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Deadline for certain medical device reforms to be extended

Deadline for certain medical device reforms to be extended

07 Jul 2023

Regulatory amendments are underway and are expected to be in place this year. The extended deadlines would give manufacturers time to obtain an EU MDR certificate before the end of the EU MDR transition on 31 December 2028, and for sponsors to use the MDR certificate to apply to the TGA before 1 July 2029.

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