Purpose and Scope of This FAQ
This FAQ provides sponsors, manufacturers, and regulatory teams with practical answers to common questions about AusUDID requirements, compliance timelines, data submission, and ongoing UDI record management.
This FAQ focuses specifically on Australian UDI and AusUDID compliance, including scope, timelines, responsibilities, data requirements, submission methods, and record maintenance.
It does not provide comprehensive guidance on broader Australian medical device regulations, ARTG inclusion, conformity assessment, post-market requirements, or detailed UDI labelling and direct-marking requirements.
Understanding Australian UDI and AusUDID
The Australian Unique Device Identification Database (AusUDID) is the Australian Government database for storing Unique Device Identifier-Device Identifiers (UDI-DIs) and related information for medical devices supplied in Australia.
UDI records in the AusUDID are linked to relevant inclusions in the Australian Register of Therapeutic Goods (ARTG). Once a UDI record is published and linked to an ARTG inclusion, it becomes publicly available.
AusUDID supports Australia’s broader UDI framework by providing a consistent source of device identification information for regulators, healthcare organisations, clinical registries, industry and consumers.
A UDI is a globally unique identifier used to identify a medical device. It consists of two main components:
- UDI-DI (Device Identifier): The fixed portion that identifies a specific device model or version.
- UDI-PI (Production Identifier): The variable portion that identifies production information such as lot or batch number, serial number, manufacturing date or expiry date, where applicable.
The UDI-DI is submitted to the AusUDID as the Primary DI.
Publicly available UDI records can be searched and downloaded at no cost. This enables patients, consumers, healthcare professionals, clinical quality registries and other stakeholders to access device information. The AusUDID also provides authenticated functionality for sponsors, manufacturers and authorised users responsible for creating and maintaining UDI records.
The ARTG remains Australia’s register of therapeutic goods approved for supply. AusUDID does not replace it. Instead, UDI records are linked to the relevant ARTG inclusion. A UDI record must be linked to at least one ARTG inclusion to become publicly available and satisfy AusUDID submission obligations.
The TGA currently recognises three UDI issuing agencies:
- GS1
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA)
Manufacturers are responsible for selecting a TGA-recognised issuing agency and allocating identifiers according to that agency’s standards.
Potentially, yes. Australia recognises the same three issuing agencies used in major international UDI frameworks.
The TGA accepts UDI carriers that meet US or EU UDI requirements when the UDI-DI was issued by a TGA-recognised issuing agency and the device also complies with Australia’s existing regulatory and labelling requirements.
This can significantly reduce the need for manufacturers to create Australia-specific identifiers solely for UDI purposes.
Key Takeaway
AusUDID complements the ARTG by providing device-level UDI information. Australia’s framework has been designed with international alignment in mind, allowing manufacturers to leverage globally recognised UDI identifiers where Australian requirements are also satisfied.
Scope and Compliance Timelines
Australia is implementing UDI requirements progressively according to device risk classification:
| Class III | 1 July 2026 |
| Class IIb | 1 July 2026 |
| Class IIa | 1 July 2027 |
| Class Is | 1 July 2028 |
Class I non-measuring, non-sterile devices and Class Im measuring devices are not currently required to comply with UDI requirements.
The implementation schedule for IVD medical devices is:
| Class 4 | 1 July 2028 |
| Class 3 | 1 July 2028 |
| Class 2 | 1 July 2029 |
| Class 1* | 1 July 2029 |
*UDI requirements apply to Class 1 IVDs that are instruments or software. Other Class 1 IVDs are not subject to mandatory UDI requirements.
Current TGA exemptions include:
- Devices exempt from ARTG inclusion
- Class I non-measuring, non-sterile medical devices
- Class Im measuring medical devices
- In-house IVDs
- Custom-made medical devices
- Patient-matched medical devices where five or fewer are supplied each financial year
- Devices supplied through the Special Access Scheme or Authorised Prescriber Scheme
- Surgical Loan Kits at the kit level
- Export-only devices that are not supplied in Australia
Specific rules and exceptions can apply, so manufacturers and sponsors should assess individual products against current TGA guidance.
Yes. Manufacturers and sponsors can voluntarily comply before their mandatory compliance date.
