This document stipulates the basic data structure of the medical device supply chain management system that needs to meet regulatory requirements, including an overview of the medical device supply chain management system, overall system data requirements, regulated objects, medical devices, supply chain management processes, license management, automatic Monitoring requirements. This document is suitable for ensuring full traceability management of medical devices in the supply chain and meeting the regulatory requirements of the relevant regulatory authorities for medical devices.
T/CIITA 601-2022 history
2022T/CIITA 601-2022 Digital technology- Data- Basic data structure of supply chain management system for medical devices