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In Vitro Diagnostic medical devices (IVDs)
Information on In Vitro Diagnostic medical devices (IVDs).
Information on In Vitro Diagnostic medical devices (IVDs).
Latest articles
- Phase out of ISO 13485 certificates for IVD medical devicesTransition period for accepting ISO 13485 ends 26 May 2023.
- EU MDR transition extensionThe TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
- Therapeutic Goods (Medical Devices - Application Form for Priority Applicant Determinations) Approval 2020New legislative instrument
Latest publications
- ACMD meeting statement, Meeting 72, 13 April 2023Meeting statement from the Advisory Committee on Medical Devices (ACMD), 13 April 2023.
- Clinical performance requirements and risk mitigation strategies for HIV testsGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
- ACMD meeting statement, Meeting 71, 9 February 2023Meeting statement from the Advisory Committee on Medical Devices (ACMD), 9 February 2023.