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Application and market authorisation for personalised medical devices

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

To supply a personalised device in Australia, you may need to apply to include it in the Australian Register of Therapeutic Goods (ARTG).   
 

  • Adaptable medical devices require ARTG inclusion. Apply through our Business Services portal. We assess your device to ensure it meets safety, performance and quality standards. Evaluation and application fees apply.  

  •  Patient-matched medical devices are exempt from ARTG inclusion until 1 July 2029.  

  • Custom-made medical devices are exempt from ARTG inclusion but still have other obligations.   
     

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.

Application pathways and processes

Find application routes to market approval.

Fees and charges

Understand fees, exemptions and how to make payments.

Global Medical Device Nomenclature

Access the correct GMDN terms for devices.

Product types