DB32/T 4553-2023 Guidelines for Monitoring of Adverse Events of Medical Devices in Healthcare Institutions

Scope

This document stipulates the general principles, institutional setup, staffing and responsibilities, work systems and procedures for medical institutions to carry out adverse event monitoring of medical devices.
This document is applicable to secondary and above-level medical institutions in carrying out adverse event monitoring of medical devices. Other medical institutions may refer to and implement it when conducting adverse event monitoring of medical devices.

Development Information

Related Standards