This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 .
The exemption applies to medical devices that are clinical...More
Welcome
You are now on the Australian Unique Device Identification Database ( AusUDID) Sandpit registration page.
You can return to the UDI Hub to view other AusUDID information at any time.
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From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to...More
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.
Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external...More
The Therapeutic Goods Administration (TGA) is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).
We are seeking feedback on:
whether references to the TGA should...More
The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia.
The TGA have created a...More
Potential Scheduling amendments referred to expert advisory committee.
This consultation is for possible delegate-initiated proposals to amend the Poisons Standard with regards to paracetamol. The suggested amendments and any submissions received will be considered at the ...More
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical...More
The Therapeutic Goods Administration (TGA) is requesting feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by...More