Malaysia Strengthens Global Leadership in Medical Devices

Malaysia has achieved a significant milestone in global medical device regulation. The Medical Device Authority (MDA), a ministry of the Ministry of Health Malaysia, has announced that its Chief Executive Officer, Dr Muralitharan Paramasua, has been elected as the Chair of the Global Harmonisation Working Party (GHWP) for the 2026–2028 term.

The appointment was confirmed during the 29th GHWP Annual Meeting, held from December 1 to 4, 2025, in Bangkok, Thailand. Dr Muralitharan received broad support from GHWP’s member economies and international organizations, showcasing strong confidence in Malaysia’s regulatory leadership.

GHWP: A Key Platform for Global Regulatory Harmonisation Organisation

GHWP is an international organization comprising 38 member countries, dedicated to promoting alignment and harmonisation of medical device regulations. Since joining GHWP in 1996, Malaysia has been an active contributor, participating in technical committees and working groups that shape international regulatory guidelines.

This election represents a recognition of Malaysia’s expertise, progress, and long-standing commitment to regulatory excellence.

A Recognition of Malaysia’s Regulatory Strength

Dr Muralitharan brings extensive experience as a regulator, with involvement across major global platforms: GHWP, ASEAN, APEC, and IMDRF. Support from countries such as China, Japan, Korea, Saudi Arabia, Thailand, Singapore, Indonesia, Uzbekistan, Egypt, and organisations including the World Health Organisation (WHO) further underscores Malaysia’s rising influence in the global regulatory ecosystem.

Four Key Strategic Priorities Under Malaysia’s GHWP Leadership

Dr Muralitharan outlined four core initiatives that will guide GHWP over the next three years:

1. Enhancing GHWP Governance through Regional Offices

As medical device innovation accelerates, GHWP must operate with agility. Establishing regional offices will help decentralise responsibilities, strengthen governance, and ensure more effective engagement with diverse member economies.

This model allows GHWP to be closer to its members, enabling tailored regulatory support.

2. Strengthening Capacity Building and Training

To achieve true regulatory harmonisation, member countries need strong regulatory capabilities. GHWP plans to establish a Regional Academy, envisioned as a center of excellence for developing world-class regulatory professionals.

This Academy will support broader adoption of GHWP guidelines and help countries progress systematically toward regulatory convergence.

3. Expanding Membership and Increasing Inclusivity

GHWP aims to welcome more members and foster an inclusive environment where regulators and industry stakeholders regardless of region,feel equally represented. Moving beyond traditional “East vs. West” distinctions, GHWP seeks a unified global approach to regulation.

4. Driving Foundational Harmonisation Work

GHWP will accelerate efforts in core regulatory areas, including:

• Medical device nomenclature

• Reliance and recognition frameworks

• Product classification

• Standards and technical guidelines

Harmonisation in these foundational elements will support faster regulatory reviews and strengthen cross-border collaboration among member economies.

What This Means for Malaysia

Malaysia’s new leadership role will bring several national benefits, including:

✔ Strengthening Malaysia’s position as a regional and global regulatory leader

✔ Greater influence in shaping international medical device policies and standards

✔ Improved global market access for Malaysian manufacturers

✔ Increased investor confidence and industry collaborations

✔ A more robust and globally aligned regulatory system within Malaysia

This appointment marks a historic moment for Malaysia and a significant recognition of the Medical Device Authority’s continuous efforts to enhance regulatory excellence.

Conclusion

Dr Muralitharan’s appointment as GHWP Chair is a proud milestone for Malaysia and a strong signal to the global medtech community. With a clear strategic vision, Malaysia is set to play a pivotal role in advancing global harmonisation, improving regulatory capacity, and supporting innovation in the medical device sector.

As GHWP steps into a new chapter of leadership, the next three years promise meaningful progress toward a more harmonised, transparent, and globally connected regulatory ecosystem.