YY/T 1960-2025: Medical devices - Information to be supplied by the manufacturer

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Scope

This document specifies the requirements for information to be supplied by the
manufacturer of medical devices or accessories. This document includes generally
applicable requirements for the marking and labeling of medical devices or accessories
on their own and their packaging, as well as the identification and accompanying
information of medical devices or accessories. This document does not specify the
method of providing information.
The requirements of medical device product standards or group standards take
precedence over the requirements of this document.
Note 1.See Annex A, A.2 for the guidelines or instructions for this clause.
Note 2.The requirements for the labeling, marking, and accompanying
documentation of medical devices or accessories - as imposed by certain
regulatory authorities with jurisdiction - may differ from those in this
document.

Basic Data

Standard ID	YY/T 1960-2025 (YY/T1960-2025)
Description (Translated English)	Medical devices - Information to be supplied by the manufacturer
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	38,396
Date of Issue	2025-06-18
Date of Implementation	2026-07-01
Issuing agency(ies)	National Medical Products Administration
Summary	This standard specifies the requirements for information provided by manufacturers of medical devices or accessories. This document includes the generally applicable requirements for markings and labels on the medical device or accessory itself and its packaging, the labeling of the medical device or accessory, and accompanying information. This document does not specify the method of providing information. The requirements of medical device product standards or professional standards take precedence over those of this document.