Malaysia-Singapore 2025 MOU on Medical Device Regulatory Reliance

Malaysia’s Medical Device Authority (MDA) and Singapore’s Health Sciences Authority (HSA) signed a 2025 Memorandum of Understanding (MOU) to launch a Medical Device Regulatory Reliance Pilot Programme. Signed at the 14th ASEAN Medical Device Committee (AMDC) Meeting in Siem Reap, Cambodia on 22 August 2025, this initiative aims to streamline Malaysia medical device registration and accelerate Singapore medical device approvals, reducing duplication, shortening timelines, and enhancing patient access to safe, innovative medical technologies across ASEAN.

Key Highlights of the 2025 MOU

• Six-month regulatory reliance pilot from 1 Sept 2025 – 28 Feb 2026

• Applies to Class B, C, and D devices

• Faster approvals through reliance on each other’s regulatory assessments

• Reduced duplications of reviews, cutting costs and time-to-market

• Earlier patient access to safe, innovative, and high-quality medical technologies

What the Industry Can Expect

During the pilot, MDA and HSA will:

• Test streamlined regulatory pathways

• Refine and establish clear SOPs for the reliance pathway

• Validate shortened processing timelines

• Gather industry feedback to shape a scalable long-term reliance framework

Benefits for Medical Device Manufacturers

In Malaysia:

• Devices already approved by HSA may undergo a verification (abridged) route through MDA’s Conformity Assessment Body (CAB).

• Review time reduced to 30 working days (vs. 60 days under full conformity assessment).

• Devices then registered within another 30 working days.

In Singapore:

• Devices registered with MDA benefit from an abridged review pathway.

• Expected to achieve up to 30% shorter review times for Class B, C, and D devices.

Why This Matters for ASEAN Market Access

The pilot reflects a new era of regulatory convergence and industry collaboration between Malaysia and Singapore. It:

• Streamlines approval processes and reduces costs

• Strengthens technical confidence in regulatory systems

• Supports regional economic integration under the ASEAN Medical Device Directive (AMDD)

• Expands opportunities for medical device companies to diversify markets and drive economic growth

Statements from Regulators

Adjunct Professor (Dr) Raymond Chua, CEO of HSA:

“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.”

Dr. Muralitharan Paramasua, CEO of MDA:

“Malaysia and Singapore recognise 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.”

Next Steps for Stakeholders

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

Contacts for stakeholders

• Medical Device Authority (MDA), Malaysia – registration@mda.gov.my

• Health Sciences Authority (HSA), Singapore – HSA official site

Learn more

• Pure Global – MDA Malaysia Medical Device Registration

• Pure Global – HSA Singapore Medical Device Registration

External links

• Official HSA press release: HSA & MDA sign MOU (22 Aug 2025)

• Download the official joint statement PDF here

Malaysia’s MDA and Singapore’s HSA signed a 2025 MOU to launch a Medical Device Regulatory Reliance Pilot (Sept 2025–Feb 2026). The pilot streamlines Class B–D device approvals, with shorter timelines via reliance on each other’s regulatory reviews. Manufacturers benefit from reduced duplication and faster ASEAN market access, while patients gain earlier access to safe, innovative technologies. This initiative supports the ASEAN Medical Device Directive (AMDD) and may expand into a long-term reliance framework.

‍