AusUDID: Australia’s UDI Database Explained for Manufacturers

Where Australia stands

Australia’s UDI framework commenced on 27 March 2025, when the amendments to the Medical Device Regulations took effect. From that date, sponsors and manufacturers could comply voluntarily and submit UDI records to the AusUDID.

Mandatory compliance started on 1 July 2026 for the higher-risk classes: Class IIb and Class III medical devices must now meet the Australian UDI requirements, including the UDI on their labelling and the submission and publication of the required information in the AusUDID through a linked ARTG inclusion. The TGA describes a phased implementation over five years, by risk class: Class IIa devices follow on 1 July 2027, Class Is devices and Class 4 and 3 IVDs on 1 July 2028, and Class 2 and 1 IVDs on 1 July 2029. The obligations extend progressively until 30 June 2030, by which date all categories in scope will have entered the Australian UDI framework, subject to the applicable transitional or exemption arrangements.

Transitional arrangements exist for devices manufactured and labelled before their compliance date, and for devices supplied in Australia under an EU MDD or EU IVDD certificate. Not all devices qualify, and the TGA asks each sponsor to confirm the compliance date that applies to each device.

Two registers, one device: ARTG and AusUDID

A frequent shortcut is to treat AusUDID as the Australian EUDAMED. The Australian model actually rests on two distinct registers.

The Australian Register of Therapeutic Goods (ARTG) is the register of goods approved for supply in Australia. A device is “included” in the ARTG, and the sponsor holds that inclusion. The AusUDID stores UDI records: the UDI-DI and the related device data.

The two are linked, and the link is a condition of compliance. Each UDI record must point to the relevant ARTG inclusion or inclusions, and the TGA states that a record fully meets UDI requirements only when it is linked to a valid ARTG inclusion and published in accordance with the AusUDID rules. Several models supplied under a single ARTG inclusion each need their own UDI-DI, so several UDI records can point to the same inclusion.

The AusUDID is public. Patients, health professionals, clinical quality registries and the public can search a device by UDI-DI, brand name, ARTG number or GMDN term, view the history of a record, and download the full database daily, weekly or monthly, at no cost. The database does not store production identifiers (UDI-PI), patient information or commercially confidential information.

Manufacturer and sponsor: a shared responsibility

In Europe, the manufacturer is the actor who registers. In Australia, the TGA states that “sponsors and manufacturers share the responsibilities for meeting UDI requirements”.

The manufacturer chooses a TGA-recognised issuing agency (GS1, HIBCC or ICCBBA), allocates the identifiers (UDI-DI, UDI-PI and, where applicable, Unit of Use, Direct Marking and Package DIs), applies the UDI carrier on labels and packaging, and allocates a new UDI-DI when a change could lead to misidentification of the device.

The sponsor, the local entity that holds the ARTG inclusion, confirms that the manufacturer has met the UDI requirements, submits or completes the UDI record, and maintains it accurate and up to date. A sponsor may let a third party submit on its behalf, but remains responsible for the data submitted.

One obligation is explicitly shared: manufacturer and sponsor must agree between themselves who provides the device data and who submits the UDI record, and put that arrangement in place. For a foreign manufacturer working with several Australian distributors, that agreement is where the data governance question starts.

Several sponsors, one record

Australia’s regulatory model permits two or more sponsors to supply the same model of device, with the same UDI-DI. In that case, all sponsors link to the same UDI record: there is one record per UDI-DI, not one per sponsor.

To make this work, the AusUDID separates the data elements into two categories:

• device data elements, common to all sponsors because they are determined by the manufacturer (brand name, model, sterility, size, and so on);
• sponsor data elements, specific to each sponsor (ARTG ID, catalogue number) and editable only by that sponsor.

The first sponsor submits the record as normal. A subsequent sponsor only adds its own sponsor data and checks that the existing device data is accurate and complete; it does not duplicate the record. From then on, any change to a device data element on a shared record has to be recorded as a Correction, with a reason, and appears in the record’s History tab.

Responsibility follows the same logic: the sponsor that creates the initial record provides the starting data and establishes the first link with the ARTG. Each sponsor remains responsible for the accuracy of the information it adds, checks or modifies in the shared record. Changes are logged and attributed to their author. When a record is shared between several sponsors, the AusUDID allows several authorised organisations to contribute to its maintenance, and each change is traced in the record’s history with its justification.

