Site notifications

Sub menu

 

 

Labelling and advertising for medical devices

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

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.

Advertising

Learn rules and requirements for advertising therapeutic goods.

Unique Device Identification

Understand and apply Unique Device Identification (UDI) requirements.

Product types