"Supervision and management of medical devices business" Chapter II, Article 7, engaged in the operation of medical devices, should have the following conditions:
(a) 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 nationally recognized professional qualifications or titles;
(b) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have nationally recognized professional qualifications or titles;
(b) with the (B) with the scope of business and scale of operation of the business, storage space;
(C) with the scope of business and scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(D) with the operation of the medical device quality management system;
(E) with the operation of the medical device Compatible with the ability of professional guidance, technical training and after-sales service, or agreed to provide technical support by the relevant organizations.
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 requirements of medical device business quality management.