Malaysia Shifting Towards Risk-Based Medical Device Regulation - Dzulkefly

KUALA LUMPUR, Aug 28 (Bernama) -- Malaysia is shifting decisively towards a risk-based medical-device regulatory model to accelerate responsible innovation without compromising patient safety.

Malaysian Health Minister Dr Dzulkefly Ahmad said the approach would streamline regulatory processes for established products while allowing expertise and resources to focus on high-risk and groundbreaking innovations.

“We are shifting decisively towards a risk-based regulatory model by streamlining processes for established products.

“We maintain rigorous safety standards while freeing up regulatory expertise to focus on high-risk, groundbreaking innovations,” he said in his remarks at the closing ceremony of the International Medical Device Exhibition and Conference (IMDEC) 2026 here on Friday.

Dzulkefly pointed out that Malaysia was also strengthening international regulatory reliance and strategic partnerships to facilitate responsible market access.

“Regulation should never be an obstacle to care, but a trusted bridge to responsible market access,” he said.

The minister said a progressive regulatory system must support home-grown innovation from its earliest stages, with Malaysia strengthening the link between academic research and commercialisation through its Innovative Medical Device Pathway.

“We want to ensure that promising ideas developed in our universities and research centres do not remain trapped in laboratories,” he said.

Dzulkefly said a seamless “lab-to-bedside” innovation framework was being established to provide early regulatory guidance and strengthen public-private partnerships, enabling locally developed inventions to be translated into technologies that benefit patients.

He noted that said the newly established Medical Device Authority Centre of Excellence would bring together regulators, academics, researchers and industry players to develop specialised competencies, encourage knowledge exchange and nurture regulatory talent.

“Our shared responsibility is to ensure that innovation moves forward hand in hand with patient safety, quality, public confidence and trust,” he added.

Held from Aug 26 to 28, IMDEC 2026 brought together more than 160 exhibitors and over 50 regional and international speakers in medical-device regulation, innovation and healthcare transformation.

-- BERNAMA