1: the person in charge of the enterprise shall have a secondary school education or above or a junior title or above, and understand the rules and regulations relating to the supervision and management of medical devices;
2: have a quality management organization or quality management personnel appropriate to the scope of business and scale of operation, the person in charge of the quality management organization or full-time quality management personnel shall have a professional qualification or junior title or above in a specialty related to the medical device products to be operated;
3: have a business, business, business management and management of the proposed Medical device products related to secondary school education or junior title;
3: with the scope of business and business scale of the operation, storage space; for medical equipment business premises area of not less than 20 square meters; storage area of not less than 20 square meters, shall not be located in residential housing; business address and registered address should be the same; shall not be set up in the residential housing; retail The headquarters of the chain should be set up in accordance with the scale of the warehouse, an area of not less than 60 square meters;
4: with the scope of business and the scale of operation of the storage conditions, all entrusted to other medical equipment business enterprises can not set up storage;
5: with the operation of medical equipment quality management system;
6: with the operation of the Medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations;
should not 1: shall not be forged, altered, traded, leased, loaned medical device business record certificate.
The applicant shall send the following application materials (documents, articles) to the window of the Market Supervision Bureau of the Municipal Administrative Service Center:
1: "Class II Medical Devices Business Record Form" (see Appendix B for filling in examples);
2: Copy of the business license of the enterprise;
3: Identity, education of the enterprise's legal representative or person in charge, person in charge of quality, Proof of title;
4. Description of the organization and departmental setup;
5. Business address, warehouse address of the geographic location of the map, floor plan (indicating the actual area of use), documents proving ownership of the house or lease agreement (with documents proving ownership of the house) a copy of the copy of;
6. Business facilities and equipment catalog;
7. .Catalogue and text of business quality management system, work procedures and other documents;
8. Proof of authorization of the operator;
9. Other supporting materials.
The filing materials shall be complete, clear, printed and bound on A4 paper with a table of contents, and copies shall be stamped and submitted together with the electronic version. The window shall review the application materials, check whether the application materials are complete and complete, in accordance with the statutory form:
1: the application does not fall within the purview of the department according to law, it should immediately make a decision of inadmissibility, issue a special seal stamped with the date of the department "Notice of Inadmissibility", and inform the applicant to the relevant administrative organs;
2: the application materials There are errors that can be corrected on the spot, the applicant should be allowed to correct on the spot;
3: application materials are incomplete or do not meet the formal review requirements, the applicant should be issued on the spot, "Notice of Corrective Material", a one-time notification to the applicant of the need to make corrections to all the content;
4: the application materials are complete, in line with the requirements of the form of review, or the applicant in accordance with the requirements to submit all the corrective application materials, to be accepted. Supplementary application materials, to be accepted, issued with the department's special seal and date of the "Notice of Acceptance.