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.
Related links
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Find out how TGA regulates software and artificial intelligence (AI) based medical devices.
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Flowcharts guiding developers and users of software to decide which software and apps are medical devices.
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Information for software manufacturers when AI is considered a medical device, and how we regulate AI medical devices.
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Guidance on interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.
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This document forms the final report for the Safe and Responsible Artificial Intelligence (AI) in Health Care Legislation and Regulation Review (the review).
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New classification rules and amended Essential Principles clarify regulation of software-based medical devices.
Page history
Version: V1.0
Description of change: Original publication
Author: Devices Specialist Evaluation Section
Effective date: August 2025
Version: V1.0
Description of change: Original publication
Author: Devices Specialist Evaluation Section
Effective date: August 2025