Priority Assessment Tool feedback

The Business Transition and Support Section receives business requests for enhancements to the current IT systems. We have developed a Prioritisation Assessment Tool (PAT) that contains a set of criteria, each with a weighting. It will be used to calculate the business value of IT requests to help...

Closes 25 August 2025

Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products

Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products The purpose of this consultation paper is to gather information on stakeholders’ experiences, observations and knowledge of the use of unapproved medicinal cannabis products. Information obtained...

Closes 7 October 2025

Application to amend the Poisons Standard (March 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 7 November 2025

Medical device Adverse Signal Detection and Event Reporting (ASDER) Checklist

Purpose of the checklist: Verification of your facilities readiness prior to the rollout of SharePoint invitation links for the ASDER System

Closes 31 December 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