Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices -Third Edition 2014

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: 02 June 2014

The Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Third Edition 2014) outlines the principles and assessment criteria by which in house IVD’s must be designed, developed, produced and monitored for use by medical laboratories in Australia.

This document has a proposed date of effect of 1 June 2014

PDF Version: Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices -Third Edition 2014 (PDF 200 KB)
Word version: Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices -Third Edition 2014 (Word 129 KB)