Supply a medical device
Guidance on legally supplying medical devices in, and exporting them from, Australia.
Loading...
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.
-
GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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
-
GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
-
PageOverview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework.
-
PageWe will recognise the extended transition for the European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR)
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.