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.
-
PageInformation on the different types of face masks and respirators.
-
PageRegulatory information on the labelling and packaging of medicines and medical devices
-
GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
Advertising
Learn rules and requirements for advertising therapeutic goods.
-
PageInformation about what is considered advertising, if advertising is allowed for your product and using the Advertising Code.
-
DatasetSearch notices of approved and permitted restricted representations.
-
PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the general 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 part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
-
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 Identifiers
Understand and apply Unique Device Identifier requirements.
-
PageThis document supports UDI awareness and adoption in Australian healthcare settings.
-
PageAn introduction to UDI and its role in device identification, traceability, and patient safety in Australian healthcare.
-
PageUnderstand and apply the UDI labelling and packaging requirements to your medical devices.