For personal business license Class II medical device record what materials are needed

The registration of Class II medical devices is to the municipal bureau, find your city Food and Drug Administration to see the guide, because each city has differences, but basically similar, I give you here in Shenzhen for the registration of Class II medical devices process.

Note: Before submitting a written declaration, the Shenzhen Food and Drug Administration should be submitted through the Shenzhen Food and Drug Administration comprehensive business application system online administrative license application. Enterprises in the submission of paper application materials must be submitted at the same time the pre-acceptance number.

I. Information requirements

The following materials need to be scanned and uploaded in the collaborative supervision of the electronic platform, copies need to be stamped or signed by the legal representative or person in charge of the enterprise. 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 online application.

1. Class II medical device business filing form;

2. A copy of the business license and organization code certificate;

3. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of a copy of the certificate of qualifications or titles;

4. Organizational and departmental setup description;

5. Scope of business, business methods Description;

6. Business premises, warehouse address geographic location map, floor plan, documents proving ownership of the house or a copy of the lease certificate issued by the housing lease;

7. Business facilities, equipment directory;

8. Business quality management system, work procedures and other documents directory;

9. Proof of authorization by the operator.

Second, the processing time limit: on the spot for the record

Third, the record department: Shenzhen Food and Drug Administration