Help: I saw on the Internet GSP is for drugs, our company is operating in the centralized purchasing and distribution of medical equipment, may I apply for GSP certification?

Individual operation of medical devices do not need GSP certification, as long as there is a "Medical Device Business License", "Business License", and in accordance with the "Medical Device Business License Management Measures", "Medical Devices Supervision and Administration Regulations" business can be.

Drug supervision and management departments in accordance with the provisions of the medical device business enterprises whether to meet the requirements of the "quality management standard for the operation of medical devices" certification; qualified certification, issued by the certificate of authentication.

The conditions for operating medical devices:

(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 relevant 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 appropriate storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;

(D) should be (D) should establish and improve the 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;

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