Regulatory Update: Australia’s UDI Regulation Now in Effect

We’re pleased to share that Australia’s Unique Device Identification (UDI) regulatory framework is now officially in effect, marking a major milestone in strengthening patient safety and medical device traceability.

The Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 was registered in the Federal Register of Legislation on 24 March 2025, establishing the legislative foundation for UDI in Australia. This framework introduces a phased approach to compliance, with mandatory UDI requirements starting in July 2026 for high-risk and implanted medical devices. Other device classes will follow based on their risk category.

From now until the applicable compliance dates, sponsors and manufacturers may voluntarily begin meeting UDI requirements, including submitting UDI records to the Australian UDI Database (AusUDID). AusUDID is a central database that stores UDI-DIs and related data for medical devices supplied in Australia, and is freely accessed by health professionals, patients, and consumers. Initial data submission options include an Online Portal and Microsoft Excel Template for Bulk Upload. The TGA (Therapeutic Goods Administration) expects to provide more guidance on Machine-to-Machine submission methods via HL7 SPL and the National Product Catalogue (NPC) in May 2025, which Innovit is closely monitoring.

A wide range of resources and guidance materials are available to understand AusUDID submission requirements, timelines, and more.

For more details and access to resources from the TGA, visit the TGA’s Unique Device Identification Hub.

To understand how Innovit can help you in your journey to UDI compliance in Australia, visit our AusUDID UDI Reference Center.