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Regulatory requirements for in-house IVDs

Version 2.2, September 2018

11 September 2018

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Version history

Version Description of change Author Effective date
V1.0 Original publication IVD Section January 2012
V2.0 Updated to reflect recent amendments to regulatory requirements. IVD Section March 2016
V2.1 Updated to remove transition information which ended July 2017 and include more information about what constitutes an in-house IVD IVD Section May 2018
V2.2 Included link to MoU and updated broken links for NPAAC publication and TGA fees and charges IVD Section September 2018

Book pagination