Medical device license change to meet the following requirements:
1, the provincial administrative region has obtained the "medical device business license" business enterprises;
2, in line with the "Medical Device Business License Management Measures" and "Provincial start-up of medical equipment business acceptance of the implementation of the standards (revised in 2007)" requirements. Application for change of enterprise name, legal representative, enterprise responsible person, quality manager, registered address, warehouse address, business scope of the relevant provisions.
Medical device license change processing time
30 working days (15 working days without on-site survey)
Monday to Friday 8:30 a.m.-12:00 p.m., 14:00 p.m.-17:30 p.m. (except for legal holidays)
Changing the medical device license what information is required:
< p>1, a copy of the business license;2, the legal representative, the person in charge of the enterprise, the person in charge of quality of the identity card, a copy of the certificate of academic qualifications or titles;
3, organization and departmental setup description;
4, the scope of business, the business mode of description;
5, the business premises, warehouse address of the geographic location of the map, the floor plan, Housing ownership documents or lease agreement (with housing ownership documents) copies;
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, basic information on computer information management system and functional description;
9, proof of authorization by the operator;
10, other supporting materials
Medical device business license is not just any change, even the relevant quality management personnel responsible for the same, are required to file, submit material proof, warehouse and business premises and legal person, not to mention.