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Conformity Assessment On Way Out For Many Australian Devices

This article was originally published in PharmAsia News

Executive Summary

The Australian government will soon amend its regulations to allow most local medical device manufacturers to rely on conformity assessments by European notified bodies. The change is welcome news for the industry, which has long been pushing for a change to the current scenario under which it is mandatory for products to undergo conformity assessment by the Therapeutic Goods Administration.

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