(a) reporting conditions
1. enterprises should have with the scale and scope of operation of the quality management organization or full-time quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;
2. enterprises should have with the scale and scope of operation of the business is relatively independent of the business premises;
3. enterprises should have with the scale and scope of operation of the storage conditions, including with the medical equipment manufacturing license.
3. Enterprises should have with the scale and scope of business appropriate storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of medical equipment products;
4. Enterprises should establish and improve product quality management system, including purchasing, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
5. Enterprises should have its business with the medical device products appropriate technical training and after-sales service capacity, or agreed by the third party to provide technical support;
6. To operate implantable (interventional) class medical devices, should also be equipped with a college or intermediate title or above professional health professionals and technicians; to operate with special requirements for medical devices, should also be equipped with the relevant professional college or above education or primary title or above. Above education or junior title of health technicians.
(B) declaration materials (in duplicate)
1. for "medical device business license" application report;
2. industrial and commercial administration issued by the "pre-approval of the enterprise name notice" or "business license" (copy); to provide "pre-approval of the enterprise name notification" need to provide "pre-registration of the enterprise name application";
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3. has filled out the "medical device business license application form";
4. to do business according to the "Zhejiang Province, medical device business on-site inspection score sheet" of the self-inspection and the legal representative or person in charge of the opinion signed;
5. to do business with the legal representative of the legal representative of the person in charge of the enterprise's identity card (copy) and the decision on the appointment and dismissal of personnel documents
6. Proposed enterprise organization chart, functions and staff roster;
7. Proposed enterprise responsible for quality management agencies or quality management personnel and the main professional and technical personnel of the academic qualifications or titles of documents, identity cards (copies), personal resume and full-time full-time commitment to myself;
8. Proposed technical training and after-sales service personnel of the enterprise Academic or professional title documents, identity cards and related training certificates (copy);
9. Proposed business registration, storage site of the relevant certificates (geographic location map, house plans, property rights or the lessor's certificate of property rights and a copy of the lease agreement);
10. Proposed business quality management system of the list of the list of texts, related records, sample forms and storage facilities, equipment inventory (copy) (copy);
11. Submitted to declare the authenticity of the information self-assurance statement (signed by the legal representative, has obtained a business license enterprise stamped with the enterprise seal);
12. Branches of legal entities are also required to provide the parent company or head office of the "Medical Device Business License" (copy) and signed by its legal representative of the authorization of the certificate;
13. Drug business enterprises are also required to provide "Drug License";
14. Business equipment class of medical devices, need to have a clear product installation, maintenance, training services signed with the supplier of the responsibility of the agreement. If the business enterprise to carry out installation, maintenance, training services for customers, provide the manufacturer's authorization.
15. Business implantation (intervention) class of devices, the need for its manufacturers, distributors or agents to issue a letter of authorization or the two sides initialed the agreement;
16. Operation of disposable sterile medical devices, the need to provide personnel health records;
17. Other documents to be provided.
(C) for the program
The applicant should be made to the provincial Food and Drug Administration licensing application, and submit application materials.
1. Acceptance of information. Acceptance of the application materials for formal review of the hall, the application belongs to the department's terms of reference, the application materials are complete, in accordance with the statutory form, or the applicant in accordance with the requirements to submit all corrective application materials, issued a "notice of acceptance. Notice of acceptance" should be stamped with the acceptance of the special seal and indicate the date of acceptance.
2. On-site inspection. On-site inspection organized by the provincial bureau or commissioned by the municipal bureau. In accordance with the "Zhejiang Province, medical equipment business enterprises on-site inspection score sheet", on-site inspection of enterprises.
3. Review decision. After the on-site inspection, the review meets the standards, to make a decision to grant the issuance of "medical device business license", within 10 days of the date of the decision to the applicant issued "medical device business license" (including in the provincial government website for 5 days of publicity period), and through the Provincial Bureau of the government website for publicity. The approved scope of business according to the application of the enterprise, on-site inspection of the final conclusion of the comprehensive approval.
After reviewing the conditions do not meet the requirements, a written explanation of the reasons and return all the application information. At the same time to inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.