For the manufacturer, the practical consequence is clear. The device data it has validated can then be maintained in a context involving several sponsors. Having a reference source and a mechanism to control changes becomes essential to keep the published data consistent across all markets.

Record states, grace period and UDI triggers

A UDI record moves through three states. A draft is visible only to the organisation that created it. A record published by a manufacturer is visible to logged-in users only, which lets the sponsor link its ARTG ID. Once a sponsor has published it, or linked its ARTG ID to it, the record becomes published and publicly available.

The first publication opens a 30-day grace period during which any data element can be edited. After that period, the rules change: a change to a UDI Trigger data element (brand name, model or version, device count, sterile packaging, single use, MRI safety status, clinical size, among others) requires a new UDI-DI and a new UDI record. Genuine errors in those fields can still be fixed through the corrections function, with a reason the TGA may review.

What will look familiar

Much of the Australian framework reuses what regulatory teams already know. The UDI-DI comes from the same issuing agencies as in Europe and the United States. The structure of the record, device data on one side and market-specific data on the other, follows the same logic as other UDI databases.

The submission channels are familiar too. The AusUDID accepts records one at a time through its portal, in batches of up to 200 through a bulk upload template, or through an automatic connection based on HL7 SPL. The TGA notes that this last method “aligns with the approach used by the United States Food and Drug Administration” for its own UDI database. Before any automatic submission to production, the TGA requires testing in its pre-production environment and a confirmation form; a third-party data provider can submit on a sponsor’s or manufacturer’s behalf, with credentials generated by that client.

Where the complexity appears

The difficulty is not AusUDID itself. It is a new variant of the same device data, held under rules that differ slightly for each active regulation:

• the same UDI-DI and device attributes now live in EUDAMED, GUDID, Swissdamed and AusUDID, each with its own data dictionary and update rules;
• in Australia, the record is held jointly by the sponsor, and sometimes by several sponsors, not by the manufacturer alone;
• after the 30-day grace period, a change that is routine in one database can require a new UDI-DI in another;
• the ARTG link has to be maintained as inclusions change;
• each automatic channel comes with its own testing cycle before production.

Handled market by market, this work is re-keyed several times, by different people, and the versions start to diverge. The divergence is rarely visible at the time; it surfaces during an audit, a recall, or when a distributor asks why the public record does not match the label.

How regulatory teams keep AusUDID consistent with the rest

The teams that manage this well do not start from the database. They start from one governed set of device data, validated once, from which each regulatory database is fed with the attributes it requires: the ARTG ID and sponsor data for Australia, the Basic UDI-DI for Europe, and so on.

ACKOMAS is built on that principle. The same central dataset serves EUDAMED, GUDID, Swissdamed and AusUDID. Each record is checked before anything leaves the platform, including by the built-in assistance features, which can analyse the data entered and flag potential inconsistencies or points that need further verification, stating the reason for the alert. Your team decides what to correct. Once validated, the data is published to each database, automatically where the authority provides a connection, and the platform keeps the proof of publication, the timestamps and the history of every change. The platform supports AusUDID publication alongside the other databases, so adding Australia to an existing portfolio is an extension of the same discipline, not a new project.

What manufacturers should remember

• Australia runs two registers: the ARTG for market authorisation and the AusUDID for UDI records. A record meets UDI requirements when it is linked to a valid ARTG inclusion and published in accordance with the AusUDID rules.
• Manufacturer and sponsor share the obligations and must agree who provides and who submits the data.
• A device sold by several sponsors can be associated with one shared UDI record. Actions on that record are logged, and the organisations involved have to maintain a common reference source to keep the regulatory data consistent.
• Compliance is phased: Class IIb and III since 1 July 2026, Class IIa from 1 July 2027, Class Is and Class 4 and 3 IVDs from 1 July 2028, Class 2 and 1 IVDs from 1 July 2029, and full compliance on 1 July 2030.
• The data model and the automatic channel reuse what already exists for GUDID and EUDAMED. What changes is one more place where the same data must stay true.

If you manage device data for Australia alongside other markets, structured governance is where it starts. Contact us, or explore the ACKOMAS solution.

Sources (TGA)

• Unique Device Identification (UDI) hub
• Sponsor and manufacturer obligations
• Managing UDI records with multiple sponsors
• AusUDID concepts
• AusUDID submission methods
• Complying with the Unique Device Identification timeframes for medical devices
• New UDI requirements for medical devices commence 1 July 2026