Who has a complete set of handling materials for handling medical device companies, brother, thank you first > ...

1. Administrative Licensing Law of the People's Republic of China (Decree No.7 of the President of the People's Republic of China)

2. Regulations on the Supervision and Administration of Medical Devices (Article 24 of Decree No.276 of the People's Republic of China and the State Council)

3. Measures for the Administration of Medical Device Business License (State Food and Drug Administration) Articles 6 to 16)

4. Notice on Printing and Distributing the Acceptance Criteria and Application Procedures for Enterprises Operating in vitro Diagnostic Reagents (State Food and Drug Administration [27]) No.299)

5. Acceptance standard for in vitro diagnostic reagent trading enterprises (wholesale)

6. Inspection and acceptance standard for medical device trading enterprises in Beijing (J.D.J.F. [211] No.39)

Charge standard: no charge

Duration: 3 working days from the date of acceptance (excluding delivery period).

licensing procedures:

1. Application and acceptance

Enterprises log on to the enterprise service platform of Beijing Drug Administration for online declaration. According to the provisions of the scope of acceptance, enterprises need to submit the following application materials:

1. Application Form for Medical Device Business License

2. Original and photocopy of the Notice of Pre-approval of Enterprise Name or Business License issued by the administrative department for industry and commerce. (submit the original)

3. The original and photocopy of the ID card, education or professional title certificate of the quality management personnel and their resumes; (submit the original)

4. Organization and functions;

5. A copy of 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 the certificate of property right and use right of the house;

6. Product quality management system file directory;

7. An enterprise dealing in in-vitro diagnostic reagents shall submit the following application materials at the same time:

① photocopies of academic credentials and resumes of the legal representative and person-in-charge of the proposed enterprise; (submit the original)

② The original and photocopy of the qualification certificate and letter of appointment of licensed pharmacist; (submit the original)

③ Certificate of the inspector in charge, copy of the letter of appointment, and/or copy of the diploma of university degree or above in inspection-related major, and proof of more than 3 years' work experience in inspection-related work; (submit the original)

④ Scope of products to be handled;

⑤ the proposed business premises, equipment, storage facilities and surrounding sanitary environment;

⑥ the quality management documents of the proposed enterprise and the catalogue of storage facilities and equipment;

8. A self-assurance statement on the authenticity of the materials, and a commitment to bear legal responsibility for any falsehood of the materials;

9. Where the applicant is not the legal representative or the person in charge, the enterprise shall submit the Power of Attorney.

standard:

1. The application materials shall be complete and clear, and those requiring signature shall sign and affix the official seal of the enterprise one by one. Print or copy on A4 paper, and bind them into volumes in the order of application materials;

2. Where a photocopy of the application materials is required, the applicant shall indicate the date on the photocopy 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 should meet the following requirements:

The "enterprise name" is the same as the "Business License" or "Enterprise Name Pre-approval Notice";

5. check the validity of the identity cards, certificates of academic qualifications and professional titles, qualification certificates and appointment documents of the legal representative, person in charge of the enterprise and quality management personnel. Copy confirmed retained, the original returned;

6. the copy of the notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce shall be the same as the original. Copy confirmed retained, the original returned;

7. Proof of property right and right to use the house 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 name specified in the medical device classification catalogue;

1. The self-assurance statement of the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the enterprise. If there is no official seal, it must be signed or signed by the legal representative.

person in charge of the post: the receiver of the branch office

post 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 time, and the Notice of Acceptance shall be filled in and handed over to the applicant as the 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 correct the relevant materials at once on the spot, fill in the Notice of Corrected Materials, and indicate the contents that have been and need to be corrected. 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 Receiving Materials and submit it to the applicant, and issue a Notice of Correcting Materials within five working days to inform the applicant to correct the relevant materials.

4. If the application is not within the scope of authority of the department or the application does not require administrative permission, it will not be accepted, and fill in the Notice of Inaccessibility.

Duration: 2 working days

II. Criteria for review

(1) Material review:

Review the application materials according to the Inspection and Acceptance Criteria for Medical Device Enterprises in Beijing and the Acceptance Criteria for In Vitro Diagnostic Reagent Enterprises (Wholesale).

(2) On-site inspection:

It shall conform to the Inspection and Acceptance Standards of Beijing Medical Device Enterprises and the Acceptance Standards of In vitro Diagnostic Reagent Enterprises (Wholesale).

(III) Audit opinions

Issue audit opinions.

person in charge of the post: auditor of the market supervision department or the medical device supervision department

post responsibilities and authority:

(1) Material review

Review the application materials according to the Inspection and Acceptance Standards for Medical Device Enterprises in Beijing and the Acceptance Standards for In Vitro Diagnostic Reagent Enterprises (Wholesale).

(II) On-site inspection

For on-site inspection of enterprises according to Beijing Inspection and Acceptance Standard for Medical Device Enterprises and Acceptance Standard for In Vitro Diagnostic Reagent Enterprises (Wholesale), the Market Supervision Department or the Medical Device Supervision Department shall be responsible for organizing more than 2 supervisors to inspect the site, fill in and sign the Examination Form for Medical Device Enterprises, and the person in charge of the enterprise (or authorized)

(III) Audit opinion

1. If it meets the standards, put forward the audit opinion of granting permission, and forward the application materials and audit opinion to the reviewer together;

2. If it does not meet the standards, put forward opinions and reasons for disapproval, and forward the application materials and audit opinions to the reviewer.

Duration: 22 working days

III. Review

Criteria:

1. Procedures shall meet the specified requirements;

2. Complete within the specified time limit;

3. Confirm the material review opinions and on-site review results.

person in charge of post: head of market supervision department or medical device supervision department.

Job responsibilities and authority:

1. Review according to review standards.

2. if you agree with the auditor's opinion, put forward the review opinion and forward it to the auditor together with the application materials.

3. if you disagree with the auditor, you should exchange opinions 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

IV. Examination and approval

Criteria:

1. Confirm the review opinions;

2. Issue approval opinions.

person in charge of the post: director-in-charge of the sub-bureau

post responsibilities and authority:

1.

2. if you agree with the reviewer's opinion, sign the review opinion and forward it to the reviewer of the medical device supervision department together with the application materials.

3. if you disagree with the reviewer, you should exchange opinions with the reviewer, and then put forward the approval opinions and reasons together with the application materials, or forward them to the reviewer of the medical device supervision department.

Duration: 3 working days

V. Decision on administrative license

Criteria:

1. The signatures of the personnel who accept, review, review and examine the license documents are complete;

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 and correct;

5. The reasons shall be stated in the Decision on Not Granting Administrative License, and the applicant shall be informed 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

post responsibilities and authority:

Make the License for Medical Device Business, affix the official seal of Beijing Drug Administration, and copy and file the original and duplicate of the License for Medical Device Business. 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.

VI. Delivery criteria

:

1. The computer system informs the applicant of the licensing result by SMS, and issues the Medical Device Business License or the Decision of Not Granting 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 are accurate and correct.