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Application and market authorisation for in vitro diagnostic devices

Information about how to submit an application and our evaluation processes and application fees.

To legally supply an in vitro diagnostic (IVD) medical device in Australia, it must meet safety, quality, and performance standards and be included in the Australian Register of Therapeutic Goods (ARTG), unless exempt. You need to apply through our Business Services portal.   
  

Your application may be selected for application audit. This is consistent with the medical device application audit framework.  
 

This involves reviewing:   

  • conformity assessment evidence

  • device technical files

  • any supporting evidence that it meets regulatory requirements.

 
Application and audit assessment fees apply. Assessment depth depends on the IVD's risk classification and supporting conformity assessment evidence.  
  

If approved, your IVD will be included on the ARTG and authorised for supply in Australia.  
 

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.

Application pathways and processes

Find application routes to market approval.

Pre-submission planning

Access requirements for pre-submission planning and meetings.

Global Medical Device Nomenclature

Access the correct GMDN terms for devices.

Product changes and variations

Access information to vary products and sponsorship.

Product types