Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (IVDs) (Fourth Edition 2018)

This is a National Pathology Accreditation Advisory Council publication which is managed by the Australian Government Department of Health relating to the development and use of In-House In Vitro Diagnostic Medical Devices

Page last updated: 27 June 2018

The Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (IVDs) (Fourth Edition 2018) outlines the principles and assessment criteria by which in-house IVDs must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia.

The revised Requirements have been reviewed to reflect the current regulatory requirements for in house IVDs and provide clarification of the levels of evidence for scientific validity.

This document comes into effect on 1 December 2018.

The Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (IVDs) (Fourth Edition 2018) (PDF 375 KB)
The Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (IVDs) (Fourth Edition 2018) (Word 134 KB)

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