What materials are required to apply for Class III medical device licenses?
Release time:
2024-08-30
Materials required for handling Class III medical devices
Materials required for handling Class III medical devices
1、 Original business license and official seal
2、 Copy and original of the legal representative's ID card and graduation certificate
3、 Copy of property ownership certificate and contract for office and warehouse (the contract should correspond to the property owner). 4. Copy of ID card and telephone number for the legal representative, person in charge, sales, and procurement (the person in charge can be the same person as the legal representative). All personnel must undergo a physical examination (in a second-class or above hospital). 5. Business scope of medical equipment:
6、 The product registration certificate and supplier qualifications operated. (Supplier qualification requires official seal) 7. Original graduation certificate of quality administrator (with at least 3 years of relevant medical college degree or above) and telephone number, and physical examination (from a second-class hospital or above) 8. Medical device procurement, sales, and storage software (must be software recognized by the Food and Drug Administration)
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