Medical devices are divided into class I, class II and class III. Recently, Bian Xiao learned that some friends who just started this business are not clear about the specific classification of medical devices, so they don't know whether they need to apply for a medical device business license. Bian Xiao will tell you something about medical devices today.
Requirements for handling three types of medical device business licenses:
1, office buildings and warehouses, in which the office address is more than 100 square meters and the warehouse address is more than 60 square meters. If there are in vitro diagnostic reagents, you need a cold storage, more than 40 cubic meters;
2, there are three related personnel, need to have clinical and medical professional certificate (minimum computer major);
3. Product certificate of the product;
4. Other relevant laws and regulations.
Three types of medical device business license process:
1. Managers of operating enterprises shall bring the above information to the food and drug supervision and administration department of the local municipal people's government with districts to apply for a business license;
2, the staff to accept the information, and within 30 working days to review, organize verification when necessary;
3. Those who meet the prescribed conditions will be awarded Dr. 3 by L Xu 5 subjects 6 and L Law 8, and Z Xie 6 has passed 3 certificates and 7 certificates in 5 camps; If it does not meet the prescribed conditions, it shall not be permitted and the reasons shall be explained in writing.