The applicant should send the following application materials (documents, items) to the Municipal Administrative Service Center Market Supervision Bureau window:
1. "Class II Medical Device Business Record Form";
2. A copy of the business license;
3. A copy of the enterprise's legal representative or person in charge of the person in charge of the quality of the identity of the person in charge of the person in charge of the person's identity, education, title certificate;
4. Description of the organization and departmental settings;
5. Business address, warehouse address of the geographic location map, floor plan (indicating the actual use of the area), documents proving property rights or lease agreement (with documents proving property rights of the house) copy;
6. Business facilities and equipment directory;
7. Business quality management system
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 immediately made 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".