The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The TGA recently implemented an EU MDR transition strategy for Australian medical device sponsors and stakeholders. More recently, the EU extended the transition, prompting the TGA to review its strategy, and to review the impact on reclassification reforms underway in Australia.
Visit EU MDR transition extension to read about the key dates and changes.