1, with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have nationally recognized professional qualifications or titles.
2, with the scale and scope of operation of relatively independent business premises.
3, with the scale and scope of operation of the storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical devices.
4, 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.
5, should have the appropriate technical training and after-sales service capacity of its medical device products, or agreed to provide technical support by a third party.