic and professional title certificates.
Data No. 8, business quality management standardized document catalog.
Data No. 9, the enterprise has been installed in the product purchase, sale, inventory information management system, print 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 directory of application materials and the enterprise to the material to make a commitment to bear legal responsibility if false;
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, apply for a "medical device business license" confirmation letter