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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PageLearn how to submit an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including requirements, processes, and regulatory considerations.
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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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GuidanceLearn how to change the sponsor of a therapeutic good in Australia, including requirements, process steps, and regulatory obligations for sponsors and manufacturers.
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
Product types