What materials are required to apply for a Class III medical device license?

Materials required for handling Class III medical devices
1. Original business license and official seal
2. Copy and original of ID card and graduation certificate of legal representative
3, copy of the title certificate and office, warehouse contract (the contract should be corresponding to the property owner).
4. A copy of the ID card and telephone number of 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 medical examination (at a level 2 or higher hospital).
5, medical equipment business scope:
6, product registration certificate and supplier qualification certificate. (Supplier qualification shall be stamped with official seal)

7. The original graduation certificate of the quality administrator (at least 3 years of relevant medical college degree) and telephone number, and 8 copies of physical examination (secondary hospital or above). Medical device procurement, sales and storage software (must be FDA approved software)