When labelling and advertising implantable medical devices, you must follow regulations to ensure information is clear, accurate, and not misleading.
Labels and packaging must include key details like the Unique Device Identification (UDI), intended use, instructions, warnings and patient information materials.
Advertising must be honest and backed by evidence. It must not overstate the benefits of your device, make claims that are not allowed or imply our endorsement.
We monitor compliance to help protect patients and maintain trust in your device.
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 medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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PagePatient information leaflets (PILs) and Patient Implant Cards (PICs) are required for all breast implants.
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PageAll implantable and active implantable medical devices must come with patient information materials.
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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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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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PageUnderstand and apply the UDI labelling and packaging requirements to your medical devices.
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PageLearn about UDI requirements for individual device types.