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.
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.
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 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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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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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.