1. Among the quality management personnel engaged in in in-vitro diagnostic reagents, 1 should be the competent inspection personnel, or have a college degree or above in inspection and have been engaged in inspection-related work for more than 3 years. Personnel engaged in the acceptance and after-sales service of in vitro diagnostic reagents shall have a technical secondary school degree or above in laboratory science or a junior professional title or above in laboratory science;
2, operating in vitro diagnostic reagent wholesale enterprises, business premises use area of not less than100 ㎡; Set up a warehouse that meets the storage requirements of diagnostic reagents, with an area of not less than 60 square meters (excluding cold storage) and a capacity of not less than 20m? ;
3. Office software for medical equipment;
4. Materials:
(1) A copy of the property right certificate of the business place (including warehouse+cold storage) and the original lease contract;
(2) A copy of the cold storage qualification is stamped with the red seal of the right holder;
(3) The supplier's medical device registration certificate, copy of business license and power of attorney (stamped with the supplier's red seal).
(2) Processing cycle
1. It takes about 60 working days to register a company and apply for a license.