When labelling and advertising medical devices, you must comply with regulations to ensure information is clear, truthful, and not misleading.
Labels and packaging should include essential details like intended use, instructions, and any required warnings.
Advertising must be honest, accurate, and supported by evidence.
We monitor advertising to ensure compliance with these rules. Following these requirements helps protect users and maintain trust in your medical device.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about medical devices, and specific types of medical devices. You may also have to meet obligations that apply to all products.
Labelling and packaging
Find requirements for product labelling and packaging.
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PageA new version of the code of practice for tamper-evident packaging of therapeutic goods is now available.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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PageLabelling and other information provided with medical devices.
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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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PageInformation about what is considered advertising, if advertising is allowed for your product and using the Advertising Code.
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PageHow we manage advertising compliance, and where to find information about enforcement outcomes.
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PageInformation on the legal and regulatory framework underpinning our rules on advertising therapeutic goods.
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DatasetSearch notices of approved and permitted restricted representations.
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GuidanceGuidance to help you understand requirements for disease information and advertising.
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GuidanceThis guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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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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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 parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
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GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
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GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
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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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User guideApply for our approval to use a restricted representation in advertising.
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GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
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PageHow advertising of therapeutic goods needs to be accurate, balanced and safe. This relates to Part 3 of the Advertising Code.
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ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.
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PageAn overview of the types of information that must be included in advertisements about therapeutic goods. Relates to Parts 4 and 5 of the Advertising Code.
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ServiceUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
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PageLearn what the requirements are associated with advertising therapeutic goods in relation to weight management.
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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.
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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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PageUnderstand what can be used as a free sample in therapeutic goods advertising and the rules around offering incentives. Relates to Part 7 of the Advertising Code.
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PageExplore advertising information on specific topics, such as social media and goods like Ozempic. Find out ways to promote health services offering products that cannot be advertised to the public.
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PageRequirements for endorsements and testimonials shown in advertisements about therapeutic goods. Relates to Part 6 of the Advertising Code.
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PageFind out how claims such as 'TGA approved' must not be used in advertisements for therapeutic goods.
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PageThe trade name of a therapeutic good must comply with therapeutic goods legislation, including advertising legislation.
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LegislationThis Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.
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GuidanceGuidance about when information released to the public about therapeutic goods is considered advertising.
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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.
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PageHow you can use terms such as 'natural' without misleading consumers.
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PageThere are specific requirements for using scientific or clinical terminology in advertising or giving support to claims by referring to scientific research. Relates to Part 3 of the Advertising Code.
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PageLearn which therapeutic goods can and cannot be advertised to the public.
Unique Device Identifiers
Understand and apply Unique Device Identifier requirements.
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PageThe Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata.
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PageLearn about the Australian UDI Database (AusUDID), the public database where you can find information about medical devices supplied in the Australian market.
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PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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PageUnderstand if Unique Device Identification (UDI) applies to your devices, learn how to comply and get familiar with the Australian UDI Database (AusUDID)
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PageResources and technical documents for Machine to Machine (M2M) HL7 SPL users in the Australian Unique Device Identification Database (AusUDID).
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PageLabelling and packaging information about medical devices Unique Device Identification (UDI).
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PageThis document supports UDI awareness and adoption in Australian healthcare settings.
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ChecklistsThis checklist outlines key considerations for sponsors and manufacturers seeking to comply with Australia’s Unique
Device Identification (UDI) requirements. -
PageLearn about your obligations in meeting UDI requirements in Australia.
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PageLearn about the Australian Unique Device Identification Database (AusUDID) and how to use the database to comply with UDI requirements.
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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 Unique Device Identification (UDI) requirements to your medical devices.
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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.
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PageResources and technical documents for sponsors, manufacturers, consumers, and healthcare professionals.
Product types