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Australia's TGA proposes to "upclassify" joint implants

This article was originally published in SRA

Executive Summary

Australia’s Therapeutic Goods Administration is planning to raise the level of regulatory oversight for certain joint replacement implants by proposing to reclassify the devices from Class IIb (moderate/high risk) to Class III (highest risk)1,2. A similar proposal several years ago failed to make it into law3.

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