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Labelling and advertising for personalised medical devices

Information on how to ensure your product meets labelling, packaging, and advertising standards for personalised medical devices. 

Personalised medical devices must meet labelling and advertising regulatory requirements.   
  

The regulations outline what information you need to provide with a medical device. Implant cards and patient information leaflets are also needed for implantable devices.  
  

Advertising must be truthful, not misleading, and supported by evidence.   
  

You are responsible for compliance across all information materials and platforms. 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 personalised 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.

  • Advertising basics

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    Information about what is considered advertising, if advertising is allowed for your product and using the Advertising Code.

  • 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 public.

Unique Device Identification

Understand and apply Unique Device Identification (UDI) requirements.

Product types