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 11 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

Additional public consultation on the scheduling of ethylene oxide, propylene oxide and epichlorohydrin

Proposed scheduling amendments for ethylene oxide, propylene oxide and epichlorohydrin This consultation is in relation to a proposal to amend the current scheduling of ethylene oxide, propylene oxide and epichlorohydrin. All the three substances are listed is the current Poisons...

Closes 26 October 2026

Form: Confirmation of M2M HL7 SPL testing completion

This form is for medical device sponsors, manufacturers, or agents. It lets you advise the Therapeutic Goods Administration (TGA) that you confirm that your organisation has completed M2M HL7 SPL testing in accordance with the validation procedure in the M2M HL7 SPL – User Guide – AusUDID...

Closes 1 January 2100

Form: Intent to submit to AusUDID using M2M HL7 SPL

This form is for medical device sponsors, manufacturers, agents or third party data providers. It lets you advise the Therapeutic Goods Administration (TGA) that you plan to submit data to the Australian Unique Device Identification Database (AusUDID) using the M2M HL7 SPL submission...

Closes 1 January 2100

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