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BioWorld - Saturday, April 18, 2026
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Home » TGA asked to hold off on device reclassification pending implementation of EU's MDR
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TGA asked to hold off on device reclassification pending implementation of EU's MDR

Nov. 13, 2019
By Tamra Sami
Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.
Medical technology Asia-Pacific Australia TGA

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