Australia in the GSP:
Capture UDI data in a structured way, validate it, and centrally manage it for the AusUDID workflow
The Global Submission Portal continues to grow: following its launch with FDA eMDR, FDA GUDID and EUDAMED UDI, as well as its expansion to include EUDAMED Vigilance, we now also support Australia. This makes the GSP an even stronger central platform for global regulatory submission processes.
This timing has been chosen deliberately. Australia already introduced its UDI system from a regulatory perspective in 2025, the Australian UDI Database (AusUDID) is live, and implementation is being rolled out in a risk-based approach over several years. For manufacturers and sponsors of Class III and Class IIb medical devices, UDI will become mandatory from July 1, 2026, with further classes to follow in the years thereafter.
AusUDID: Central data foundation for the Australian market
With AusUDID, the TGA is establishing a central data foundation for UDI-DIs and the associated device data in Australia. The published UDI datasets are linked to the relevant ARTG entries.
This is exactly where the Global Submission Portal comes in: it helps prepare UDI-relevant data in a structured way, organize review and approval processes more effectively, and transfer submission workflows into one consistent environment.
Australia as part of the global UDI strategy
This is especially important for internationally operating MedTech companies: Australia is no longer an isolated special case, but another market that must be integrated into the global UDI strategy. Companies that already manage FDA or EUDAMED processes benefit from a harmonized approach instead of adding more isolated solutions.
This standardization is exactly the GSP approach:
- fewer media discontinuities
- greater transparency
- clearer status tracking
- and better operational control of regulatory submissions
Role logic in Australia: Sponsor, manufacturer, regulatory team
From a regulatory perspective, role logic in Australia is important: sponsors remain responsible for the submission and maintenance of UDI records. While manufacturers can carry out many operational steps in AusUDID, the linkage to the ARTG remains sponsor-relevant. For companies with international structures, it is therefore not only data capture that matters, but also a cleanly managed workflow between manufacturer, sponsor, and regulatory team.
One platform. All markets. Done.
With the expansion to include TGA Australia / AusUDID, Europe IT Consulting continues to systematically develop the Global Submission Portal. The goal remains unchanged: to make global submission processes for MedTech companies clearer, more robust, and more efficient – in one system.
Submit your request directly here: https://udi.europe-it-services.com/
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