The Medical Device Authority (MDA) of Malaysia and the Ministry of Health, Labour and Welfare (MHLW) of Japan signed a Memorandum of Cooperation (MoC) on 10 June 2026 in Tokyo to strengthen regulatory cooperation in the medical device sector.
Executed during the official visit of the Prime Minister of Malaysia to Japan, the MoC aims to enhance information exchange, scientific collaboration, personnel training, and regulatory alignment between both nations.
Read the full press release here:
https://www.facebook.com/photo/?fbid=1454176843406777&set=pb.100064434259645.-2207520000
Purpose of the MoC
To strengthen bilateral cooperation between Malaysia and Japan in medical device regulation.
To support information exchange, scientific collaboration, personnel training, and regulatory alignment between MDA Malaysia and MHLW Japan.
Scope of Cooperation
The MoC focuses on cooperation in the medical device sector, including product evaluation, registration, post-market surveillance, regulatory harmonization, and access to safe, effective, and high-quality medical devices.
Key Highlights
- Malaysia and Japan strengthened bilateral cooperation in medical device regulation, focusing on expedited product evaluation, registration, and post-market surveillance.
- Japan expressed formal support for the proposed MoC between GHWP and IMDRF to advance global regulatory harmonization.
- Both parties agreed to review Certificate of Free Sale (CFS) requirements to facilitate trade.
- Japan supported Malaysia’s bid to become an APEC Center of Excellence (CoE).
- Japan agreed to assist Malaysia in identifying reliable suppliers for finished medical devices experiencing local shortages.
- MDA engaged with Kaneka Medix Corporation and SPHinX Inc. to explore bringing innovative neurovascular and diagnostic technologies into Malaysia.
- The collaboration is expected to boost the competitiveness of Malaysian medical device manufacturers and support expansion into international markets.
- This initiative aligns with Malaysia’s National Industrial Master Plan 2030 and WHO Good Reliance Practices (GReIP), improving access to safe, effective, and high-quality medical devices.
Implications to Clients
The MoC signals closer regulatory alignment between Malaysia and Japan, paving the way for streamlined evaluation and registration processes.
Japan’s support for GHWP and IMDRF collaboration may drive greater international convergence of regulatory expectations.
The discussions with Japanese companies on advanced neurovascular and diagnostic technologies indicate MDA’s interest in facilitating innovative medical devices in Malaysia.
Clients should monitor future developments arising from this cooperation, particularly any updates relating to reliance pathways, CFS requirements, product evaluation, post-market surveillance, and opportunities for advanced medical device technologies in the Malaysian market.
Effective Date
10 June 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.