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Australia consults on third-party conformity assessment

This article was originally published in SRA

Executive Summary

Australia’s Therapeutic Goods Administration may begin allowing third-party conformity assessment bodies to examine and certify the quality systems of local medical device manufacturers1. To that end, it has released a consultation document that outlines the principal issues to be considered, the most important of which is determining an appropriate balance in the use of CABs to ensure the timely availability of safe and effective medical devices2. Comments are due by 27 March.

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