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.
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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Reference materialIf sponsorship is transferred to you, you need to notify the TGA
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PageOverview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework.
Incidents and adverse events
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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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PageProvides information about adverse events and incidents related to therapeutic goods used in Australia.
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.
Recalls
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PageUnderstand how we work with sponsors and stakeholders to ensure that recall actions are successful, as well as how we categorise recall actions.