Class II is cheaper, Class III is about 100,000
Medical devices are divided into a class, Class II, Class III, recently I learned that some just engaged in this line of friends are not quite clear about the specific classification of medical devices, so it is not clear whether they need to apply for a medical device license, today I will tell you about the Medical equipment related knowledge it.
Requirements for a Class III medical device license:
1, office space and warehouse, where the office address is greater than 100 square meters, the warehouse address is greater than 60 square meters, if there is an in vitro diagnostic reagent needs to have a cold storage, and is greater than 40 cubic meters;
2, there are three relevant personnel, need to have Clinical, medical professional certificates (minimum requirements of computer science);
3, there are product certificates of the products operated;
4, other relevant legal and regulatory requirements.
Three types of medical equipment business license process:
1, business enterprise operator with the above information to the location of the municipal people's government food and drug supervision and management department to apply for a license;
2, the staff accepts the information and review within 30 working days, if necessary, the organization of the Verification;
3, to meet the prescribed conditions, grant l permit 5 can 6 and l 8 issued to the medical 3 therapeutic equipment Z mechanical 6 operating 5 7 license 3 certificate; do not meet the prescribed conditions, do not permit and explain the reasons in writing.