Malaysia Takes Global Lead In Medical Device Regulatory Reliance

KUALA LUMPUR, July 17 (Bernama) -- Malaysia has made historic advancement in international regulatory collaboration with the launch of the Medical Device Regulatory Reliance Programme between the country and China.

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.

“This arrangement reduces regulatory duplication, accelerates market access, and improves patient access to quality healthcare technologies.

"It also strengthens Malaysia’s role as a regional regulatory hub and enhances global investor confidence in the country’s regulatory ecosystem,” he said in a statement today. 

Muralitharan said the programme was announced during the Healthcare Information and Management Systems Society Asia-Pacific (HIMSS APAC) Health Conference & Exhibition 2025, being held here from yesterday to tomorrow (July 16 to 18), following the signing of a memorandum of understanding between MDA and China’s National Medical Products Administration (NMPA) in November 2023.

Muralitharan noted that the Health Ministry and MDA welcome industry participation in the historic initiative, and stakeholders are encouraged to engage directly with MDA for consultation.

The programme, which will officially commence on July 30, reinforces Malaysia’s commitment to future-ready, efficient, and transparent healthcare regulation that benefits both patients and the global health industry.

-- BERNAMA