Consultation Hub

Find, read and respond to recent consultations from the Therapeutic Goods Administration (TGA) and also the Office of Drug Control (ODC).

Open consultations are below. Find earlier consultations using the search bar above. We publish submissions after a consultation closes and then add our decisions.

Open consultations

  • Clarification and updates to the regulation of sunscreens

    The Therapeutic Goods Administration (TGA) is seeking public comment on potential clarification and updates to the regulation of sunscreens. The potential regulatory clarification and updates include: Adoption of the Australian/New Zealand Standard Sunscreen products -...

    Closes 31 May 2023

  • Application to amend the Poisons Standard (closed)

    This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’...

    Closes 15 July 2023

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

    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 utilise TGA’s web...

    Closes 24 May 2024

  • 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 24 May 2024

  • 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 22 July 2026

Closed consultations

  • Hospital and healthcare facility point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods ...

    Closed 17 May 2023

  • Dental and oral health professionals point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods ...

    Closed 17 May 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS, JUNE 2023

    Proposed amendments to the Poisons Standard referred to advisory committees We are consulting on applications and delegate-initiated proposals to amend the Poisons Standard. The proposed amendments and any submissions received will be considered at the June 2023 meetings of the...

    Closed 17 May 2023

  • Medical device manufacturing hubs at the point-of-care survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods ...

    Closed 14 May 2023

  • Allied health professionals point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods ...

    Closed 14 May 2023