Malaysia's Medical Device Authority (MDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) in Tokyo, marking a significant step toward regulatory alignment and closer collaboration between the two countries. The agreement lays the groundwork for more efficient medical device registration, enhanced information sharing, and improved post-market surveillance frameworks. Manufacturers operating in both markets could benefit from greater regulatory predictability and streamlined market access as the partnership develops.
Malaysia's Medical Device Authority (MDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) on 10 June 2026 in Tokyo. The agreement aims to support regulatory alignment, harmonisation, and closer cooperation between both authorities. No immediate regulatory changes have been announced. However, the MoC creates a foundation for future improvements in regulatory efficiency and market access in Japan and Malaysia.
The agreement establishes cooperation in several areas:
Japan will assist Malaysia in identifying suppliers of finished medical devices facing shortages to support supply chain resilience and continued patient access to essential technologies. Japan also expressed support for Malaysia's bid to become an APEC Center of Excellence (CoE), reinforcing Malaysia's growing role within the regional medical device regulatory landscape.
A major focus of the discussions was strengthening cooperation in medical device evaluation, registration, and post-market surveillance. Potential benefits for manufacturers include:
The discussions also included a commitment to review Certificate of Free Sale (CFS) requirements, which may help reduce administrative burdens and improve the efficiency of registration submissions across multiple markets.
The partnership could provide Malaysian manufacturers greater exposure to Japan's globally recognised regulatory framework, which will support expansion into international markets.
Japan expressed in-principle support for a future Memorandum of Cooperation between the Global Harmonization Working Party (GHWP) and the International Medical Device Regulators Forum (IMDRF).
Greater alignment between these organisations could support:
During the visit, MDA also engaged with Kaneka Medix Corporation and SPHinX Inc., both of which are exploring opportunities to introduce innovative technologies into Malaysia.
Kaneka Medix specialises in neurovascular devices for minimally invasive treatments, while SPHinX is developing smart polymer-based diagnostic technologies designed to improve disease detection accuracy. These technologies have the potential to strengthen Malaysia's treatment and diagnostic capabilities while creating opportunities for collaboration with local industry stakeholders.
These developments align with Malaysia's broader efforts under the National Industrial Master Plan 2030 (NIMP 2030) and its commitment to adopting international best practices, including the World Health Organization's Good Reliance Practices (GRelP).
For further information, refer to the Official MDA Announcement on Malaysia–Japan Medical Device Cooperation.
Learn more about MDA Malaysia Medical Device Registration and PMDA Japan Medical Device Registration & Approval.
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