Do the second class medical device license what conditions are required

One, with the scale and scope of operation of the quality management organization or full-time quality management personnel.

Quality management personnel should have a nationally recognized professional qualifications or titles;

Second, with the scale and scope of operation of relatively independent premises;

Third, with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;

Fourth, product quality should be established and improved Management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;

V. Should have the appropriate technical training and after-sales service capacity of its medical device products, or agreed by the third party to provide technical support.

Legal basis

"Medical Device Business License Management Measures" Article VI

Application for "Medical Device Business License" shall have the following conditions:

(a) with the scale and scope of operation of the quality management organization or full-time quality management personnel.

Quality management personnel should have a nationally recognized professional qualifications or titles;

(b) with the scale and scope of operation of relatively independent premises;

(c) with the scale and scope of operation of the storage conditions, including the characteristics of medical devices with the requirements of the storage facilities, equipment;

(d) should establish and improve the quality of product management system, including purchasing and sales of medical devices. Product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;

(v) should have its business with the medical device products appropriate technical training and after-sales service capabilities, or agreed by the third party to provide technical support.