At Innovit, we support some of the world’s leading medical device companies with UDI compliance, many of whom have already tackled UDI requirements in the U.S. (GUDID) and Europe (EUDAMED).
Now, with Australia rolling out its own Unique Device Identification (UDI) framework through AusUDID, we’re hearing a familiar question from sponsors and manufacturers:
“What’s the most cost-efficient and reliable way for machine-to-machine UDI submissions to AusUDID?”
It’s a great question—and one we’ve helped answer in markets around the world. In this post, we’ll explore what sponsors and manufacturers should consider when evaluating machine-to-machine (M2M) UDI submission strategies to AusUDID.
It is worth noting that the Therapeutic Goods Administration (TGA) has currently provided two M2M device submission methods:
- Machine-to-Machine via NPC – Medium to high-volume option for users of the National Product Catalogue (NPC), enabling data submissions to AusUDID via the NPC.
- Machine-to-Machine HL7 SPL – For manufacturers and sponsors with high-volume of device records, and integrating directly with AusUDID using the HL7 Structured Product Labeling (SPL) standard.
In the sections below, we’ll compare the two approaches for high-volume UDI data submissions.
Option 1: Using NPC for UDI submissions to AusUDID
| PROS | CONS |
|---|---|
| Single system for both commercial and regulatory data submissions | NPC is primarily designed for commercial data, not regulatory – misalignment may occur |
| Leverages existing NPC infrastructure and investment | Frequent NPC updates may trigger unnecessary validation efforts unrelated to UDI |
| Unified training for regulatory and commercial teams | NPC may not adhere to TGA’s GAMP 5 system validation requirements |
| Simplified IT landscape (one data pipeline) | Limited support for non-GS1 issuing agencies (e.g. HIBCC, ICCBBA) |
| Indirect submission may reduce visibility into acknowledgement/error messages from the AusUDID as they are converted to NPC Catalogue Item Confirmation (CIC) messages | |
| Increased complexity in data lineage and mapping (internal → NPC → AusUDID) | |
| There may be potential costs associated with additional AS2 mailboxes | |
| Reliance on a GDSN data pool can be risky if priorities for the data pool shift away from the healthcare/life sciences industry |
Option 2: Direct M2M Submission to AusUDID
| PROS | CONS |
|---|---|
| Clear traceability and attribute alignment with AusUDID requirements | Requires a separate solution from commercial data syndication via the NPC |
| Rapid adaptation to regulatory updates and changes by the TGA | Higher initial investment in setup and training |
| Full visibility into TGA acknowledgement/response messages | May require multiple integration points to support regulatory data vs. commercial data publication requirements |
| Lower system validation costs – no dependency on NPC upgrade schedules | |
| Easier ability to comply with GAMP 5 system validation standards, as well as other quality & traceability requirements (e.g. 21 CFR Part 11, Annex 11) | |
| Better flexibility for supporting non-GS1 identifiers (e.g. HIBCC, ICCBBA) |
Key Takeaways
Submitting via the NPC simplifies data flow by using a single channel that users may already be used to, but may introduce added complexity around system validation, agility to respond to compliance requirements, and visibility into direct message exchanges with AusUDID.
Direct M2M integration with AusUDID via HL7 SPL provides closer alignment with TGA requirements, greater agility, enhanced data quality, and easier traceability, making it ideal for high-assurance regulatory environments.
Conclusion
There is no single M2M approach that will be right for every organization. The decision should reflect your existing technology landscape, regulatory operating model, submission volumes, validation requirements, and long-term UDI strategy.
For organizations already invested in NPC, extending that infrastructure to AusUDID may provide a practical path forward. For those prioritizing direct regulatory connectivity, greater control over submissions, and a scalable approach to UDI compliance, direct M2M integration may offer a stronger long-term foundation.
Whichever approach you choose, the goal should be to build a submission process that is reliable today while remaining adaptable as AusUDID requirements and your regulatory needs evolve.
