The Medical Device Authority (MDA) of Malaysia and Health Sciences Authority (HSA) of Singapore have signed a Memorandum of Understanding (MOU) to deepen regulatory cooperation and have officially launched a six-month pilot of the Medical Device Regulatory Reliance Program as part of the MOU.

This strategic MOU reinforces a new era of regulatory convergence and industry collaboration between Malaysia and Singapore. A pilot program running from Sept. 1 to Feb. 28, 2026, will streamline the Class B, C, and D medical device registration, delivering:

• Faster approvals through reliance on each other’s regulatory assessment and approvals;
• Reduced duplications of reviews, cutting costs and time-to-market; and
• Earlier patient access to safe, innovative and high-quality medical technologies.

“This MOU marks a significant milestone in the advancement of our partnership with Malaysia MDA,” HSA CEO and Adjunct Professor (Dr.) Raymond Chua said. “By building trust in each other’s regulatory systems, we can support the medical device industry with more efficient processes while ensuring patients gain faster access to safe and high quality medical devices. We look forward to a fruitful partnership and hope this pilot paves the way for broader cross-border regulatory collaborations.”

Pilot Program Expectations

Both regulatory agencies will work closely through the pilot program to test streamlined pathways, refine and establish clear standard operating procedures for the reliance pathway, validate shortened processing timelines, and gather stakeholders’ feedback so an effective and scalable regulatory reliance program can be built after the pilot.

Medical Device Registration Certificate Holders participating in the pilot can expect reduced review times for medical device registration in both countries:

1. In Malaysia: Devices registered with HSA may undergo a verification route (abridged review pathway) through MDA’s Conformity Assessment Body (CAB). The review is expected to take 30 working days, compared to 60 working days under the full conformity assessment route. The device will then be registered within 30 working days.
2. In Singapore: Devices registered with MDA will benefit from an abridged review pathway, achieving up to 30% shorter review times across all Class B to D medical devices.

“Malaysia and Singapore recognize the importance of exploring new markets to create greater opportunities for medical device industry players to expand their businesses. With strong growth potential, the medical device sector has made a significant contribution to national income and economic development, while enhancing patient access to advanced medical technologies,” MDA Chief Executive Dr. Muralitharan Paramasua stated. “This strategic partnership seeks to diversify market opportunities, strengthen technical confidence in the medical device regulatory system, and stands as a testament to the close and enduring relationship between Malaysia and Singapore.”

This MOU reflects the desire of both countries to work together to advance regional economic integration. When the pilot is complete, MDA and HSA will jointly evaluate the outcomes and consider full scale implementation of the regulatory reliance program.