T/CIITA 601-2022 Active Group standards

T/CIITA 601-2022 Digital technology, data, and the basic data structure of a medical device supply chain management system

Publish Date: 2022-12-28 Implement Date: 2023-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CIITA 601-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated Information Technology (IT)

Publish Date: 2022-12-28

Implement Date: 2023-03-01

Scope

Scope: This document specifies the basic data structure that medical device supply chain management systems must meet to comply with regulatory requirements, including an overview of medical device supply chain management systems, overall system data requirements, regulated entities, medical devices, supply chain management processes, license management, and automatic monitoring requirements. This document applies to ensuring the full traceability of medical devices throughout the supply chain and meeting the regulatory requirements of relevant supervisory and management departments for medical devices. Main technical content: This document specifies the basic data structure that medical device supply chain management systems must meet to comply with regulatory requirements, including an overview of medical device supply chain management systems, overall system data requirements, regulated entities, medical devices, supply chain management processes, license management, and automatic monitoring requirements. This document applies to ensuring the full traceability of medical devices throughout the supply chain and meeting the regulatory requirements of relevant supervisory and management departments for medical devices.