The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore have signed a Memorandum of Understanding (MOU) to deepen regulatory cooperation and officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme.

The MOU was signed during the 14th ASEAN Medical Device Committee (AMDC) Meeting held in Siem Reap, Cambodia, on August 22, 2025.  

Running from September 1, 2025, to February 28, 2026, the pilot programme will streamline the registration of Class B, C, and D medical devices. It aims to deliver 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.  

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

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.

In Singapore, devices registered with MDA will benefit from an abridged review pathway, achieving up to 30 percent shorter review times across all Class B to D medical devices.

“This MOU marks a significant milestone in the advancement of our partnership with Malaysia MDA. 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,” said HSA CEO Adjunct Professor (Dr) Raymond Chua.

Dr. Muralitharan Paramasua, Chief Executive, MDA, highlighted that both countries recognised 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. 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,” he added.

At the conclusion of the pilot, MDA and HSA will jointly evaluate the outcomes and consider full-scale implementation of the regulatory reliance programme.