2 "Regulations on the Supervision and Administration of Medical Devices" (Article 24 of DecreeNo. 276th of the State Council of the People's Republic of China)
3. Measures for the Administration of Licenses for Medical Device Enterprises (Order No.3, Articles 3 to 4, Article 6 to 16). 15 of the us food and drug administration)
4. Notice on Printing and Distributing the Acceptance Criteria and Reporting Procedures for Enterprises Operating in vitro Diagnostic Reagents (No.299 [2007] of the US Food and Drug Administration)
5 "In vitro diagnostic reagent business enterprise (wholesale) acceptance standard"
6. Inspection and acceptance standard of medical device enterprises in Beijing (J.M.J.F. [2011] No.39)
Charging standard: no charge.
Duration: 30 working days from the date of acceptance (excluding delivery date)
Scope of acceptance: The application for establishing a medical device business license within the administrative area of this Municipality shall be accepted by the municipal branch of the US Food and Drug Administration where the enterprise is registered.
Licensing procedures:
I. Application and acceptance
Enterprises log on to the enterprise service platform of Beijing Drug Administration for online declaration. Enterprises shall submit the following application materials according to the prescribed scope of acceptance:
1. Application Form for Medical Device Business License
2. The original and photocopy of the enterprise name pre-approval notice or business license issued by the administrative department for industry and commerce; (Submit the original)
3 quality management personnel's ID card, education or professional title certificate and the original and photocopy of their resumes; (Submit the original)
4. Organization and functions;
5. The registered address (referring to the registered business address of the enterprise) and the geographical location map and floor plan (indicating the area) of the warehouse address, as well as a copy of the certificate of property right and use right of the house;
6. Product quality management system file directory;
7 enterprises engaged in in in vitro diagnostic reagents shall submit the following application materials at the same time:
(1) A copy of the academic qualifications and resumes of the legal representative and person-in-charge of the proposed enterprise; (Submit the original)
The original and photocopy of the qualification certificate and letter of appointment of licensed pharmacist; (Submit the original)
(3) A copy of the certificate and letter of appointment of the inspector in charge, as well as a copy of the certificate of bachelor degree or above in inspection related majors and the certificate of more than 3 years of inspection related work; (Submit the original)
(4) Scope of business products;
(5) The business premises, equipment, storage facilities and surrounding sanitary environment to be established;
⑥ Quality management documents and storage facilities and equipment catalogue of the proposed enterprise;
8. Self-assurance statement on the authenticity of the declaration materials, and promise to bear legal responsibility for the falsehood of the materials;
9. If the applicant is not the legal representative or person in charge when the enterprise applies for the materials, the enterprise shall submit a power of attorney.
Standard:
1. The application materials should be complete and clear. If required, they should be signed one by one and 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. Check whether the Application Form for Medical Device Business License submitted by the enterprise is signed by the legal representative and stamped with the official seal of the enterprise (if any);
4. Check that the items filled in the Application Form for Medical Device Business License should be complete and accurate, and the contents filled in should meet the following requirements:
"Enterprise name" is the same as the business license or the Notice of Pre-approval of Enterprise Name;
5 check the validity of the legal representative, the person in charge of the enterprise and the quality management personnel's ID card, education and professional title certificate, qualification certificate and employment documents. Copy confirmed retained, the original returned;
6. A copy of the Notice of Pre-approval of Enterprise Name or Business License issued by the administrative department for industry and commerce shall be consistent with the original. Copy confirmed retained, the original returned;
7. Proof of house property right and use right shall be valid;
8. Check the catalogue of product quality management system, mainly including procurement, incoming goods acceptance, warehousing, outbound review, quality tracking system and adverse event reporting system. ;
9. The business scope of medical devices shall conform to the management category and category code specified in the Classification Catalogue of Medical Devices;
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. If there is no official seal, it shall be signed or sealed by the legal representative.
Person-in-charge of post: accepting personnel of sub-bureau.
Job responsibilities and authority:
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 a 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.
Duration: 2 working days
Second, auditing.
Standard:
Material review:
According to the "Beijing Medical Device Enterprise Inspection and Acceptance Standard" and "In vitro Diagnostic Reagent Enterprise (Wholesale) Acceptance Standard", the application materials shall be reviewed.
(2) On-site inspection:
Should comply with the "Beijing medical device business enterprise inspection and acceptance standards", "in vitro diagnostic reagent business enterprise (wholesale) acceptance standards".
(3) Audit opinions
Issue an audit opinion.
Person in charge of post: auditor of market supervision department or medical device supervision department.
Job responsibilities and authority:
(a) material audit
According to the "Beijing Medical Device Enterprise Inspection and Acceptance Standard" and "In vitro Diagnostic Reagent Enterprise (Wholesale) Acceptance Standard", the application materials shall be reviewed.
(2) On-site inspection
According to the Inspection and Acceptance Standard of Medical Device Enterprises in Beijing and the Acceptance Standard of in vitro Diagnostic Reagent Enterprises (Wholesale), the market supervision department or the medical device supervision department is responsible for organizing more than two supervisors to conduct on-site inspection, filling out the Examination Form of Medical Device Enterprise License and signing it, and the person in charge (or authorized person) of the enterprise will sign it on the spot for confirmation.
(3) Audit opinions
1. If it meets the standards, put forward examination and approval opinions, and forward the application materials and examination and approval opinions to the reviewer;
2 do not meet the standards, put forward opinions and reasons for disapproval, and transfer the application materials and audit opinions to the reviewers.
Duration: 22 working days
Third, review.
Standard:
1. The program shall meet the specified requirements;
2. Complete within the prescribed time limit;
3. Confirm the material review opinions and on-site review results.
Person-in-charge: Chief of Market Supervision Department or Medical Device Supervision Department.
Job responsibilities and authority:
1. Review according to the review criteria.
2. Agree with the reviewer's opinions, put forward the review opinions, and forward them to the reviewer together with the application materials.
3 do not agree with the auditor's opinion, should exchange views with the auditor, put forward the review opinions and reasons, and submit them to the examiner together with the application materials.
Duration: 3 working days
Four. examine and approve
Standard:
1. Confirm the review opinions;
2. Issue examination and approval opinions.
Person in charge of post: Director in charge of branch bureau
Job responsibilities and authority:
1. Approve according to the approval criteria.
2. Agree with the reviewer's opinion, sign the review opinion, and transfer it to the reviewer of the medical device supervision department together with the application materials.
3 do not agree with the examiner, should exchange views with the examiner, put forward the examination opinions and reasons together with the application materials or medical device supervision department audit opinion.
Duration: 3 working days
Verb (abbreviation of verb) administrative licensing decision
Standard:
1. Acceptance, examination, reexamination and examination personnel shall sign the license documents completely;
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, and the format, words and official seal of Beijing Drug Administration are accurate;
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.
Person in charge of post: auditor of market supervision department or medical device supervision department.
Job responsibilities and authority:
Make the Medical Device Business License, affix the official seal of Beijing Drug Administration, and copy and file the original and duplicate of the Medical Device Business License. Or make a Decision on Not Granting Administrative License, affix the official seal of Beijing Drug Administration, and inform the applicant of the right to administrative reconsideration or bring an administrative lawsuit according to law and the complaint channels.
Delivery of intransitive verbs
Standard:
1. The computer system will inform the applicant of the license result by SMS, and issue the Medical Device Business License or the Decision of No Administrative License with the acceptance notice;
2. The signature, date and special seal for administrative license of Beijing Drug Administration of the service window personnel on the Service Receipt are accurate.