Understanding and efficiently implementing UDI requirements in Australia
With the Australian UDI Database (AusUDID), Australia operates its own system for the unique identification of medical devices. Depending on the product class, the obligations for UDI labelling and data submission will apply gradually from 2026 onwards.
Basics
What is the AusUDID?
The Australian UDI Database (AusUDID) is the central Australian database for the unique identification of medical devices supplied in Australia.
The purpose of the AusUDID is to improve the traceability of medical devices in the Australian market, strengthen patient safety, and support regulatory measures such as recalls or field safety corrective actions more efficiently.
The database is explicitly not designed for general inventory management, but for regulatory unique identification and traceability.
Each UDI record remains permanently in the database. Changes are versioned, so it is possible to trace at any time which product data was valid and when. A record becomes publicly visible once it is linked to an ARTG inclusion.
Stored data
UDI-DI, product class, GMDN code, manufacturer details, sponsor data, and commercial distribution status.
Not included in the UDI record
The UDI-PI (Production Identifier) is deliberately not part of the AusUDID dataset.
Long-term maintenance
Records remain permanently available and are versioned. Changes are transparently traceable at any time.
Public visibility
A record becomes public once it is linked to an ARTG inclusion.
Obligations
Who is affected?
The TGA clearly distinguishes between the obligations of manufacturers and Australian sponsors. Both carry responsibility – different, but complementary.
Manufacturer Obligations
- Selection of an issuing agency recognised by the TGA (e.g. GS1, HIBC)
- Assignment of UDI-DI and UDI-PI in accordance with TGA requirements
- Technical implementation of UDI labelling on the device and packaging
- Preparation of device data for submission to the AusUDID
- Coordination with the Australian sponsor regarding submission processes
Sponsor Obligations
- Ensuring that UDI requirements have been fulfilled by the manufacturer
- Responsibility for correct and up-to-date UDI records in the AusUDID
- Coordination of data submission with the manufacturer
- Supplementing existing manufacturer records with sponsor-specific data
- Submission of UDI data within the statutory deadlines
Deadlines
UDI implementation timeline
Implementation is risk-based and phased by class. Plan early – especially for Class III and IIb, only a few months remain until July 2026.
| Medical Devices | IVDs |
|
1 July 2026
Class IIIClass IIb
UDI labelling and data submission to the AusUDID become mandatory. The highest risk classes are the first phase of implementation. 1 July 2027
Class IIa
Medium risk, second phase. Manufacturers and sponsors of this class must have established all UDI processes by this date. 1 July 2028
Class Is
Lowest risk class for medical devices. Completion of the phased MD implementation. |
1 July 2028
IVD Class 4IVD Class 3
High-risk classes in the IVD sector start first. Data submission and labelling must be fully fulfilled from this date. 1 July 2029
IVD Class 2IVD Class 1
Lower-risk classes follow one year later. This completes the full UDI implementation for Australia. |
30-day rule: UDI data must generally be submitted to the AusUDID within 30 days after the next supply of the device in Australia. For Class III and IIb devices that were manufactured and labelled before 1 July 2026 but are still within the sponsor’s control on or after 1 July 2029, a relabelling obligation also applies.
Labelling
Accepted identifiers
The TGA requires the UDI-DI to come from a recognised issuing agency.
GS1 GTIN |
HIBC-UPN |
ICCBBA ISBT 128 PPIC |
| Global Trade Item Number – the most widely used UDI carrier, ideal for globally distributed products with existing GS1 infrastructure. | Health Industry Business Communications – particularly established in the US and clinical environments. Recognised by the TGA. | Specifically for blood products and cellular therapies. A niche standard with clear regulatory recognition by the TGA. |
Important for international manufacturers: Australia accepts UDI carriers aligned with EU or US requirements – provided that the UDI-DI used comes from a TGA-recognised issuing agency. In many cases, complete relabelling is not necessary.
Data submission
How is UDI data submitted?
The TGA provides four different submission pathways – from manual to fully automated. The right choice depends on data volume and technical infrastructure.
Online PortalManual entry of individual UDI records directly in the TGA portal. Suitable for small product portfolios or initial testing. Individual records |
Excel Bulk Upload TemplateStandardised TGA Excel template for up to 200 records per upload. Efficient for medium data volumes without technical infrastructure. Up to 200 records |
M2M via HL7 SPLMachine-to-machine connection via HL7 Structured Product Labeling. The TGA recommends this pathway for large volumes. Pre-production validation is mandatory before productive use. Recommended for large volumes |
Frequently Asked Questions
Answers to the questions that arise most frequently in practice.
Does each ARTG inclusion have to be linked separately to a UDI record?
Yes, linking to the ARTG inclusion is necessary to make a UDI record publicly visible and to fulfil the regulatory requirement. The TGA is clear on this: sponsors and manufacturers must ensure that the assignments are correct.
Can a manufacturer prepare the device data and the sponsor supplement the sponsor data?
Yes, this is the recommended approach. Manufacturers and sponsors can split the tasks: the manufacturer prepares the device data, and the sponsor adds its sponsor-specific information. If another sponsor has already created a UDI record, a new sponsor does not have to duplicate everything, but only needs to add its own data.
What happens if product data changes after the initial submission?
Changes to a UDI record are versioned. The data remains permanently available in the AusUDID – creating a complete change history. Sponsors are responsible for keeping records up to date.
Is the AusUDID publicly accessible?
A UDI record becomes publicly visible once it is linked to an ARTG inclusion. Unlinked records are not publicly accessible.
Which submission pathway is suitable for a portfolio with several hundred products?
For larger quantities, the TGA recommends M2M connection via HL7 SPL. For initial use and medium volumes (up to 200 records), the Excel bulk upload is suitable. Important for HL7 SPL: the TGA requires messages to be validated in advance in the pre-production environment before they are submitted productively.
Can an international manufacturer use its EU or FDA UDI labelling for Australia?
Yes – Australia accepts UDI carriers that fulfil EU or US requirements, provided the UDI-DI comes from a TGA-recognised issuing agency (e.g. GS1, HIBC, ICCBBA). Complete relabelling is usually not necessary in these cases.
Our support
How we support you with AusUDID
From data preparation to automated M2M submission – we support manufacturers and sponsors in a structured and scalable way.
Data field review & preparationAnalysis of your product data with regard to AusUDID requirements. Identification of missing fields and preparation for submission. |
Excel Bulk UploadCompletion and validation of the TGA bulk upload template. Suitable for portfolios of up to 200 records per batch. |
M2M / HL7 SPL processesTechnical support for automated data submission, pre-production validation, and productive connection for large data volumes. |
Manufacturer & sponsor coordinationStructured coordination between manufacturers and Australian sponsors – clearly defined roles, responsibilities, and process steps. |
Deadline managementOverview of the relevant deadlines by product class and planning of implementation steps with sufficient lead time. |
Scalable implementationSolutions for companies with both small and large portfolios – from individual submissions to fully automated AusUDID connection. |
Which AusUDID pathway is right for you?
Whether manual, via bulk upload, or via M2M – we show you how to efficiently prepare and submit your UDI data for Australia. Contact us.
