Adoption of International Scientific Guidelines in Australia R01-2026

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 consultation to...

Closes 25 September 2026

Proposed changes to support automated decision making (ADM) for applications to change listed medicines

Proposed changes to support automated decision making (ADM) for applications to change listed medicines Medicines listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A of the Therapeutic Goods Act 1989 (the Act) are included in the ARTG without pre-market...

Closes 30 September 2026

Public consultation | Sharing more information about medical devices

We want your feedback on our proposal to improve sharing information about the safety, quality and performance of medical devices. This will take about 15 minutes to read and complete. The proposed changes intend to provide more information to the public after post-market reviews or...

Closes 2 October 2026

Public consultation on proposed amendments to the Poisons Standard in relation to nitrous oxide – Joint ACMS-ACCS #45 – November 2026

This consultation is for two proposals to amend the current scheduling of nitrous oxide to manage the increasing public health risks from its misuse. The first proposal is initiated by the Delegate and the second proposal has been submitted by a private applicant. Currently,...

Closes 12 October 2026

Public consultation on proposed amendments to the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC) – Joint ACMS-ACCS #45, November 2026

This consultation is for a proposal to amend the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC). The Delegate and two private applicants have proposed 3 different options to schedule 4-MBC which is not listed in the current Poisons Standard. Option 1 (proposed by the...

Closes 12 October 2026

Public consultation on proposed amendments to the Poisons Standard – ACCS #43 – NOVEMBER 2026

Scheduling amendments referred to the Advisory Committee on Chemicals Scheduling This consultation is for Delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the November 2026 meeting of the ...

Closes 12 October 2026

Notification form: Lapses in medical device conformity assessment certification

Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. Notifying the...

Closes 31 July 2035

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