Notice of Commencement: The amended Requirements for the In-House In Vitro Diagnostic Medical Devices (Fifth Edition, 2025) now includes a standard for Companion Diagnostics. This edition will replace the current edition on 20 April 2026. Until that date, the existing requirements remain in force.

The Australian Commission on Safety and Quality in Health Care, in consultation with the National Pathology Accreditation Advisory Council (NPAAC), advises of an amendment to the language in Action 1.01 of the Requirements for Medical Testing for Human Genetic Variation. The wording of Action 1.01 has been amended to clarify intent and improve...

The Australian Commission on Safety and Quality in Health Care, in consultation with the National Pathology Accreditation Advisory Council (NPAAC), advises of an amendment to the confirmatory testing for HIV and HCV of the Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV). The amendment is to...

The Commission, in consultation with the National Pathology Accreditation Advisory Council (NPAAC), advises of an amendment to the confirmatory testing for HIV and HCV of the Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV).

The Commission, in consultation with the National Pathology Accreditation Advisory Council (NPAAC), advises of an amendment to the language in Action 1.01 of the Requirements for Medical Testing for Human Genetic Variation.

The Commission, in consultation with the National Pathology Accreditation Advisory Council (NPAAC), advises of an amendment to the Requirements for the Development and Use of In-House In Vitro Diagnostic (IVD) Medical Devices.

The Commission is seeking your feedback on the draft Point of Care Testing (POCT) Standard, which closes on 12 December 2025.