According to the "Supervision and Administration of Medical Devices Business", engaged in the operation of medical devices, should have the following conditions:
(a) with the scale and scope of operation of the business premises;
(b) with the scale and scope of operation of the equipment, storage facilities and sanitation;
(c) with the scale and scope of operation of the quality management body or quality management personnel;
(d) with the scale and scope of operation of the business premises;
(e) with the scale and scope of operation of the business premises. Business scale and scope of operation of the quality management organization or quality management personnel;
(d) with the scale and scope of operation of the quality management system;
(e) the state food and drug administration and management of other conditions.
Medical device business enterprises should meet the above conditions, and according to law to obtain a medical device production license, business license or for the record.