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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.