2. "Regulations for the Supervision and Administration of Medical Devices" (Chinese People's **** and the State Council Decree No. 276, Article 24)
3. "Medical Device License" (State Food and Drug Administration Decree No. 15, Article 3 to Article 4, Article 6 to Article 16)
3. (State Food and Drug Administration Decree No. 15, Articles 3 to 4, Articles 6 to 16)
4. "On the issuance of in vitro diagnostic reagents business enterprises (wholesale) acceptance criteria and start-up application procedures notice (State Food and Drug Administration City [2007] No. 299)"
5. "In vitro diagnostic reagents business enterprises (wholesale) acceptance criteria"
6. "Beijing Medical Device Business Enterprise Inspection Acceptance Criteria (Beijing Drug Administration issued [2011] No. 39)
Charges: no charge
Term: 30 working days from the date of acceptance (excluding the delivery period)
Acceptance: the city administrative area to apply for the opening of the "Medical Device Business License" issuance of the business registered by the enterprise where the business is located in the Municipal Bureau of Pharmaceutical Supervision branch acceptance.
Licensing procedures:
Application and acceptance
Enterprises log on to the Beijing Municipal Drug Administration enterprise service platform for online reporting, the enterprise in accordance with the provisions of the scope of acceptance, the following application materials need to be submitted:
1. "Medical Device Business License Application Form"
2. industrial and commercial administrative departments issued by the "Enterprise Name pre-approval notice" or "business license" original and copies; (check the original)
3. Quality management personnel ID card, academic or title certificate original and copies and resume; (check the original)
4. Organization and function;
5. Registered address (the business address of the enterprise) and warehouse address of the geographic location map and Floor plan (indicating the area) and a copy of the proof of property rights and the right to use the house;
6. Product quality management system document catalog;
7. Operating in vitro diagnostic reagents of the enterprise should also submit the following application materials:
① Proposed legal representative of the enterprise, the person in charge of the enterprise, a copy of the certificate of academic qualifications and resume; (check the originals)
② Licensed pharmacist qualification certificate and the original letter of appointment, a copy; (check the original)
③ competent inspector certificate, a copy of the letter of appointment and or a copy of the certificate of inspection of the relevant professional university degree or above and engaged in inspection-related work for more than 3 years of work experience; (check the original)
④ the scope of the products to be operated;
⑤ the proposed business premises, equipment, storage facilities and the surrounding health environment and so on. and the surrounding health environment, etc.;
⑥ proposed enterprise quality management documents and warehousing facilities, equipment directory;
8. Self-assurance statement of the authenticity of the declared materials, and the materials to make a commitment to bear legal responsibility for any false;
9. Where the application for the enterprise to declare the materials, the applicant is not a legal representative or the person in charge of the person himself, the enterprise should be submitted to the "Authorized Power of Attorney".
Standards:
1. The application materials should be complete, clear, required to sign the signature must be signed, stamped with the official seal of the enterprise. Printed or copied on A4 paper, bound in accordance with the order of application materials;
2. Where the application materials need to submit a copy, the applicant shall date the copy, stamped with the official seal of the enterprise;
3. Verify that the enterprise to submit the "Medical Device Business License Application Form" whether the signature of the legal representative and stamped with the official seal of the enterprise (if any);
4. Verify that the "medical device business license application form" should be filled out the items should be filled out completely and accurately, fill in the content should meet the following requirements:
"Business name" and "business license" or "pre-approval of enterprise name notification" is the same;
5. Verify that the enterprise's legal representative, the person in charge of the enterprise, Quality management personnel ID card, proof of academic title, qualification certificates, the validity of the appointment documents. Copies confirmed to be retained, the original is returned;
6. A copy of the "Notice of Pre-approval of Enterprise Name" or "Business License" issued by the Administration for Industry and Commerce shall be the same as the original. Copies confirmed to be retained, the original is returned;
7. Proof of property rights, the right to use the house should be valid;
8. Check the product quality management system directory, including procurement, purchase and acceptance of goods, warehousing, storage and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
9. Medical device business scope should be in line with the provisions of the Classification Directory of Medical Devices Management category, class code name;
10. Self-assurance statement of the authenticity of the declared materials should be signed by the legal representative and stamped with the official seal of the enterprise, or if there is no official seal, the legal representative must sign or sign.
Position Responsible Person: Branch Receiver
Responsibilities and Authorities:
1. Check the application materials in accordance with the standards.
2. The application materials are complete, meet the formal review requirements, should be accepted in a timely manner, fill out the "Notice of Acceptance", the "Notice of Acceptance" will be handed over to the applicant as a proof of acceptance.
