Inner Mongolia Class II medical device filing conditions

According to the query Inner Mongolia government services network shows that the following is the filing conditions of the second class of medical devices in Inner Mongolia:

1, with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a state-recognized relevant professional qualifications or titles;

2, with the scope of business and the scale of operation of the operation of the appropriate, Storage place;

3, with the scope of business and business scale of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;

4, with the operation of the medical device quality management system;

5, with the operation of the medical device appropriate professional guidance, technical training and after-sales service capacity

6, or agreed by the relevant organizations to provide technical support.

Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a computerized information management system in line with the quality management requirements of medical device business.