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 and Surveys

  • Instructions For Use for Medical Devices

    The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. The Therapeutic Goods Act 1989 and associated supporting...

    Closes 4 June 2024

  • Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods

    The TGA is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA regulates therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. Products that...

    Closes 9 June 2024

  • Companion diagnostics guidance update- public consultation

    The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the...

    Closes 17 June 2024

  • Updates to Australian medicine labelling rules to support medicine safety

    The Therapeutic Goods Administration (TGA) is seeking feedback on proposed changes to the rules for Australian medicine labels. We want to make sure that certain information important to health professionals is displayed clearly on labels or is available in the appropriate format. We...

    Closes 11 July 2024

Applications and Forms

  • Form: Annual Reporting of Custom-made medical devices

    Manufacturers and sponsors of custom-made medical devices must supply an annual report to the TGA, detailing all of the custom-made medical devices they have manufactured and/or supplied within the preceding 1 July - 30 June financial year. The report must be submitted by 1 October each year....

    Closes 30 November 2032

  • 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

  • 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