In a landmark collaboration, 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 accelerate patient access to innovative medical technologies. The agreement, announced on 22 August 2025 during the 14th ASEAN Medical Device Committee (AMDC) Meeting in Siem Reap, Cambodia, marks the official launch of a 6-month Medical Device Regulatory Reliance Pilot Programme running from 1 September 2025 to 28 February 2026.

A Step Forward for Faster Approvals

The pilot aims to streamline the registration process for Class B, C, and D medical devices by enabling each country to rely on one another’s regulatory assessments and approvals. This strategic initiative is expected to:

Reduce duplication of reviews, saving time and costs for manufacturers.
Accelerate approvals for safe, high-quality, and innovative medical technologies.
Provide earlier patient access to cutting-edge medical devices.

What the Industry Can Expect

As part of the pilot, MDA and HSA will jointly develop streamlined pathways and test shortened processing timelines. Device manufacturers can look forward to:

In Malaysia: Devices already registered with HSA can undergo an abridged verification route via MDA’s Conformity Assessment Body (CAB). Review times are expected to drop to 30 working days, compared to the standard 60 days, with registration completed within another 30 days.
In Singapore: Devices registered with MDA will benefit from an abridged review pathway, with up to 30% shorter review times across all Class B to D devices.

Voices from the Regulators

“This MOU marks a significant milestone in 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.”
— Adjunct Professor (Dr) Raymond Chua, CEO, HSA

“Malaysia and Singapore recognise the importance of exploring new markets to create greater opportunities for medical device industry players. This strategic partnership seeks to diversify market opportunities, strengthen technical confidence, and enhance patient access to advanced medical technologies.”
— Dr. Muralitharan Paramasua, CEO, MDA

Looking Ahead

The pilot will serve as a foundation for broader cross-border regulatory collaborations in the future. At the end of the six months, MDA and HSA will evaluate the programme’s success and explore full-scale implementation of the Medical Device Regulatory Reliance Programme to further harmonise regional medical device approvals.

Image: Conceptual illustration generated by AI via ChatGPT for The Wellness Insider.