Australian TGA To Introduce AusUDI


The Australian regulatory, the Therapeutic Goods Administration (TGA), has announced the intention to introduce an Australian UDI System.

There has been much discussion globally around the introduction of such systems. The United States set about laying the foundations with the introduction of their UDI requirements several years ago, with the EU now to introduce similar (but not identical) requirements alongside the approaching MDR and IVDR.

Following a round of consultations with industry, the TGA published on their website on August 14 2019 that feedback has informed work to develop proposed legislative amendments to support the introduction of a UDI system in Australia:

The implementation of UDI in Australia was raised as a specific topic at the recent Sydney ARCS conference – in a panel discussion between TGA representatives Elizabeth McGrath, Mimi Chou-Gourlay and Arthur Brandwood. TGA has always supported the principle that imported devices can be supplied in Australia with no or minimal change to international labelling. The discussion at ARCS centred on how TGA will continue to do so given the potential incompatibilities between international implementations of UDI – e.g. US vs. Europe implementations. The challenge is to implement UDI in a way that is agnostic to the European, US and other international formats. The agency is certainly well aware of these challenges and is actively exploring how to implement UDI without adding unnecessary relabelling burden on manufacturers.

Assuming the feedback is used to assist in the development of such a system, we can only hope that we see reasonable time frames that give industry and government a chance to implement.

If you have any questions on your UDI, be sure to reach out to Brandwood CKC for a no obligation discussion.

We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)


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