The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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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PageStep-by-step process for manufacturers to supply devices in, or export them from, Australia.
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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
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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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PageLearn how to submit a variation to Manufacturer Evidence
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GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
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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)
Breaches and non-compliance reporting
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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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ServiceUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.