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The Medical Device Control Office is to launch a trial program for expediting the approval of certain classes of medical devices.
The Chinese medtech regulatory system was a key theme at the MedTech Summit in June, where regional specialists gave updates on registration timelines and electronic submissions, and signaled how the world’s biggest market-in-waiting is speeding up its regulatory improvements in a bid to become more open and less forbidding for overseas entrants.
Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.
There has been no recent impact assessment as to how business will be affected by the text of the IVD Regulation that was finally adopted. Consultant Robyn Meurant explains how industry will be paying a high price, and why many IVD companies could go under.
The medical device industry is eager to explore regulatory proposals to introduce Unique Device Identification (UDI) in Australia. However, when it comes to implementation of a system, medtech firms claim they should be given enough time to clear non-UDI-compliant products from their inventory in distribution channels.
The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on the international front, with the US, for one, wanting to see a three-year postponement. Is the European Commission right to remain stubbornly attached to its deadline?
Neuromodulation firm Nexstim has received regulatory clearance for its SmartFocus TMS system for treating major depressive disorder (MDD) in Australia.
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