To legally supply a system or procedure pack, it must be included in the Australian Register of Therapeutic Goods (ARTG). We regulate these packs as a single medical device.
You can apply for ARTG entry through our Business Services portal. We assess your pack for safety, performance and quality. Fees apply for application, evaluation and annual registration.
This stage ensures your pack complies with regulatory requirements and is 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 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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GuidanceGuidance to understand if your medical device product should be in the Australian Register of Therapeutic Goods (ARTG).
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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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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
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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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.