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.
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PageThe ARGMD will help you navigate the regulatory requirements for medical devices in Australia.
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GuidanceGuidance to understand if your medical device product should be in the Australian Register of Therapeutic Goods (ARTG).
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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PageMedical devices priority applicant determination notices and eligibility for priority review pathway.
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PageOur goal is to harmonise with other jurisdictions (and international standards where necessary).
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GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation about the application process and forms.
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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PageThis instrument is made under subsection 41FDB(2) of the Act.
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LegislationThis Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.
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GuidanceGuidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
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GuidanceThis guidance explains how overseas assessments can support our medical device certification and registration processes.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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PageUpdate to information about applying for assessment of a COVID-19 test for inclusion in the ARTG.
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PageThe ARGMD will help you navigate the regulatory requirements for medical devices in Australia.
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PageNew information about importing self-tests.
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
Global Medical Device Nomenclature
Access the correct GMDN terms for devices.
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PageFind out about Global Medical Device Nomenclature (GMDN) Terms, which are an international naming and grouping convention used to identify and consistently describe medical 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.
Product changes and variations
Access information to vary products and sponsorship.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.