Digital mental health tools: Service provider survey

The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to digital mental health tools (DMHTs). DMHTs are software products including apps, websites, or platforms, that offer assessments, therapy, or self-management strategies to support mental health care. ...

Closes 7 August 2026

Proposed changes to the Permissible Indications Determination

Proposed changes to the Permissible Indications Determination Listed medicines are considered low-risk medicines as they can only use low-risk ingredients and make low-level indications. These medicines are not individually evaluated by the Therapeutic Goods Administration (TGA) before they...

Closes 12 August 2026

ODC Medicinal Cannabis Permit Holder Supply Pathways 2026

The Office of Drug Control (ODC) is seeking feedback from permit holders under the Narcotic Drugs Act 1967 on supply pathways used by industry participants. Your feedback will help the ODC better understand current industry practices and identify opportunities to develop practical...

Closes 16 August 2026

Improvements to the Therapeutic Goods Advertising Code

The Therapeutic Goods Administration (TGA) within the Department of Health, Disability and Ageing is seeking feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code). We are reviewing parts of the Code to...

Closes 3 September 2026

Proposed changes to Required Advisory Statements for Medicine Labels (RASML)

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed changes to the Required Advisory Statements for Medicine Labels (RASML) . RASML sets out advisory statements that are required to be included on the labels of specified OTC and registered...

Closes 4 September 2026

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

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