Personal protective equipment (PPE) medical devices must follow strict rules for labelling and advertising in Australia.
Labels must clearly show the device’s purpose, instructions, warnings, and patient info if needed.
Advertising must be truthful, evidence-based, and not misleading. You’re responsible for compliance across all platforms.
We monitor this and can take enforcement action if rules are broken. Following these rules is essential for legal supply and safe use of PPE.
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 how the TGA regulates face masks and respirators used during COVID‑19, including safety requirements, classifications, and guidance for consumers and suppliers.
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PageLearn about Australia’s requirements for labelling and packaging of therapeutic goods, including regulatory standards to ensure product safety, quality, and accurate information for consumers.
Advertising
Learn rules and requirements for advertising therapeutic goods.
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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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GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
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GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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PageThere are restrictions on using representations in advertising that refer to certain diseases, ailments or conditions. Relates to Part 8 of the Advertising Code.
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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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.