Review of draft guidance documents - Audit framework for medical devices

The Therapeutic Goods Administration (TGA) is seeking feedback on two new guidance documents developed as part of the new risk-based application audit framework: 1. Draft Guidance - Selection criteria for non-mandatory application audits. This guidance document outlines and...

Closes 17 February 2025

Public consultation on proposed amendments to the Poisons Standard - ACCS & Joint ACMS-ACCS, MARCH 2025

Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the MARCH 2025 meeting of the Advisory...

Closes 17 February 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