The following application materials are required for a medical device license:
1.? Resident identity card
2.? Copy of certificate of education or title
3.? Application Form for Medical Device License
4.? Organizational structure and departmental setup description?
5. Description of the scope of business, business mode
6. Business facilities, equipment catalog
7. Business quality management system, work procedures and other documents catalog
8. Basic information and functional description of the computer information management system
9. Authorization letter
10.? Business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights)?
11. Business license
Medical equipment business license process is as follows:
Medical equipment business license