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Australia's new medical device rules open way to full EU MRA (mutual recognition agreement)

This article was originally published in Clinica

Executive Summary

After a series of delays Australia at last implemented its new medical device regulatory system on October 4. The new law removes the obstacles to the EU implementing for its part the mutual recognition agreement (MRA) with Australia. The MRA is already in operation in Australia, where the TGA, the Australian regulatory authority, has issued several certificates to the EU regulatory system. But the EU has said that it would not operate the system until the new Australian medical device law is voted and implemented and in harmony with the EU requirements.

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