How to write the catalogue of products to be operated when applying for in vitro reagents?

The address change of medical device enterprises must be filed with the Food and Drug Administration! You can't go directly to the industrial and commercial bureau. All medical device projects have pre-approval projects. Give you a website reference. 38-7-02_ Medical Device Business License (Category II and III) Change of registered address (referring to the registered business address of the enterprise), warehouse address and business scope June 0, 2008 1 Name of licensed project: Medical Device Business License (Category II and III) Change of registered address (referring to the registered business address of the enterprise), warehouse address and business scope No. People's Republic of China (PRC) administrative licensing law. Regulations on the Supervision and Administration of Medical Devices (Article 24 of Order No.276 of the State Council of People's Republic of China (PRC) * * People's Republic of China) 3. Measures for the Administration of Medical Device Business License (Articles 3, 4, 6, 7, 9 to 23 of OrderNo. 15 of the US Food and Drug Administration) 4 .5. Interim Provisions of Beijing Municipality on Implementing the Administrative Measures for Medical Device Business License (J.D.J.F. [2005] 10). Inspection and Acceptance Standard of Medical Device Enterprises in Beijing (J.D.J.F. [2005] No.22) 6. Notice on Printing and Distributing the Inter-provincial Warehouse Supervision System for Medical Device Enterprises (Guo Fa [2006] No.223) 7. Notice on Printing and Distributing the Acceptance Criteria and Opening the Declaration Procedures for Medical Device Enterprises (Guo) No.299) Fees: No-charge period: 20 working days from the date of acceptance (excluding delivery date) Acceptance scope: municipal drugs registered by enterprises. License program: 1. Enterprises accepting applications log on to the enterprise service platform of Beijing Drug Administration for online declaration. According to the provisions of the scope of acceptance, the enterprise is required to submit the following application materials (if the changes involve immediate changes, the materials required for immediate changes should also be provided): 1. Application Form for Change of Medical Device Business License (please fill in and print it on the website of Beijing Drug Administration); 2. The original, duplicate and photocopy of the Medical Device Business License; 3. Original and photocopy of business license; 4.( 1) If the registered address (referring to the registered business address of the enterprise) or the warehouse address is changed, the following documents shall be submitted: ① the geographical location map, floor plan (indicating the area) of the registered address and warehouse address, the original and photocopy of the house ownership certificate (or lease agreement); Where the warehouse address is changed, a catalogue of storage equipment and facilities shall be submitted at the same time; Where an enterprise uses centralized warehouse to store products, it is required to submit the business license of enterprise as a legal person, the License for Medical Device Business and the description of centralized warehouse (it is not necessary to submit the house title certificate or lease agreement of the warehouse, the location map and floor plan of the warehouse address); (2) If a warehousing enterprise is to be established across provinces, it is also required to submit the ID card, copy of education or professional title certificate and description of warehousing conditions of the warehousing quality inspector to be established. (2) If the business scope is changed, it shall also be submitted as follows: ① A copy of the registration certificate of the product to be operated; ② Catalogue of storage equipment and facilities; (3) If it is necessary to change the business scope and add warehouses according to the Acceptance Specification for Medical Device Enterprises in Beijing and the Acceptance Specification for in vitro Diagnostic Reagents Enterprises (Wholesale), submit the original and photocopy of the warehouse property right certificate or lease agreement, the geographical location map and floor plan of the warehouse address (indicating the area and functional layout); (4) If it is necessary to change the business scope and increase the number of quality management personnel according to the Acceptance Standard for Medical Device Enterprises in Beijing and the Acceptance Standard for in vitro Diagnostic Reagents Enterprises (Wholesale), the identity certificate, academic certificate or professional title certificate of the quality management personnel and their copies and resumes shall be submitted; To increase the operation of in vitro diagnostic reagents, the original and photocopy of licensed pharmacist qualification, certificate of inspector in charge, letter of appointment or certificate of bachelor degree or above in laboratory science, and proof of work experience of more than 3 years in laboratory related work shall be submitted at the same time; The enterprise shall also submit the personnel appointment and dismissal decision or the resolution of the board of directors; ⑤ Enterprises that increase the operation of in vitro diagnostic reagents should also submit: a. The originals, photocopies and resumes of the legal representative and responsible person of the enterprise; B the original and photocopy of the geographical location map, floor plan (indicating the area and functional layout) of the registered address of the enterprise. C business premises, equipment, storage facilities and surrounding sanitary environment, etc. ; 5. A self-assurance statement on the authenticity of the application materials, including the enterprise's commitment to bear legal responsibility for the falsehood of the materials; 6. If the applicant is not the legal representative or the person in charge, the enterprise shall submit 2 copies of the power of attorney. Standard: 1. The application materials shall be complete and clear, and shall be signed if necessary, and each copy shall be stamped with the official seal of the enterprise. Print or copy it on A4 paper, and bind it into volumes in the order of application materials; 2. If the application materials need to be copied, the applicant shall indicate the date on the copy and affix the official seal of the enterprise; 3. The "Application Form for Change of Medical Device Business License Project" submitted by the enterprise shall be signed by the legal representative and stamped with the official seal of the enterprise; 4. The items in the Application Form for Change of Medical Device Business License shall be complete and accurate, and the "enterprise name" shall be consistent with the "business license"; 5. A copy of the business license is consistent with the original. Copy confirmed retained, the original returned; 6. The house title certificate and house lease certificate are valid. Copy confirmed retained, the original returned; 7. Where an enterprise centrally stores products, it shall check whether the warehouse address declared by the enterprise is consistent with the warehouse address marked in the Medical Device Business License of the enterprise as a legal person; 8. Whether the product registration certificate is consistent with the increased business varieties and whether it is within the validity period; 9 to verify whether the medical device business enterprise has been investigated by the drug supervision and administration department and has not yet closed the case; 10. