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.
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
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
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
We want to know what you think about the TGA so we can enhance our support for all panel members. This questionnaire should only take you about 7-10 minutes to complete. The questionnaire focuses...
The TGA would like to know what you think about the Australian Public Assessment Reports (AusPARs) for prescription medicines. This questionnaire should only take a couple of minutes to complete...
TGA Conference Evaluation online form 2018 GMP Forum 26 June 2018