Michelle McNiven

Michelle McNiven is currently the director of the In Vitro Diagnostic Medical Device (IVD) Reforms Section within the Medical Devices Branch, Therapeutic Goods Administration (TGA), Department of Health, Australia. She has a MAppSc in medical laboratory science and prior to commencing work with the TGA was the Chief Scientist, Molecular Pathology Laboratory, ACT Pathology, Canberra Hospital, Australia. Michelle joined the TGA in 2011 as an IVD medical device evaluator before shifting roles to manage the introduction of the IVD regulatory framework in Australia for both commercially supplied IVDs and laboratory developed tests (in-house IVDs). Her Section within the TGA is currently responsible for the approval of IVDs for supply in Australia; management of the in-house IVD regulatory requirements; and progressing further regulatory reforms related to IVDs. Michelle is also technical assessor for the National Association of Testing Authorities for the purpose of accreditation of Australian laboratories that develop in-house IVDs and represents the TGA on several local standards committees. She has previously participated as a technical consultant in the development of the WHO prequalification requirements for IVDs to detect G6PD deficiency