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.
Labelling and packaging
Find requirements for product labelling and packaging.
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
Advertising
Learn rules and requirements for advertising therapeutic goods.
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DatasetSearch notices of approved and permitted restricted representations.
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PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the general public.
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GuidanceGuidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.
Unique Device Identifiers
Understand and apply Unique Device Identifier requirements.
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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PageThis document supports UDI awareness and adoption in Australian healthcare settings.
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PageAn introduction to UDI and its role in device identification, traceability, and patient safety in Australian healthcare.
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PageLearn about UDI requirements for individual device types.