In Vitro Diagnostic medical devices (IVDs)
Information on In Vitro Diagnostic medical devices (IVDs).
Information on In Vitro Diagnostic medical devices (IVDs).
Latest articles
- New guidance published on manufacturer evidence for IVD medical devicesTo help sponsors and manufacturers transition to new manufacturer evidence.
- 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).
Latest publications
- ACMD meeting statement, Meeting 74, 10 August 2023Read the meeting statement from 10 August 2023 meeting of the Advisory Committee on Medical Devices (ACMD).
- ACMD meeting statement, Meeting 73, 8 June 2023Read the meeting statement from 8 June 2023 meeting of the Advisory Committee on Medical Devices (ACMD).
- ACMD meeting statement, Meeting 72, 13 April 2023Meeting statement from the Advisory Committee on Medical Devices (ACMD), 13 April 2023.