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Delay to Australia and European Union mutual recognition

This article was originally published in Clinica

Executive Summary

The March election of a new government in Australia has made it difficult to predict when the proposed medical device mutual recognition agreement between Australia and the European Union will be implemented. The MRA was due to come into force on January 1st this year (see Clinica No 676, p 7). Agreement has now been reached on the technical content and the way is clear for the MRA to proceed, reports the Australian Therapeutic Device Bulletin. Officials are scheduled to meet in Brussels during May to initial the agreement. A number of changes to Australia's Therapeutic Goods Act will be required before the MRA can finally be implemented.

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