Personalised medical devices consumer survey

The Therapeutic Goods Administration (TGA) regulates medical devices to ensure they are safe and work as intended. We regularly review and update our rules to keep pace with technology and protect patients and consumers. We are currently reviewing personalised medical devices. These are...

Closes 24 April 2026

Improvements to the regulation of sunscreens in Australia

Seeking feedback on improvements to the regulation of sunscreens in Australia Recent international and domestic developments have highlighted a number of matters in relation to the current regulation of sunscreens. Given Australia has the highest rates of skin cancer and melanoma in the...

Closes 23 May 2026

Application to amend the Poisons Standard (NOVEMBER 2026)

This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’...

Closes 10 July 2026

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