3. The application materials submitted by the applicant is incomplete or does not meet the formal review requirements, the acceptance of the applicant should be advised on the spot to make corrections to the materials, fill out the "Notice of Corrections", indicating that the content has been and needs to be corrected. Acceptance of the content of the applicant can not be informed on the spot need to make corrections, should fill out the "receipt of material vouchers" handed to the applicant, within five working days to issue a "Notice of Corrective Material", informing the applicant to make corrections to the relevant materials.
4. The application does not fall within the purview of the department or the application does not require administrative licensing, inadmissible, fill out the "Notice of Inadmissibility".
Term: 2 working days
Two, audit
Standard:
(a) Material Review:
In accordance with the "Beijing Medical Device Business Inspection and Acceptance Standards," "In Vitro Diagnostic Reagent Business (Wholesale) Acceptance Criteria," the review of the application materials.
(B) on-site inspection:
Should comply with the "Beijing Medical Device Business Enterprise Inspection and Acceptance Standards", "in vitro diagnostic reagent business enterprises (wholesale) acceptance criteria.
(C) Audit Opinions
Issue audit opinions.
Position Responsibility: Market Supervision Section or Medical Device Supervision Section auditors
Responsibilities and authority:
(A) material review
Application materials in accordance with the "Beijing Medical Device Business Inspection and Acceptance Criteria," "In Vitro Diagnostic Reagent Business (Wholesale) Acceptance Criteria" for the review.
(B) on-site inspection
In accordance with the "Beijing Medical Device Business Enterprise Inspection and Acceptance Standards", "in vitro diagnostic reagent business enterprises (wholesale) acceptance criteria" for the on-site inspection of the enterprise, by the Market Supervision Section or the Medical Devices Supervision Section is responsible for organizing the supervision of the site inspection of more than two (including two), fill in the "Medical Device Business Enterprise License Review Form" and Signed by the person in charge of the enterprise (or authorized) to sign on the spot to confirm.
(C) review comments
1. meet the standards, the audit opinion of the permit, the application materials and audit opinions and transfer the review;
2. do not meet the standards, the opinions and reasons for not permitting the application materials and audit opinions and transfer the review of the personnel.
Term: 22 working days
Three, review
Standards:
1. Procedures should be in line with the requirements set out;
2. Completed within the specified time limit;
3. Confirmation of the review of the material review comments and the results of the on-site review.
Position Responsibility: Market Supervision Section or Medical Device Supervision Section Chief.
Job responsibilities and authority:
1. Review in accordance with the review criteria.
2. Agree with the reviewer's opinion, put forward the review opinion, together with the application materials to the reviewer.
3. Disagree with the reviewer's opinion, should be exchanged with the reviewer, put forward the review opinion and reasons, and application materials together with the validator.
Duration: 3 working days
Four, validation
Standards:
1. Confirmation of the review opinion;
2. Issuance of the validation opinion.
Position Responsible Person: Branch Director in charge of
Position Responsibilities and Authority:
1. Validation in accordance with the validation criteria.
2. Agree with the reviewer's opinion, sign the validation opinion, and application materials together with the transfer or medical device regulatory section reviewers.
3. Do not agree with the reviewer's opinion, should be exchanged with the reviewer, put forward the validation opinion and the reasons for the application materials together with the transfer or the Medical Devices Regulatory Section reviewers.
Term: 3 working days
V. Administrative licensing decisions
Standards:
1. Acceptance, audit, review and validation of personnel in the licensing instruments, such as the complete signature;
2. A full set of application materials to meet the prescribed requirements;
3. Licensing instruments, such as conformity with the requirements of the official documents;
4. Medical Device Business License" is complete, correct and valid, the format, text, stamped Beijing Municipal Drug Administration official seal is accurate and error-free;
5. The production of the "decision not to grant administrative licenses" shall state the reasons, while informing the applicant of the law the right to apply for administrative reconsideration or administrative litigation, as well as complaint channels.
Job Responsibility: Market Supervision Section or Medical Device Supervision Section auditors
Job Responsibilities and Authorities:
Make the "Medical Device License", stamped with the official seal of the Beijing Municipal Drug Administration, and the "Medical Device License" copy of the original copy of the file with the archives. Or make "not administrative license decision", stamped with the official seal of the Beijing Municipal Drug Administration, while informing the applicant of the right to administrative reconsideration or administrative litigation in accordance with the law, as well as complaint channels.
VI, delivery
Standard:
1. Computer system SMS notification of the applicant license results, with the "Notice of Acceptance" issued "Medical Device Business License" or "No Administrative License Decision";
2. Delivery of the window in the "delivery receipt" on the signature, date, stamped Beijing Municipal Drug Administration administrative licensing Special seal accurate and error-free.