Kuala lumpur: Malaysia has made historic advancement in international regulatory collaboration with the launch of the Medical Device Regulatory Reliance Programme between the country and China.

According to BERNAMA News Agency, Medical Device Authority Malaysia (MDA) chief executive Dr. P. Muralitharan stated that 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. The programme enables both countries to recognize each other’s regulatory decisions for pre-market approvals, with Malaysian in vitro diagnostic (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,” Muralitharan said in a statement. “It also strengthens Malaysia’s role as a regional regulatory hub and enhances global investor confidence in the country’s regulatory ecosystem.”

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

He 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.