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.
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User guideStep by step guide to submitting a Custom-Made Medical Device (CMMD) notification.
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PageSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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PageInformation for applicants on how to request and prepare for pre-submission meetings.
Fees and charges
Understand fees, exemptions and how to make payments.
Global Medical Device Nomenclature
Access the correct GMDN terms for devices.
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GuidanceGuidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.