T/GXDSL 059-2026 Active Group standards

T/GXDSL 059-2026 Specification for Monitoring and Reporting of Medical Device Adverse Events in Healthcare Institutions

Publish Date: 2026-03-13 Implement Date: 2026-03-13 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/GXDSL 059-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Urban transportation facilities

ICS Name: Other standards related to the organization and management of companies (enterprises)

Publish Date: 2026-03-13

Implement Date: 2026-03-13

Scope

This standard specifies the technical requirements, management norms, and operational procedures for the monitoring and reporting of adverse events of medical devices in medical institutions, covering the entire process of management from event identification to subsequent improvement. This standard applies to the monitoring and reporting of adverse events of medical devices conducted by all levels and types of medical institutions, including general hospitals, specialized hospitals, community health service centers, township hospitals, outpatient departments, clinics, and other medical and health institutions at all levels and types