When labelling and advertising in vitro diagnostic (IVD) medical devices, you must follow regulations. The labelling and advertising must be clear, accurate and not misleading.
Labels and packaging need to include information about:
the intended use
instructions
warnings
information to ensure accurate use of the device.
Labelling and packaging must also comply with the Essential Principles and Advertising Code.
Advertising must be truthful and supported by evidence. It must not overstate the benefits, make unapproved claims or suggest our endorsement.
We check compliance to help protect users and patients and build trust in your device.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. You may also have to meet obligations that apply to all medical devices and all products.
Advertising
Learn rules and requirements for advertising therapeutic goods.
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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PageFind information about advertising COVID-19 rapid tests.
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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 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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LegislationThe Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 introduces the Unique Device Identification (UDI) system in Australia.
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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.