Personalised medical devices must meet labelling and advertising regulatory requirements.
The regulations outline what information you need to provide with a medical device. Implant cards and patient information leaflets are also needed for implantable devices.
Advertising must be truthful, not misleading, and supported by evidence.
You are responsible for compliance across all information materials and platforms. Following these rules is essential for legal supply and safe use in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to personalised 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 medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
Advertising
Learn rules and requirements for advertising therapeutic goods.
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PageInformation about what is considered advertising, if advertising is allowed for your product and using the Advertising Code.
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PageLearn what can and can't be advertised for personalised medical devices.
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PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the general public.
Unique Device Identifiers
Understand and apply Unique Device Identifier requirements.
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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.