What is needed to apply for a medical device business license and the detailed operating procedures

A license content "medical device business license" Second, set the legal basis for licensing 1. "Regulations for the Supervision and Administration of Medical Devices"; 2. "Medical Device Business License Management Measures". Third, the number of licenses no Fourth, the license conditions 1. enterprises should be equipped with appropriate titles, familiar with national and local supervision and management of medical devices, rules and regulations, with a certain management capacity of the full-time staff; 2. with the appropriate business premises and environment; 3. with the appropriate quality management personnel; 4. with the management of the product training, maintenance and other after-sales service capabilities; 5. should be based on national and local regulations, the establishment of a sound and comprehensive management of essential equipment. According to national and local regulations, the establishment of a sound and necessary management system, and strictly enforced; 6. 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; 7. Specific conditions can be compared to the "Guangdong Province, medical device business on-site inspection and acceptance criteria (for trial implementation)".　　V. Application materials applicants to the Provincial Food and Drug Administration to start an application, and submit the following materials: 1. "Medical Device Business License Application Form" a type of 2 copies; 2. business name pre-approval notice or a copy of the business license; 3. application report; 4. business premises, warehouse floor plans; 5. proof of property rights or the right to use the house; 6. the proposed person in charge of the enterprise, the quality of the manager's Identity card, academic qualifications or certificates of title and personal resume; 7. List of technical staff and academic qualifications, certificates of title; 8. Catalog of quality management documents; 9. Catalog of warehousing facilities and equipment; 10. Applicant for the authenticity of the materials submitted to the self-assurance statement. Sixth, the application form and documents to download the "Medical Device Business License Application Form"; "Guangdong Province, the medical device business on-site inspection and acceptance criteria (for trial implementation)" "enterprise quality management resume" "list of professional and technical personnel" can be downloaded in the Provincial Food and Drug Administration website (www.gdda.gov.cn) VII, the material requirements 1. the declaration materials should be true, complete, with A4 paper printing or copying, and stamped with the official seal or signature of the legal representative, in order to bind the book. 2. Product scope in accordance with the State Drug Administration in 2002 issued by the "Classification of Medical Devices Catalog," a directory. Eight, the licensing process applicants to the acceptance window to submit application materials ---- acceptance ---- Provincial Food and Drug Administration to organize on-site inspection ----- Provincial Food and Drug Administration for approval ---- window to receive the results of the approval Nine, the licensing time limit since the date of acceptance of the application for 30 working days