Australia – TGA requires Declaration of Conformity in ARTG applications for Class 1 IVDs

Australia’s Therapeutics Goods Administration (TGA) published a noteworthy regulatory update, Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures—Class 1 IVD Medical Devices) Determination 2020. New in this amendment, effective as of December 4, is the requirement to​ include the manufacturer’s Declaration of Conformity (DoC) in the Australian Register of Therapeutic Goods (ARTG) application for all Class 1 IVDs…