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Labelling and advertising for implantable devices

Information on how to make sure your implantable device meets labelling, packaging, and advertising standards.

When labelling and advertising implantable medical devices, you must follow regulations to ensure information is clear, accurate, and not misleading. 
 

Labels and packaging must include key details like the Unique Device Identification (UDI), intended use, instructions, warnings and patient information materials. 
 

Advertising must be honest and backed by evidence. It must not overstate the benefits of your device, make claims that are not allowed or imply our endorsement. 
 

We monitor compliance to help protect patients and maintain trust in your device. 
 

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.

Advertising

Learn rules and requirements for advertising therapeutic goods.

  • Applying the Advertising Code

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    The 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.

Product types