For example, a Class IIa device with a 1 July 2027 compliance date can have a UDI applied and its UDI record submitted to AusUDID before that date. Where organisations voluntarily comply, the TGA recommends meeting all applicable UDI requirements rather than implementing only part of the framework.
Certain devices continuing to be supplied under eligible EU MDD transitional arrangements receive additional time to comply with Australian UDI requirements.
The key transitional dates are:
- Class III and Class IIb implantable devices: 1 January 2028
- Class IIb non-implantable, Class IIa and Class Is devices: 1 January 2029
Eligibility depends on the device and the applicable EU MDD-to-MDR transitional arrangements.
If a device benefiting from Australia’s MDD transitional arrangement becomes UDI compliant as part of its transition to EU MDR before the Australian transitional deadline, Australian UDI requirements apply from the date the device becomes UDI compliant. Manufacturers and sponsors therefore need to coordinate EU MDR transition plans with their Australian UDI implementation plans rather than treating the two timelines independently.
Not always. Where direct marking is required, later implementation dates may apply depending on device classification and circumstances.
For example, standard implementation timelines provide later direct-marking milestones after the initial UDI compliance dates. Specific exemptions also apply, including for certain implantable devices and where direct marking would interfere with device safety, performance or effectiveness, or is technically infeasible.
Key Takeaway
Australia’s UDI rollout is risk-based and phased. Don’t determine compliance dates solely from a product’s class as existing-device provisions, EU MDD transitional arrangements, IVD-specific rules and direct-marking requirements can change the applicable timeline.
Sponsors, Manufacturers, and Regulatory Responsibilities
Manufacturers and sponsors share responsibility for UDI compliance, but their roles differ.
Manufacturers are generally responsible for:
- Selecting a TGA-recognised issuing agency
- Allocating the appropriate UDI identifiers
- Applying compliant UDI carriers
- Managing UDI requirements across applicable packaging levels
- Direct marking where applicable
- Providing accurate device information.
Sponsors are responsible for ensuring devices supplied in Australia meet applicable UDI requirements and that accurate UDI information is submitted and maintained in AusUDID. The sponsor ultimately remains responsible for its Australian regulatory obligations.
Yes. Manufacturers can create and publish UDI records containing device data. However, manufacturers cannot provide sponsor-specific data such as ARTG IDs. A manufacturer-published record therefore remains unavailable to the general public until an Australian sponsor links its ARTG inclusion.
The record is published within AusUDID but is not yet publicly available.
A sponsor must locate the record, add its sponsor-specific information and link the appropriate ARTG ID. Once this occurs, the UDI record becomes publicly available and can satisfy the sponsor’s AusUDID submission obligation.
Yes. Sponsors may use manufacturers, agents or third-party solution providers to support UDI submissions.
For example, HL7 SPL supports submissions by sponsors, manufacturers and agents. However, outsourcing the submission process does not transfer the sponsor’s regulatory responsibility. The sponsor remains responsible for ensuring the data submitted on its behalf is accurate and compliant.
For devices subject to UDI requirements, UDI records must generally be submitted within 30 days of the device first being supplied in Australia after the applicable compliance date.
The 30-day period is based on supply in Australia, and not simply the date on which a device was imported.
If device information subsequently changes, the UDI record must also be updated, or a new UDI record created where a UDI Trigger applies, within 30 days of supply of the changed device in Australia.
Only device variants actually being supplied in Australia need to be entered into AusUDID. If an ARTG inclusion covers 100 variants but only 10 are currently supplied in Australia, UDI records are required for those 10. Additional variants must be added when they begin to be supplied in Australia and become subject to the UDI requirements.
Key Takeaway
Manufacturers typically control UDI assignment and core device information, while sponsors remain accountable for Australian compliance, ARTG linkage and the accuracy of records for devices they supply. Clear data ownership and collaboration between the two parties is essential.
AusUDID Data and UDI Records
AusUDID contains mandatory, optional and conditionally mandatory data elements.
Mandatory information includes fields such as the Primary DI and Model/Version.
Conditionally mandatory information is required when specific conditions apply. For example:
- Package DIs are required where applicable higher packaging levels exist.
- Unit of Use DI or Direct Marking DI requirements can apply depending on the device configuration.
- Sterilisation information becomes mandatory in applicable scenarios.
