How to apply for acceptance of Class II medical devices in Liaoning Province, detailed process, very urgent!!!! Thank you very much for your enthusiastic help!

Hello, a license: "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: (none) Fourth, licensing conditions: 1. The enterprise should be equipped with the appropriate title, familiar with the national and local supervision and management of medical devices, rules and regulations, with a certain management capacity; 2. Certain management capabilities of full-time personnel; 2. with the appropriate business premises and environment; 3. with the appropriate quality management personnel; 4. with the operation of the product training, maintenance and other after-sales service capabilities; 5. should be in accordance with relevant national and local regulations, the establishment of a sound and necessary management system, and strictly enforced; 6. should be collected and preserved related to the national standards of medical devices, industry standards and medical devices, supervision and management of laws, regulations and special provisions of the law. Supervision and management of laws, regulations and special provisions; 7. Specific conditions can be compared with the "Guangdong Province, medical device business enterprises on-site inspection and acceptance criteria (for trial implementation). V. Application materials: the applicant to the Provincial Food and Drug Administration to start the application, and submit the following materials: 1. "Medical Device Business License Application Form" a type of 2 copies; 2. pre-approval of the business name or a copy of the business license; 3. application report; 4. place of business, the warehouse floor plan; 5. proof of property rights or the right to use the house; 6. the proposed head 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. Quality management documents catalog; 9. Warehousing facilities and equipment directory; 10. Applicant of the authenticity of the materials submitted to the self-assurance statement. Sixth, application forms and documents to download: "Medical Device Business License Application Form"; "Medical Device Business Site Inspection and Acceptance Standards (for trial implementation)" "enterprise quality management resume" "professional and technical personnel list" can be downloaded from 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 The declaration materials should be true and 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. 2. Product range in accordance with the 2002 State Drug Administration issued the "Classification of Medical Devices Catalog" a directory to fill out. Eight, the licensing process: the applicant to the receiving 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: from the date of acceptance of the application for 30 working days Tenth, the license and the validity of the license: "Medical Device Business License", valid for five years. XI, the legal effect of the license: With the "Medical Device Business Enterprise License" to the administrative department for industry and commerce for registration. No "medical device business enterprise license" shall not operate two or three types of medical equipment products.