The Unique Device Identification (UDI) system is designed to improve the traceability and safety of medical devices. In Australia, the Therapeutic Goods Administration (TGA) is introducing UDI as part of its medical device regulatory reforms to align with international standards and enhance patient safety.

The UDI requirements in Australia align with two additional regulations that will require medical device manufacturers to enter their products (partially) into the respective databases by 2026: the EU database EUDAMED and the Swiss database Swissdamed. The AusUDID aims to ensure access to correct and complete datasets on medical devices and will also include the ability to view electronic package leaflets (Patient Information Leaflets, PILs). Entries in the AusUDID will also link to the corresponding entries in the Australian Register of Therapeutic Goods (ARTG).

Who Must Comply with UDI Requirements in Australia?

The UDI requirements apply to manufacturers of medical devices and so-called sponsors. They are responsible for entering the product master data into the AusUDID. Manufacturers located outside Australia require a local sponsor.

A sponsor under the TGA’s UDI regulations is a person or organisation based or registered in Australia that is legally responsible for complying with UDI requirements. This role is comparable to that of the Authorized Representative in the EU system. Responsibility for entering UDIs and the associated data lies with the sponsor, although they may delegate the task to the overseas manufacturer or a third party.

Manufacturers/sponsors have access to two systems for data entry:

• a test system to familiarise themselves with the AusUDID (Pre‑Production System), and
• the production system, which is publicly accessible and contains live data (Production Environment).

Main Components of the Australian UDI System

The TGA UDI framework consists of three main elements:

1. UDI-DI (Device Identifier)
   • A unique, fixed code identifying the device model.
2. UDI-PI (Production Identifier)
   • Variable information such as batch number, serial number, expiration date.
3. Australian UDI Database (AusUDID)
   • Central database for UDI data, similar to EUDAMED in the EU.

The issuing agencies recognised by the TGA for UDIs are:

• GS1
• Health Industry Business Communication Council (HIBCC)
• International Council of Commonality in Blood Banking Automation (ICCBBA)

Exemptions from UDI Requirements

The following products are exempt from mandatory UDI entry but may be entered voluntarily:

• Class I medical devices, non‑measuring, non‑sterile
• Class I medical devices, measuring (Im)
• In‑house IVDs
• Custom‑made medical devices
• Patient‑matched medical devices delivered in quantities of five or fewer per financial year
• Medical devices exempt under the Special Access Scheme (SAS) or Authorised Prescriber (AP) Scheme
• Surgical Loan Kits (SLKs) at kit level

Medical Devices

Class	Risk	Examples	UDI Required
Class I	Low	Face shield, tongue depressor, non-sterile gaze, incontinence pants, otoscope	No
Class Im (measurable)	Low-medium	Ora syringe, surgical drill guide, ECG recording paper	No
Class Is (sterile)	Low-medium	Surgical gown, sterile glove, medical drape, equipment, basic IV set	Yes
Class IIa	Low-medium	Digital or infrared thermometer, surgical glove, automated blood pressure cuff, suction tip	Yes
Class IIb	Medium-high	Hypodermic needle, surgical laser, lung ventilator, external defibrillator	Yes
Class III	High	Aortic heart valve, major joint replacement protheses, catheter guide wire, hernia mesh, absorbable sutures	Yes

In-vitro Diagnostics

Class	Risk	Examples	UDI Required
Class 1	No public health risk or low personal risk	Microbiological culture media, cleaning solutions, glucose meter	Partial (Erläuterung unten)
Class 2	Low public health risk or moderate personal risk	Pregnancy and fertility self-testing kits, test to detect rotavirus or adenovirus infections, cholesterol tests	Yes
Class 3	Moderate public health risk or high personal risk	Sexually transmitted disease test, e.g. herpes, chlamydia, HPV Human genetic test, e.g. Cytomegalovirus, Cystic Fibrosis, Cancer diagnostic test, Rapid antigen test for SARS-COV-2 virus	Yes
Class 4	High public health risk	Blood screening tests for HIV, syphilis test, Test for Ebola	Yes

Additionally, the following Class I IVDs must comply with UDI requirements:

• Instrument/analysis IVDs (Global Medical Device Nomenclature (GMDN) code 943)
• IVD software (GMDN 944)

Implementation Timeline for UDI Requirements in Australia

The TGA UDI framework is being introduced gradually. Since 2023, manufacturers/sponsors have been able to submit their data voluntarily.

The phased compliance schedule is based on risk classes. High‑risk products (Class III and AIMDs) are due in July 2026.

From 1 March 2025, the UDI must be included in all adverse event reports. It must also be recorded in patient records, discharge summaries, My Health Records (MHR), and on Patient Implant Cards (PICs).

All devices must be UDI-compliant by their specific deadlines. For high-risk products (Class III and IIb), additional UDI obligations may apply even if these products are already on the market before the deadline. Full implementation is expected by 2030.

Medical Devices

Requirement	Class III	Class IIb	Class IIa	Class Is
Placing UDI Carrier on the device lable	July 1, 2026	July 1, 2026	July 1, 2027	July 1, 2028
Submitting UDI-DIs and related data to the AusUDID	July 1, 2028	July 1, 2028	July 1, 2027	July 1, 2028
Direct markig of the IVD and supplying Direct Marking DI to the AusUDID	January 1, 2028	January 1, 2029 (N/A for implantable devices)	January 1, 2029	January 1, 2029

In-vitro Diagnostics

Requirement	Class 4	Class 3	Class 2	Class1
Placing UDI Carrier on the IVD label	July 1, 2028	July 1, 2028	July 1, 2029	July 1, 2029
Submitting UDI-DIs and related data to the AusUDID	July 1, 2028	July 1, 2028	July 1, 2029	July 1, 2029
Direct marking of the IVD and supplying Direct Marking DI to the AusUDID	July 1, 2029	July 1, 2029	July 1, 2030	July 1, 2030

Labelling Requirements

Manufacturers must:

• Place readable UDIs on the label.
• Use a machine-readable format (e.g., barcode or QR code).
• Ensure the UDI appears on the packaging and, where possible, directly on the device.

What Are the Benefits of a UDI System in Australia?

The introduction of the UDI system in Australia offers significant advantages for medical device manufacturers, sponsors, and healthcare institutions. Implementing the TGA UDI requirements greatly improves the traceability of medical devices, enabling faster and more efficient responses to recalls and safety notifications.

The central Australian UDI database (AusUDID) ensures transparent data management and facilitates integration into digital health systems. Mandatory device labelling with machine‑ and human‑readable UDI information enables clear identification throughout the entire product lifecycle.

The phased UDI compliance timeline provides manufacturers with planning certainty and supports harmonisation with international standards such as EU EUDAMED and US GUDID. Overall, UDI strengthens patient safety, optimises regulatory processes, and promotes global interoperability.