YY/T 1943-2024 English PDF (YYT1943-2024)

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YY/T 1943-2024: UDI implementation and application in medical device package levels
YY/T 1943-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.040
CCS C 30
UDI implementation and application in medical device
package levels
ISSUED ON. JULY 8, 2024
IMPLEMENTED ON. JULY 20, 2025
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 5
2 Normative references... 5
3 Terms, definitions and abbreviations... 5
4 General rules... 6
5 Implementation of UDI packaging... 6
6 Analysis of each product packaging level in the supply chain... 9
Appendix A (Informative) Examples of product packaging levels and shipping
containers... 11
Appendix B (Informative) Conversion and analysis of multiple packaging levels when
the minimum sales unit contains 1 unit of use... 12
Appendix C (Informative) Conversion and analysis of the minimum sales unit and the
unit of use... 13
Appendix D (Informative) Example of recording product consumption without a UDI
data carrier for the unit-of-use... 14
References... 15
UDI implementation and application in medical device
package levels
1 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.
2 Normative references
The contents of the following documents constitute the essential clauses of this
document through normative references in this text. Among them, for referenced
documents with dates, only the versions corresponding to the dates are applicable to
this document; for referenced documents without dates, the latest versions (including
all amendments) are applicable to this document.
YY/T 1681 Basic terms of unique device identification system
YY/T 1752 Basic data set of unique device identification database
YY/T 1753 Reporting guide of unique device identification database
YY/T 1942 Form and content of the unique device identifier
3 Terms, definitions and abbreviations
3.1 Terms and definitions
The terms and definitions defined in YY/T 1681 apply to this document.
3.2 Abbreviations
The following abbreviations apply to this document.
AIDC. automatic identification and data capture
HRI. human readable information
UDI. unique device identifier
UDID. unique device identification database
UDI-DI. device identifier
UDI-PI. production identifier
UoU UDI-DI. unit of use device identifier
4 General rules
4.1 The packaging in this document refers to the product packaging level where the
products contained therein have the same minimum sales unit UDI-DI and production
batch number.
NOTE. A product packaging level contains a fixed number of medical devices.
4.2 Product packaging levels do not include shipping containers. Examples of product
packaging levels and shipping containers are shown in Appendix A.
NOTE. From a traceability perspective, the shipping container itself is traceable in the logistics system
without the need for UDI.
4.3 The composition of UDI-PI for different packaging levels of medical devices of the
same specification and model should be consistent.
4.4 New packaging configurations shall be assigned a new UDI-DI.
4.5 When a product has multiple product packaging levels, a packaging identifier (if
applicable) should be used to distinguish different levels of packaging. The compilation
of the packaging identifier shall comply with the rules of the coding agency.
5 Implementation of UDI packaging
5.1 The minimum sales unit contains 1 unit of use
When the minimum sales unit of a medical device contains 1 unit of use and the higher-
level packaging has only a unique packaging quantity form, the minimum sales unit of
the medical device and the higher-level packaging should be assigned UDI-DI and
given a unique identifier data carrier. In UDID, the information corresponding to the
minimum sales unit shall be uploaded to UDID and linked to the highest level of
packaging layer by layer in accordance with the requirements of YY/T 1752 and YY/T
1753.The different product packaging levels with a single packaging quantity and their
association in the UDID are shown in Table 1.
the minimum sales unit in accordance with the relevant requirements of YY/T
1942;
d) The UDI information recorded in the information systems of all parties in the
supply chain shall be consistent with the product UDI;
e) Since UDIs of different product packaging levels may be scanned during
warehousing and consumption, the warehousing, consumption, and inventory
quantities shall be balanced after conversion;
f) Establish records containing UDI information in accordance with laws,
regulations and related document requirements to ensure traceability.
Examples of conversion and analysis of packaging in this case are given in Appendix
B.
6.2 The minimum sales unit contains multiple units of use
When management at the unit-of-use level is required, the analysis of each level of UDI
packaging is based on 6.1, and usually the following shall also be considered.
a) Establish the quantity conversion relationship between the unit-of-use of a
medical device and the minimum sales unit in the information systems of all
parties in the supply chain;
b) After the minimum sales unit of a medical device is opened and becomes the
unit-of-use of a medical device, the quantity of the unit-of-use is obtained
according to the conversion relationship, and the unit conversion is performed,
see Appendix C;
c) When the unit-of-use of a medical device is consumed, the UDI-PI of its
corresponding minimum sales unit shall be recorded;
d) In the case of a unit-of-use without a UDI data carrier, the consumption of the
unit-of-use shall be recorded by appropriate means. Appendix D provides one
of the methods, the incoming, consumed and inventory quantities shall be
balanced after conversion.
NOTE. For situations where a manufacturer proactively assigns a UDI data carrier to a unit-of-use to
meet the application requirements of medical institutions, refer to the requirements of 6.1.