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About medical devices
Medical devices can be any product or software (including AI) that is intended by the supplier to be used for a therapeutic purpose in or on human beings.
Importantly, a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means.
This includes a wide range of products, for example, medical gloves, bandages, syringes, blood pressure monitors, pregnancy test kits and X-ray equipment.
Unless exempt or excluded, all medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia. We apply different levels of regulation to devices depending on their risk.
From 1 July 2026, medical devices are required to have a UDI (Unique Device Identification). Starting with higher risk (class IIb and III) devices, UDI will help us -consumers, health professionals, industry and other stakeholders – easily access device information.
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 products.
