YY/T 1437-2023: Medical devices - Guidance on the application of GB/T 42062

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Scope

This document provides guidance on the development, implementation and
maintenance of a risk management system for medical devices according to GB/T
42062-2022.

Basic Data

Standard ID	YY/T 1437-2023 (YY/T1437-2023)
Description (Translated English)	Medical devices - Guidance on the application of GB/T 42062
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	77,781
Date of Issue	2023-06-20
Date of Implementation	2024-07-01
Older Standard (superseded by this standard)	YY/T 1437-2016
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies guidelines for developing, implementing and maintaining a medical device risk management system in accordance with GB/T 42062-2022. The risk management process can be an integral part of the quality management system (such as a system based on GB/T 42061-2022), but there is no such requirement in GB/T 42062-2022. Certain requirements related to risk management in GB/T 42061-2022 (Chapter 7 "Product Realization" and 8.2.1 "Feedback") can be achieved by applying GB/T 42062-2022, see YY/T 0595- 2020.