1, the legal representative of the enterprise, the person in charge of the enterprise, quality management personnel should not be "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 titles, with the law Qualified professional and technical personnel. 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 a 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 based on 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.
Applicants submit materials directory:
Data No. 1, "Medical Device Business License Application Form. Data No. 2, the administrative department for industry and commerce issued by the "pre-approval of the enterprise name notice" or "business license". Data No. 3, application report. Data No. 4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's property certificates. 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, quality management of identity cards, certificates of qualifications or certificates of title and a copy of the personal resume. Data No. 7, a list of technical staff and academic qualifications, certificates of title copies. Data No. 8, business quality management standardized document catalog. Data No. 9, the enterprise has installed 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 materials made by the enterprise if false to assume legal responsibility for the commitment; Data No. 12, where the application for the enterprise to declare the materials, the processing officer is not the legal representative or person in charge of the person himself, the enterprise should submit the "power of attorney". Data No. 13, apply for a "medical device business enterprise license" confirmation letter
Requirements for application materials:
1, business enterprises to submit the "Medical Device Business Enterprise License Application Form" should be signed by the legal representative or stamped with the official seal of the enterprise; 2, the "Medical Device Business Enterprise License Application Form" filled out the items should be filled out completely and accurately, fill in the content should be consistent with the The following requirements. A. "Enterprise Name", "Registered Address" and "Business License" or "Pre-approval Notice of Enterprise Name" is the same. B, to apply for the scope of business issued by the State Drug Administration in 2002, "Classification of Medical Devices Catalog" a directory to fill out. C. "Registered address", "warehouse address" should be filled out specific door, floor and room number. 3, the legal representative of the identification, proof of academic title, appointment documents should be valid; 4, the administration for industry and commerce issued by the "pre-approval of enterprise name notification" or "business license" copy should be the same as the original, the copy to confirm the retention of the original is returned; 5, proof of real estate, proof of rental of housing (the lessor to provide proof of property rights) should be valid; 6, the person in charge of the enterprise, the quality of the manager's 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, the application materials should be signed by the legal representative of the authenticity of the self-assurance statement and stamped with the official seal of the enterprise, such as no official seal, 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, date, and stamped with the official seal of the unit; personal application shall be signed or stamped. 10, the application materials should be complete, clear, signed, and stamped copy by copy, all application forms computer typing to fill out, print on A4 paper, photocopying on A4 paper, according to the order of the directory of application materials in a bound volume.