The Australian UDI Data Dictionary should be treated as the authoritative reference for field definitions, permitted values, requirements and update rules.
The Primary DI is the AusUDID data element containing the UDI-DI associated with the base package of the device. It identifies the specific device model or version and must be issued under the rules of a TGA-recognised issuing agency.
The UDI-PI forms part of the UDI carrier and contains variable production information such as serial number, lot or batch, manufacturing date or expiry date. Unlike the UDI-DI, individual production values for each manufactured unit or batch are not submitted as individual records to AusUDID. AusUDID records information describing the applicable production identifier types associated with the device.
UDI Trigger data elements are fields where a change generally requires assignment of a new UDI-DI and creation of a new UDI record.
Examples include:
- Brand Name
- Device Count
- Model/Version
The Australian UDI Data Dictionary identifies the complete set of trigger fields.
Non-UDI Trigger elements can generally be updated without assigning a new UDI-DI.
Examples include:
- Device Description
- Catalogue Number
Although these changes do not require a new UDI-DI, the information must still be kept accurate and current.
They can.
For Software as a Medical Device (SaMD), a major software change that results in a new major version—such as significant changes to algorithms, functionality or the user interface—can constitute a UDI Trigger and require a new UDI-DI. Minor changes do not automatically require a new identifier. Manufacturers need to assess whether the change affects the device’s clinical characteristics, safety, performance, intended purpose, model or major version.
Where applicable, yes.
Higher levels of device packaging generally require their own Package DI. Those package identifiers and packaging relationships must be represented in the UDI record. Logistics units and certain other packaging configurations can be outside these requirements, so packaging hierarchies should be assessed against TGA rules rather than assuming every physical packaging level requires a UDI.
Key Takeaway
AusUDID compliance requires organisations to manage a structured set of device, sponsor, packaging and conditional data and understand which fields can be updated versus which changes require an entirely new UDI-DI.
Submitting Data to AusUDID
The TGA provides four submission methods:
| Submission Method | Typical Use |
|---|---|
| AusUDID Online Portal | Manual submission of individual records |
| Australian UDI Bulk Upload Template | Low-to-medium volumes; up to 200 UDI records |
| Machine-to-Machine via HL7 SPL | High-volume automated submissions |
| Machine-to-Machine via GS1 National Product Catalogue (NPC) | Medium-to-high volumes, particularly for existing NPC users |
All four submission approaches are now documented by the TGA, including the NPC submission pathway updated in August 2026.
The Australian UDI Bulk Upload Template supports up to 200 UDI records per submission. The TGA periodically updates the template and its validation rules, so organisations should use the current supported version rather than maintaining an old template indefinitely.
HL7 Structured Product Labelling (SPL) is an XML-based standard that enables machine-to-machine submission of UDI information.
It is designed primarily for organisations managing larger UDI portfolios or using automated regulatory data submission processes.
The Australian HL7 SPL approach also provides an opportunity for organisations familiar with FDA GUDID machine-to-machine submissions to leverage existing technical knowledge and infrastructure, although Australian data requirements and validation rules still need to be addressed.
Yes. AusUDID supports machine-to-machine submission through GS1’s National Product Catalogue (NPC). This method is particularly relevant for organisations already maintaining product information in NPC or managing medium-to-high UDI record volumes.
There are two environments:
- Production: The live regulatory environment used for official UDI records.
- Pre-Production: A non-production environment used for testing, training and preparing submission processes.
Organisations planning automated submissions should incorporate Pre-Production testing into implementation planning.
The TGA recommends testing the chosen submission method in Pre-Production.
For some submission methods, including HL7 SPL, specific Pre-Production testing must be completed before Production submissions can begin. Pre-Production is therefore particularly important for validating data mappings, business rules and automated submission processes before regulatory records are published.
Yes. UDI records must pass AusUDID validation rules before successful publication.
Validation can include checks that:
- Required fields are populated
- Values conform to permitted code lists and formats
- UDI-DIs conform to the selected issuing agency’s format
- Conditional requirements are satisfied
- Relevant information aligns with ARTG data.
Organisations should validate data before submission rather than relying solely on AusUDID to identify data-quality problems.
Key Takeaway
AusUDID supports both manual and automated submission models. Organisations with significant device portfolios should select their submission method based on volume, existing systems and automation requirements. It is also important to use Pre-Production to validate the end-to-end process before Production.
