1, with the scale and scope of operation of the quality management organization or full-time quality management personnel.
Quality management personnel should have state-recognized professional qualifications or titles;
2, with the scale and scope of operation of relatively independent premises;
3, with the scale and scope of operation of the storage conditions, including the requirements of the characteristics of the medical device product storage facilities, equipment;
4, 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;
5, 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.
Legal basis: "Supervision and Management of Medical Devices Regulations," Article 21
Registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, the use of substantial changes that are likely to affect the safety of the medical device, effective, the registrant shall apply for registration procedures for change; occurring in the original registered department Apply for a change in registration procedures; other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.