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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PageLearn about patient information materials for healthcare and consumers.
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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 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 Identification
Understand and apply Unique Device Identification (UDI) requirements.
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PageThe Australian Unique Device Identification Database (AusUDID) Conceptual Model provides a high-level view of the information available in the AusUDID and the relationship between entities.
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PageLearn how UDI can enable improved patient safety, support recalls and adverse event management, and enhance device traceability across the healthcare system.
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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PageLearn about Australia's Unique Device Identification (UDI) system, its purpose, and how it supports safer and more effective healthcare.
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PageLearn how healthcare organisations can prepare for UDI adoption, including changes to systems, processes and clinical workflows.
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PageUnderstand which medical devices are subject to UDI requirements and how the requirements apply across different device types.
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PageUnderstand the responsibilities of different stakeholders in implementing and adopting Australia’s Unique Device Identification (UDI) system.
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PageUnderstand UDIs, Unit of Use DIs, Direct Marking DIs, and other identifiers used in the Australian UDI framework and how they relate to identifiers already used in healthcare, procurement, inventory and billing systems.
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PageLearn how the Australian UDI Database (AusUDID) supports healthcare organisations to identify medical devices and access device information.