TGA
The Government recently agreed to extend the deadlines for several medical device reforms underway in Australia, because of the impact of the European Union Medical Device Regulations (EU MDR) transition.
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.
Visit the EU MDR transition extension page to read about the key dates and changes.
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