What system does the state implement according to the product category distribution of medical devices to realize the traceability of medical devices?

Legal analysis: a unique identification system. The newly revised "Regulations" put forward that the state should gradually implement the unique identification system of medical devices according to the product categories of medical devices to realize the traceability of medical devices.

Legal basis: Article 35 of the Regulations on the Supervision and Administration of Medical Devices, medical device registrants, filers and entrusted production enterprises shall establish and improve the quality management system suitable for the medical devices produced in accordance with the quality management standards for medical device production, and ensure their effective operation; Organize production in strict accordance with the technical requirements of registered or filed products, and ensure that the medical devices delivered from the factory meet the mandatory standards and the technical requirements of registered or filed products.

Medical device registrants, filers and entrusted production enterprises shall regularly conduct self-inspection on the operation of the quality management system, and submit self-inspection reports in accordance with the provisions of the drug supervision and administration department of the State Council.