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Conformity Assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles.
From 28 July 2021, devices that were previously described under regulation 4.1 (those that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs) no longer require mandatory TGA Conformity Assessment certification.