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.
Labelling and packaging
Find requirements for product labelling and packaging.
-
GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
Advertising
Learn rules and requirements for advertising therapeutic goods.
-
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.
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.
-
PageLearn about UDI requirements for individual device types.