A tailored TGA UDI consultation helps you identify the exact regulatory obligations for your device type and prepare accurate submissions that are aligned with Australian legislation and international guidelines.
The Therapeutic Goods Administration (TGA) has finalised the Unique Device Identification (UDI) framework, with formal amendments to the Medical Device Regulations registered on the Federal Register of Legislation as of 24 March 2025. This marks a significant step toward strengthening post-market traceability and supply chain transparency for medical devices in Australia.
With these changes in effect, sponsors and manufacturers must update their compliance strategies to meet new data submission, labelling, and registration requirements.
Expert UDI Consulting from Vicki Partridge
Vicki Partridge offers targeted UDI consultation services to help you confidently navigate the TGA’s evolving requirements. With in-depth knowledge of Australian regulatory processes and global frameworks, Vicki supports sponsors and manufacturers in implementing UDI systems that efficiently meet compliance obligations.
Whether you are preparing to enter the Australian market or reviewing existing listings on the Australian Register of Therapeutic Goods (ARTG), her expertise ensures that your approach is structured and compliant.
Align Your UDI with Risk-Based Obligations
The UDI framework differs based on device classification; it’s crucial to understand how your product fits within the medical device risk classes. Aside from providing expert TGA UDI consultation, Vicki helps determine the required identifiers, correct labelling format, and appropriate data submissions based on your product category and associated risks.
Get Practical Guidance on TGA UDI Requirements
If you need help meeting UDI requirements in Australia, Vicki Partridge offers professional TGA UDI consultation tailored to your device. Contact her office at +61 7 55295508 to avoid delays and reduce non-compliance risks.