(1) Having two quality management institutions or quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state, and they should be on-the-job and not part-time in other units;

(2) Having a relatively independent business place suitable for its business scale and business scope;

(3) Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;

(four) establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound audit, quality tracking system and adverse event reporting system;

(5) Having the ability of technical training and after-sales service suitable for the medical device products it deals in.

(6) Having a quality management system suitable for the medical devices it deals in.