(a) with the scale and scope of operation of the quality management organization or quality management personnel to adapt to two. Quality management personnel should have a nationally recognized professional qualifications or titles, quality management should be on duty, not in other units part-time;
(b) with the scale and scope of operation of the relatively independent premises;
(c) with the scale and scope of operation of the storage conditions, including with the characteristics of medical equipment product requirements
(d) should establish and improve 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 its business with the medical device products appropriate technical training and after-sales service capabilities.
(F) with the operation of medical devices with appropriate quality management system.