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.

Applications and Forms

  • 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

  • Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification

    From 1 July 2023, sponsors may apply for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification. Background In accordance with the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 , certain...

    Closes 30 June 2029

  • 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