We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Promoting voluntary compliance
We aim to promote voluntary compliance of software and AI medical devices. We provide education and guidance to help people meet the regulatory requirements.
We changed the medical device regulations for software and AI products in 2021. This made it easier for people to understand when we regulate their products. We publish information, provide training, and answer enquiries. This ensures people understand the changes and supports voluntary compliance.
Compliance and enforcement
One of our functions is to manage non-compliance of software and AI medical devices. Our compliance activities will target advertising and supply of software as a medical device that are not on the Australian Register of Therapeutic Goods (ARTG). This will include reviewing digital scribes that have additional features, such as diagnostic and treatment recommendations.
We continue to support voluntary compliance through education and guidance. We may take targeted action in response to alleged non-compliance. This is consistent with our regulatory compliance framework.
Report suspected non-compliance
If you suspect non-compliance of medical devices or their advertising, report it to us at any time.