Public consultation on interim decision to amend the Poisons Standard in relation to nicotinic acid and IV potassium

Interim decision This consultation is for an interim decision in relation to nicotinic acid and IV potassium. Once you are familiar with the interim decision, please provide your comments and votes in relation to the interim decision. The closing date for this consultation is...

Closes 7 January 2025

Medicine shortages and discontinuations: Proposed changes to reporting requirements

Medicines are essential for the health and wellbeing of Australians. Medicine shortages can occur for various reasons. Unfortunately, some are unavoidable and can cause significant impact. Through our mandatory reporting scheme, the Therapeutic Goods Administration (TGA) receives and...

Closes 13 January 2025

Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices

The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document being drafted for the Australian UDI system: ‘Complying with the Unique Device Identification regulations for medical devices.’ Please note the following: This document will be published...

Closes 15 January 2025

Adoption of International Scientific Guidelines in Australia R01-2024

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 16 January 2025

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

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