System and procedure packs must meet legal requirements for labelling and advertising.
Labels must clearly show the pack’s purpose, instructions, warnings, and include patient info if needed.
Advertising must be accurate, backed by evidence and must not be misleading. You are responsible for compliance across all platforms.
We monitor for compliance and can take enforcement action if these rules are broken. Following these rules is essential for legal supply and safe use in Australia.
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.
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.
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.