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:


Implementation dates

More Info


Compliance date has been deferred to a later date due to government bills and budget measures.


QT News


First batch of devices

1 January 2021



Second batch of devices

1 June 2022

Third batch of devices


European Union (EU)

Submission of data to database

26 Nov 2022



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


Not yet implemented/Still in progress


1 Dec 2022


GS1 (JP)


Not yet implemented/Still in progress


Not yet implemented/Still in progress


Class A

Voluntary basis – no mandatory requirement


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




Class II

1 June 2023



Class III (Non-implant)

1 June 2022

Class III (Implant)

1 June 2021


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)



Not yet implemented/Still in progress



● IFA: