Malaysia-Singapore Reliance Pilot
The HSA and Malaysia’s Medical Device Authority (MDA) signed an MoU in August 2025 and ran a pilot from September 1, 2025 through February 28, 2026. The pilot covers Class B, C, and D medical devices and works in both directions. A device already registered with the HSA moves through an abbreviated review at the MDA’s Conformity Assessment Body. This cuts the review from 60 working days to 30 working days, followed by a 30-day registration step. A device already registered with MDA receives an expedited review at HSA, which cuts review time by up to 30%.
The pilot produced at least 15 HSA-registered products approved by the MDA during the test period. Based on that result, the HSA and MDA moved the program into full implementation as the Medical Device Regulatory Reliance Program starting March 1, 2026. Malaysia had already run a similar reliance arrangement with China’s National Medical Products Administration (NMPA).
Renewed Collaboration with China
The HSA and China’s NMPA signed a renewed Memorandum of Understanding on May 11, 2026, in Beijing. The agreement expands a 2021 MoU and now covers chemical drugs, active pharmaceutical ingredients, biological products, traditional Chinese medicines, medical devices, cosmetics, and, as a new addition, cell, tissue, and gene therapy products.
The renewed MoU commits both agencies to exchange regulations, information, and best practices, run joint inspections of manufacturing facilities, build regulatory capacity through staff exchanges, and explore pilot schemes for innovative products. The HSA and NMPA have collaborated for more than 20 years, and the HSA has already approved roughly 35 medicines and more than 1,000 medical devices originating from China. The expanded scope into cell and gene therapy products signals where both agencies expect the next wave of device and combination-product submissions to originate.
Reliance Mechanisms with Japan
The HSA and Japan’s Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation on April 20, 2026, in Tokyo. The agreement centers on mutual reliance on Good Manufacturing Practice (GMP) certificates and inspection outcomes for manufacturers in both countries. It extends across the full product lifecycle – clinical trials, product review, registration, manufacturing, and post-market surveillance. The agreement covers medicines, cell, tissue, and gene therapy products, and medical devices.
Because each agency now recognizes the other’s GMP inspection results, a manufacturer no longer needs separate inspections to satisfy both regulators. The HSA estimates this eliminates about three duplicate inspections per manufacturer each year and can shorten time to market by up to six months. The agreement builds on the 2002 Japan-Singapore Economic Partnership Agreement and a 2010 information-exchange arrangement between the two regulators.
A Broader Reliance Strategy
The HSA also holds observer status in the Medical Device Single Audit Program (MDSAP), which allows a single audit to satisfy regulators in the United States, Canada, Japan, Brazil, and Australia. The HSA plans to apply for full MDSAP membership in the second half of 2026.
These initiatives reduce the number of independent reviews a device must pass to reach multiple markets. A company that secures HSA approval gains a faster path into Malaysia under the reliance program, a smoother submission process with MHRA under the UK corridor, and expanded common ground with NMPA and MHLW on manufacturing inspections and product categories.
Implications for Device Companies
Companies planning market entry into Asia have a practical reason to sequence their regulatory strategy around Singapore. An HSA approval now carries weight with regulators in Malaysia, the UK, China, and Japan in ways that reduce duplicate review work and compress timelines. Companies developing devices in cell and gene therapy, advanced diagnostics, or oncology should track these pathways closely, since HSA and its partner agencies have named these categories as priorities for pilot schemes and expedited review.
The reliance model also raises the importance of aligning quality systems and GMP documentation across markets from the start of development. Companies that build their compliance and clinical evidence strategy around this level of regulatory coordination are positioned to reach several Asian and European markets faster than the traditional country-by-country approach allows.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
