YY/T 1943-2024: UDI implementation and application in medical device package levels

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Scope

This document specifies the implementation of unique identification of packaging at
each product packaging level for medical devices and its analysis in the supply chain.
This document applies to the implementation and application of unique device
identifiers of multi-level packaging medical device products.

Basic Data

Standard ID	YY/T 1943-2024 (YY/T1943-2024)
Description (Translated English)	UDI implementation and application in medical device package levels
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040
Word Count Estimation	18,192
Date of Issue	2024-07-08
Date of Implementation	2025-07-20
Drafting Organization	Medical Device Standard Management Center of the State Food and Drug Administration, General Hospital of the Chinese People's Liberation Army, General Electric Medical Systems Trading Development (Shanghai) Co., Ltd., China Medical Device Co., Ltd., Peking University Third Hospital, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shandong Medical Device and Drug Packaging Inspection Institute, Shanghai Pharmaceuticals Medical Device (Shanghai) Co., Ltd., Weihai Weibo Medical Technology Co., Ltd.
Administrative Organization	Medical Device Standard Management Center of the State Drug Administration
Proposing organization	State Drug Administration
Issuing agency(ies)	State Drug Administration