The necessary conditions to obtain the approval of the department:
Should
1: the person in charge of the enterprise should have a secondary school education or above, or junior title, and understanding of the supervision and management of medical devices related to the statutes and regulations;
2: the quality management organization or quality management personnel with the scope of business and the scale of operation appropriate, the quality management organization or full-time quality management personnel should have with the proposed medical device products. Business scale appropriate quality management organization or quality management personnel, quality management organization or full-time quality management personnel should have and to operate the medical device products related to professional secondary school education or above junior title;
3: with business scope and business scale appropriate business, storage space; for medical equipment business space area of not less than 20 square meters; warehousing 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 residential housing; retail chain enterprises should be set up in accordance with the scale of the headquarters of the warehouse, with 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 the storage of other medical equipment business enterprises can not set up a warehouse;
5: with the operation of medical devices appropriate quality management system;
6: with the operation of 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 Credentials.
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 of the legal representative or person in charge of the enterprise or the person in charge of the quality, academic qualifications, 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. . enterprise business quality management system, work procedures and other documents catalog and text;
8. Proof of authorization of the operator;
9. other supporting materials. The filing materials should be complete, clear, printed and bound on A4 paper with a table of contents, and the copies should be stamped and submitted together with the electronic version.
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 by law, it should be made immediately inadmissible decisions, issued with the department's special seal and date of the "inadmissibility of notification", and inform the applicant to the relevant administrative organs;
2: application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
3: application materials are incomplete or do not meet the requirements of the formal review, the applicant should be issued on the spot to the "Notice of Corrective Material", a one-time notification to the applicant needs to make corrections to all the content;
4: the application materials are complete, in line with the requirements of the form of the review, or the applicant Submitted in accordance with the requirements of all corrective application materials, be accepted, issued with the department's special seal and date of the "Notice of Acceptance".