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. Person-in-charge of post: post responsibility and authority of the personnel accepted by the branch office: 1. Check the application materials according to the standards. 2. If the application materials are complete and meet the requirements of formal examination, it shall be accepted in a timely manner, and the Notice of Acceptance shall be filled in and handed over to the applicant as an acceptance certificate. 3. If the application materials submitted by the applicant are incomplete or do not meet the requirements of formal examination, the accepting personnel shall inform the applicant to supplement the relevant materials at one time on the spot, fill in the Notice of Supplementary Materials, and indicate the contents that have been supplemented and need to be supplemented. If the accepting personnel cannot inform the applicant of the contents that need to be corrected on the spot, they shall fill in the Certificate of Accepted Materials and submit it to the applicant, and issue the Notice of Corrected Materials within five working days to inform the applicant to correct the relevant materials. 4. If the application matters do not fall within the scope of authority of the department or the application matters do not need administrative license, it will not be accepted, and a notice of rejection will be filled out. 5. For the medical device enterprises that have been investigated by the drug supervision and administration department and have not yet closed the case, fill in the Notice of Suspension of Acceptance. Duration: 2 working days. Audit standard: (1) Material audit Review the application materials according to the audit standard. (2) On-site inspection 1 shall conform to Beijing Inspection and Acceptance Standard for Medical Device Enterprises and Acceptance Standard for in vitro Diagnostic Reagents Enterprises (Wholesale). 2. The food and drug supervision and administration department at the place where the additional warehouse is located shall assist in the on-site inspection of the warehouse in accordance with local standards, determine the results of the on-site inspection, and fill in the feedback letter of the inspection results. (3) Issue an audit opinion. Person in charge of the post: the post responsibilities and authority of the auditor of the market supervision department or the medical device department: (1) Material audit Review the application materials according to the audit standards. (2) on-site inspection 1. The on-site inspection of the enterprise shall be conducted in accordance with the Inspection and Acceptance Standard of Beijing Medical Device Enterprise and the Acceptance Standard of in vitro Diagnostic Reagent Enterprise (Wholesale). On-site inspection shall be conducted by two or more personnel, and the Medical Device Enterprise Review Form shall be filled in and signed, and the person in charge of the enterprise (or authorized person) shall sign on the spot for confirmation. In line with the standards, put forward the approval of the audit opinion; Do not meet the standards, put forward opinions and reasons for disapproval. 2. For enterprises with additional warehouses across provinces, the drug regulatory department at the warehouse location shall assist in on-site acceptance and issue a feedback letter on the acceptance results. Duration: 13 working days. Review standard: 1. The procedure meets the specified requirements; 2. Complete within the prescribed time limit; 3. Confirm the material audit opinions, on-site audit results and cross-provincial and municipal acceptance results feedback letter. Person in charge: person in charge of market supervision department or medical device department. Responsibility and authority: 1. Review the application materials and audit opinions of the enterprise according to the evaluation criteria. 2. Agree with the auditor's opinion, and put forward the audit opinion to the auditor. 3 do not agree with the auditor's opinion, after exchanging views with the auditor, put forward the review opinions and reasons to submit the application materials to the examiner. Duration: 2 working days. Four. Approval standard: 1. Confirm the audit opinions and inter-provincial "acceptance result feedback letter"; 2. Issue examination and approval opinions. Person-in-charge of post: Director in charge of sub-bureau. Responsibility and authority: 1. Examine and approve the application materials of the enterprise according to the examination and approval standards. 2. Agree with the opinions of the examiners and sign the examination opinions; Do not agree with the reviewer's opinion, after exchanging opinions with the reviewer, put forward the review opinions and reasons. 3 do not agree with the reviewer's opinion, after exchanging opinions with the reviewer, put forward the examination and approval opinions and reasons, and transfer the application materials to the market supervision department or the auditor of the medical device department. Duration: 3 working days. 5. Decision criteria of administrative license: 1. Acceptance, examination, examination and approval personnel have complete signatures on the license documents; 2. A complete set of application materials meets the specified requirements; 3. The license documents meet the requirements of official documents; 4. The content of the Medical Device Business License is complete, correct and effective, the format and text are correct, and the official seal of Beijing Drug Administration is accurate; The changes in the copy are consistent with the original; 5. The decision not to grant administrative license shall explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law and the complaint channels; 6. Retained and archived materials are complete and standardized. Person in charge of post: auditor of market supervision department or medical device department; post responsibilities and authority: 1. If the license is granted, the original of the Medical Device Business License shall be made and filled in the change column of the copy of the Medical Device Business License. 2. If the license is not granted, a Decision on Not Granting Administrative License shall be made and stamped with the official seal of Beijing Drug Administration. 6. Service standard: 1. Inform the applicant to bring the original of the Acceptance Notice and the original of the Medical Device Business License, and issue the original and modified version of the newly issued Medical Device Business License or the Decision of No Administrative License with the Acceptance Notice; Withdraw the original medical device enterprise license; 2. Withdraw the original Medical Device Business License. Person in charge of post: Time limit for window personnel to deliver to branches: 10 working days (not included in the total time limit).