Kuala lumpur: Malaysia is shifting decisively towards a risk-based medical-device regulatory model to accelerate responsible innovation without compromising patient safety. Health Minister Datuk Seri Dr Dzulkefly Ahmad emphasized this strategic shift during his remarks at the closing ceremony of the International Medical Device Exhibition and Conference (IMDEC) 2026.
According to BERNAMA News Agency, Dr Dzulkefly outlined that the new approach intends to streamline regulatory processes for established products while concentrating expertise and resources on high-risk and innovative medical technologies. The Health Minister articulated the need for rigorous safety standards while promoting regulatory flexibility, ensuring that regulatory bodies can focus on groundbreaking innovations without being bogged down by established products.
Moreover, Dr Dzulkefly highlighted Malaysia's commitment to strengthening international regulatory reliance and forming strategic partnerships to facilitate responsible market access. He stressed that regulation should act as a bridge to responsible market access rather than an obstacle to healthcare delivery.
The minister also discussed the importance of supporting home-grown innovation. He mentioned Malaysia's efforts to strengthen the link between academic research and commercialization through its Innovative Medical Device Pathway. This initiative aims to ensure that innovative ideas developed in universities and research centers can transition smoothly from laboratories to practical applications, benefiting patients directly.
Dr Dzulkefly announced the establishment of a seamless 'lab-to-bedside' innovation framework intended to provide early regulatory guidance and foster public-private partnerships. This effort will enable locally developed inventions to be translated into viable medical technologies. Furthermore, the newly established Medical Device Authority Centre of Excellence will serve as a collaborative hub for regulators, academics, researchers, and industry professionals to develop specialized competencies and nurture regulatory talent.
The minister concluded by emphasizing the shared responsibility of ensuring that innovation progresses alongside patient safety, quality, and public confidence. The IMDEC 2026, held from August 26 to 28, gathered over 160 exhibitors and more than 50 regional and international speakers, focusing on medical-device regulation, innovation, and healthcare transformation.