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Labelling and advertising for in vitro diagnostic devices

Information on how to make sure your in vitro diagnostic devices (IVDs) meet labelling, packaging, and advertising standards. 

When labelling and advertising in vitro diagnostic (IVD) medical devices, you must follow regulations. The labelling and advertising must be clear, accurate and not misleading. 
   

Labels and packaging need to include information about:  

  • the intended use

  • instructions

  • warnings

  • information to ensure accurate use of the device.

 
Labelling and packaging must also comply with the Essential Principles and Advertising Code.  
  

Advertising must be truthful and supported by evidence. It must not overstate the benefits, make unapproved claims or suggest our endorsement.   
  

We check compliance to help protect users and patients and build trust in your device. 
 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. 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.

Unique Device Identification

Understand and apply Unique Device Identification (UDI) requirements.

Product types