Amendment to the Requirements for In-House In Vitro Diagnostic Medical Devices

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.

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The amendment strengthens the safety and quality requirements of companion diagnostics (CDx) in the development and use of in-house IVDs by introducing:

  • a new CDx framework
  • actions for validation when CDx is used for treatment selection
  • actions for equivalence with clinical trial assays.

The amendment is enforceable from 20 April 2026. 

The updated version of the Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition, 2025) is available on the Commission’s website.

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Important note: In Vitro Diagnostic Device Software Requirements are currently being developed and will be shared when they become available.

More information

Visit safetyandquality.gov.au/pathology or email pathology@safetyandquality.gov.au

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