Medical device companies registered in Shanghai, for the record of Class II medical devices to prepare what materials? The process is how? A together to understand.
One, the material requirements
The following materials need to be scanned and uploaded in the collaborative supervision 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 time limit: on the spot for the record
Third, the record department: Shanghai Food and Drug Administration