About software and artificial intelligence
Software and artificial intelligence (AI) are medical devices if they help diagnose, monitor, or treat health conditions. Examples include diagnostic apps and AI imaging tools.
These products must be included in the Australian Register of Therapeutic Goods (ARTG) before supply. As the developer or sponsor, you are responsible for ensuring software and AI devices meet quality, safety, and performance requirements. These are outlined in the Therapeutic Goods (Medical Devices) Regulations 2002.
To protect public health in Australia, we assess applications and provide ongoing monitoring and surveillance of device safety.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
