Malaysia Takes Global Lead In Medical Device Regulatory Reliance
Medical Device Authority Malaysia (MDA) chief executive Dr P. Muralitharan said the initiative represents a strategic breakthrough in accelerating access to safe and innovative medical technologies while reinforcing Malaysia's position as a global regulatory leader.
He said the programme enables both countries to recognise each other's regulatory decisions for pre-market approvals, with Malaysian IVD devices now qualifying for China's Green Channel, while Chinese devices may use Malaysia's Verification Pathway, reducing approval timelines to 60 and 30 working days, respectively.
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