Since the past few years, the United States Food and Drug Administration (FDA), the European Commission (EC), and other regulatory agencies have made patient safety a priority by developing UDI regulations for MD and IVD. These regulatory bodies are aiming for a globally harmonized and consistent approach aligned with the IMDRF guidelines. The Unique Device Identification (UDI) System is a system meant to identify a specific medical device by providing a unique numeric or alphanumeric code to the device model and production identifier. This allows for the clear identification of specific devices on the market and facilitates their traceability. There are generally two (2) main parts to a UDI: the device identifier (DI) and the production identifier (PI).

 

The device identifier is a mandatory, fixed portion of a UDI that identifies the labeler (often the manufacturer) and the specific version or model of a device. The product identifier, on the other hand, is a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:

• ● Lot or batch number of the device
• ● Serial number of a specific device
• ● Expiration date of a specific device
• ● Date a specific device was manufactured
• ● Distinct identification code for a human cell, tissue, or cellular and tissue-based product (HCT/P)
•  

During the process of implementation, the labeler (usually the manufacturer) must first work with the regulatory agencies and upload the proposed UDI to the agency database to create a master data source. When implemented, the label add-on pasted on the medical devices must include a UDI in both human-readable and machine-readable form.

 

The main incentive for manufacturers to implement the UDI system is the faster traceability of medical devices. In parallel to this, the post-market safety-related activities for devices will also be more standard and robust, providing better monitoring by the competent authorities. Another use of the UDI system is for better identification of falsified devices and a quicker recall response in the event of errors. This system is also expected to improve buying and waste disposal policies, alongside the stock-management strategy, by health institutions and other economic operators.

 

To avoid confusion, regulatory agencies only allow a limited number of UDI systems on their territory. As of this writing, the US FDA only allows three (3) UDI issuing agencies (GS1, HIBCC, and ICCBA), while the EC allows four (4) UDI issuing agencies (GS1, HIBCC, ICCBBA, and IFA). The GS1 issuing agency is the most widely used supply chain standards system in the world. The HIBCC is the primary standard-setting and educational organization for healthcare bar-coding in the United States. The ICCBBA is usually for the coding and labeling of Medical Products of Human Origin (MPHO) that are regulated as medical devices or medical devices containing an MPHO component. Lastly, the IFA GmbH is an issuing entity for UDI-DI set by the Commission Implementing Decision of the EU.

 

The table below highlights the UDI implementation dates of the territories serviced by Qualtech:

Country	Implementation dates				More Info
Australia	Compliance date has been deferred to a later date due to government bills and budget measures.				TGA QT News
China	First batch of devices			1 January 2021	NMPA (ENG) NMPA (CN)
	Second batch of devices			1 June 2022
	Third batch of devices			TBA
European Union (EU)	Submission of data to database	26 Nov 2022			EC EC (FAQ)
	Class I	26 May 2025
	Class IIa and IIb	26 May 2023
	Class III and implants	26 May 2021
	Legacy devices	26 May 2024 (at the latest), but data submission deadline still applies
Hong Kong	Not yet implemented/Still in progress
Indonesia	Not yet implemented/Still in progress
Japan	1 Dec 2022				PMDA (JP) GS1 (JP)
Malaysia	Not yet implemented/Still in progress
Philippines	Not yet implemented/Still in progress
Singapore	Class A		Voluntary basis – no mandatory requirement		HSA QT News
	Class B		1 Nov 2028
	Class C		1 Nov 2026
	Class D		1 Nov 2024
	High risk implantable MDs (e.g., stents)		1 Nov 2022
South Korea	1 July 2022				GS1 (ENG) MFDS (KOR)
Taiwan	Class II			1 June 2023	TFDA (ENG) TFDA (CN)
	Class III (Non-implant)			1 June 2022
	Class III (Implant)			1 June 2021
Thailand	Not yet implemented/Still in progress
United States (US)	September 24, 2020 (all unexempted devices must bear UDI as a permanent marking on the device itself)				FDA
Vietnam	Not yet implemented/Still in progress

 

References:

• ● US FDA: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
• ● EC: https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en
• ● TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub
• ● China (English): http://english.nmpa.gov.cn/2022-06/30/c_785636.htm
• ● China (Chinese): https://udi.nmpa.gov.cn/home.html
• ● Japan (PMDA): https://www.pmda.go.jp/files/000246918.pdf
• ● Japan (GS1):  https://www.gs1jp.org/standard/healthcare/tenbunnavi/#:~:text=%E8%80%85%E3%81%AE%E6%96%B9-,%E3%83%90%E3%83%BC%E3%82%B3%E3%83%BC%E3%83%89%E8%A1%A8%E7%A4%BA%E3%81%AE%E7%BE%A9%E5%8B%99%E5%8C%96,%E3%81%95%E3%82%8C%E3%82%8B%E3%81%93%E3%81%A8%E3%81%A8%E3%81%AA%E3%82%8A%E3%81%BE%E3%81%99%E3%80%82
• ● Singapore: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/guidance-on-medical-device-udi-system-(27aug_pub).pdf
• ● Korea (GS1): https://www.gs1.org/sites/default/files/docs/healthcare/2018.%20Conference%20Bangkok/BKK-Presentation-Day3/02.Day3_Plenary_BG-Kim_The-New-Regulation-on-UDI-in-KOREA.pdf
• ● Korea (Korean): https://udiportal.mfds.go.kr/contents/MNU10024
• ● Taiwan (English): https://www.fda.gov.tw/ENG/newsContent.aspx?id=28380
• ● Taiwan (Chinese): https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637897763887569364&type=2&cid=40662
• ● GS1: https://www.gs1.org/industries/healthcare/udi
• ● HIBCC : https://www.hibcc.org/udi-labeling-standards/
• ● ICCBBA: https://www.isbt128.org/technical-documents

● IFA: https://www.ifaffm.de/en/ifa-codingsystem.html