Maintaining and Correcting UDI Records
The Grace Period is a limited period immediately following the first publication of a UDI record during which users can correct or update any data element without triggering the normal requirement for a new UDI-DI.
The current Grace Period in AusUDID Production is 30 days. The TGA increased the Production Grace Period from 7 days to 30 days in February 2026.
No.
The AusUDID Pre-Production Grace Period is currently one day, allowing organisations to test post-Grace-Period trigger and correction behaviour more quickly. The Production environment currently uses the 30-day Grace Period.
After the Grace Period:
- Changes to UDI Trigger elements generally require a new UDI-DI and new UDI record.
- Non-Trigger elements can continue to be updated.
- Genuine errors involving Trigger fields can be addressed using the AusUDID correction functionality rather than incorrectly creating a new device identity.
The AusUDID records these changes in its audit history.
Yes, where the existing information is genuinely incorrect rather than reflecting an actual change to the device.
Outside the Grace Period, users can use the Correction process and provide the reason for the correction. The TGA may review the reason and the correction.
This distinction is important: correcting erroneous data is different from changing a device characteristic that legitimately triggers a new UDI-DI.
Published UDI records are intended to remain as part of the device’s regulatory history rather than simply being removed when commercial supply ends.
When a sponsor stops supplying a device, it should maintain the appropriate Sponsor Commercial Distribution End Date, and corresponding package distribution end dates where applicable. UDI information remains available to preserve historical device traceability.
UDI information must remain accurate and current while the device is commercially distributed.
Where changed device information does not trigger a new UDI-DI, the existing record must generally be updated within 30 days of the changed device being supplied in Australia. Where the change is a UDI Trigger, a new UDI-DI and UDI record must generally be created within the same 30-day timeframe following supply of the changed device.
Key Takeaway
AusUDID compliance is an ongoing data-management obligation, not a one-time submission exercise. Organisations need processes for detecting product changes, determining whether they trigger a new UDI-DI, correcting errors and maintaining accurate records throughout commercial distribution of medical devices.
Multiple Sponsors and Shared UDI Records
Yes.
Australia allows two or more sponsors to supply the same model of medical device with the same UDI-DI. Rather than creating duplicate records, the sponsors link their respective ARTG inclusions and sponsor-specific information to the same UDI record.
A subsequent sponsor should locate the existing UDI record rather than create a duplicate.
The sponsor then:
- Adds its ARTG ID
- Adds applicable sponsor-specific information, such as its Catalogue Number
- Confirms that the existing device information is accurate and complete.
Once the sponsor adds its information to the existing record, it can satisfy its UDI submission obligation.
AusUDID distinguishes between Device data elements and Sponsor data elements.
Device data elements describe the common device and should remain consistent across sponsors. They are generally based on information controlled by the manufacturer.
Sponsor data elements are specific to an individual sponsor and include information such as:
- ARTG ID
- Catalogue Number
- Sponsor Commercial Distribution End Date.
A sponsor can edit its own sponsor-specific information but not another sponsor’s sponsor-specific data. Changes to shared Device data are recorded through the correction process when multiple sponsors are linked to the record.
Key Takeaway
AusUDID is designed to avoid duplicate device records when the same device is supplied by multiple Australian sponsors. Effective manufacturer-sponsor coordination is therefore critical for maintaining a single, accurate source of shared device information while allowing each sponsor to control its own regulatory data.
Conclusion
Australia’s UDI framework establishes an ongoing requirement to consistently identify devices, maintain accurate regulatory product data and keep that information synchronized with the devices being supplied into the Australian market.
For manufacturers and sponsors, successful AusUDID compliance therefore starts well before the applicable deadline. Organisations should determine which devices are in scope, confirm applicable compliance and transitional dates, establish UDI identifiers and packaging hierarchies, identify authoritative sources for required data, define manufacturer and sponsor responsibilities, select an appropriate submission method and validate their processes through AusUDID Pre-Production.
With mandatory requirements already in effect for Class III and Class IIb devices as of 1 July 2026, the focus for affected organisations should now extend beyond initial submission readiness to sustainable compliance: managing product changes, maintaining data quality, monitoring UDI Triggers and ensuring AusUDID records remain accurate throughout the device lifecycle.
