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.
-
PageLabelling and other information provided with medical devices.
-
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.
-
PageHow we manage advertising compliance, and where to find information about enforcement outcomes.
-
-
PageInformation on the legal and regulatory framework underpinning our rules on advertising therapeutic goods.
-
DatasetSearch notices of approved and permitted restricted representations.
-
GuidanceGuidance to help you understand requirements for disease information and advertising.
-
GuidanceThis guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
-
GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
-
PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the public.
-
GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
-
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.
-
GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
-
GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
-
GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
-
User guideApply for TGA approval to use restricted representations in therapeutic goods advertising. Step‑by‑step guidance on requirements and assessment.
-
GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
-
GuidanceThis guidance assists entities who disseminate content about therapeutic goods and vaping goods to determine if their material is considered advertising.
-
PageHow advertising of therapeutic goods needs to be accurate, balanced and safe. This relates to Part 3 of the Advertising Code.
-
ChecklistsThis checklist helps you assess whether your advertising complies with legislative requirements.
-
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.
-
TransactionReport non-compliant advertisement for a medicine, medical device or any other type of therapeutic good, using our online portal.
-
PageLearn what the requirements are associated with advertising therapeutic goods in relation to weight management.
-
PageThere are restrictions on using representations in advertising that refer to certain diseases, ailments or conditions. Relates to Part 8 of the Advertising Code.
-
ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
-
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.
-
PageLearn about the requirements for advertising therapeutic goods in specific circumstances, such as social media, and for specific types of products, like weight loss injections.
-
PageRequirements for endorsements and testimonials shown in advertisements about therapeutic goods. Relates to Part 6 of the Advertising Code.
-
PageFind out how claims such as 'TGA approved' must not be used in advertisements for therapeutic goods.
-
PageThe trade name of a therapeutic good must comply with therapeutic goods legislation, including advertising legislation.
-
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.
-
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.
-
PageHow you can use terms such as 'natural' without misleading consumers.
-
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.
-
PageLearn which therapeutic goods can and cannot be advertised to the public.
Unique Device Identification
Understand and apply Unique Device Identification (UDI) requirements.
-
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.
-
PageLearn how UDI can enable improved patient safety, support recalls and adverse event management, and enhance device traceability across the healthcare system.
-
PageUnderstand how to get a UDI and which UDIs from other jurisdictions are accepted in Australia.
-
User guideLearn how to manage UDI records when a device is supplied by more than one sponsor.
-
PageLearn which changes to a device are considered a UDI Trigger, and how to manage these changes.
-
PageLearn about Australia's Unique Device Identification (UDI) system, its purpose, and how it supports safer and more effective healthcare.
-
PageLearn how healthcare organisations can prepare for UDI adoption, including changes to systems, processes and clinical workflows.
-
PageUnderstand which medical devices are subject to UDI requirements and how the requirements apply across different device types.
-
PageUnderstand the responsibilities of different stakeholders in implementing and adopting Australia’s Unique Device Identification (UDI) system.
-
PageLearn about each type of identifier required under the Australian UDI framework.
-
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.
-
PageLearn how the Australian UDI Database (AusUDID) supports healthcare organisations to identify medical devices and access device information.
Product types