We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Supply a medical device
-
PageA step-by-step process for sponsors (official suppliers) to supply medical devices in, or export them from, Australia.
-
PageStep-by-step process for manufacturers to supply devices in, or export them from, Australia.
Vary, cancel or maintain an ARTG entry
-
PageHow to vary an Australian Register of Therapeutic Goods (ARTG) entry for your medical device.
-
FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
-
PageLearn how to submit a variation to Manufacturer Evidence
-
PageOverview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework.
Incidents and adverse events
-
PageIndustry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system.
-
PageProvides information about adverse events and incidents related to therapeutic goods used in Australia.
Breaches and non-compliance reporting
-
FormsUse this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products.
-
ServiceUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
Recalls
-
-
PageUnderstand how we work with sponsors and stakeholders to ensure that recall actions are successful, as well as how we categorise recall actions.