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Software based medical devices, including those using AI, must follow regulatory requirements for labelling and advertising.
Labelling includes digital information shown within software or on a website. It must clearly state the device’s purpose, instructions, warnings and the software version or build number. Labelling requirements are set out in the Essential Principles.
Advertising must be truthful, evidence-based, and not misleading. Claims about diagnosis or treatment must meet legal standards and codes.
These requirements help protect users and ensure safe, legal supply in Australia. We monitor compliance and can take enforcement action if advertising rules are broken.
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.