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Find guidance on how to legally supply medical devices in Australia or export them overseas.
Supply a medical device
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PageA step-by-step process for sponsors (official suppliers) to supply medical devices in, or export them from, Australia.
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PageFollow the steps for manufacturers to supply a medical device in Australia, including meeting regulatory requirements and applying for inclusion in the ARTG.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
Vary, cancel or maintain an ARTG entry
Manage your medical device entries in the ARTG.
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PageHow to vary an Australian Register of Therapeutic Goods (ARTG) entry for your medical device.
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
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PageMedical device and in vitro diagnostic (IVD) applications require a Manufacturer's Evidence application.
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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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PageOverview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework.
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PageWe will recognise the extended transition for the European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR).
Incidents and adverse events
Report and manage safety concerns for medical devices.
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PageIndustry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system.
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PageAll adverse events reported to us are added to this searchable database.
Breaches and non-compliance reporting
Report concerns about therapeutic goods and practices.
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FormsUse this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products.
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TransactionUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
Recalls
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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