Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2024

Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the JUNE 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on...

Closes 18 October 2024

Clarifying and strengthening the regulation of Artificial Intelligence (AI)

Artificial Intelligence (AI) has already made a difference to many lives, providing the potential to solve problems faster, and opening up opportunities to get things done in smarter and better ways. If safely deployed, its development and adoption can improve wellbeing, quality of life and...

Closes 20 October 2024

Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, November 2024

Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the November 2024 meetings of the ...

Closes 22 October 2024

Consultation: Future regulation of assistive technologies

The TGA is seeking feedback on proposed changes to the regulation of assistive technologies. The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical...

Closes 31 October 2024

Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

UPDATE: Our response to questions asked during the consultation presentation on 11-12 September 2024 has been added to the related documents below the other consultation document links. We have also included a link to the presentation slides. The Therapeutic Goods Administration (TGA) is the...

Closes 13 November 2024

NOTIFICATION FORM: Clinical decision support software exemption

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 decision...

Closes 25 December 2031

Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR

Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to...

Closes 31 July 2029

Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR

This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take...

Closes 31 July 2029