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Australia and European Union mutual recognition virtually complete

This article was originally published in Clinica

Executive Summary

Agreement on mutual recognition of conformity assessment between Australia and the EU "is virtually complete", according to the Australian Therapeutic Device Bulletin. The agreement will cover all devices subject to the EU Active Implantable Medical Device and Medical Device Directives and all devices covered by the Therapeutic Goods Act in Australia, apart from radioactive substances, some materials of animal origin, a number of devices containing pharmaceutical substances and products previously banned in any country.

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