Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have cooperated on harmonizing regulatory requirements and alignment with international frameworks. On July 18, 2025, the regulators signed a “Confidentiality Arrangement” and stated they are committed to furthering cooperation on areas including Good Manufacturing Practice (GMP) inspections and new technology integration in regulatory processes. In addition, the arrangement entails increased collaboration in the Medical Device Single Audit Program (MDSAP). The agencies reiterated that their common objective is to keep strengthening regulatory partnerships as major medical product regulators in Asia.
In addition, Singapore’s Health Sciences Authority (HSA) and Hong Kong’s Department of Health have signed a Memorandum of Understanding (MoU) aimed at enhancing cooperation in the regulation of pharmaceuticals, medical devices, traditional medicines, and tobacco/vaping products. The MoU will allow the exchange of technical information, collaboration in enforcement approaches, joint training programs, staff exchange, and scientific project collaborations. Both the HSA and the Hong Kong Department of Health are looking to improve public health protections and regional regulatory alignment.
At the same time, Singapore and Malaysia have launched the Medical Device Regulatory Reliance Program, which is a six-month pilot program running between September 1, 2025, and February 28, 2026. The HSA and Malaysia’s Medical Device Authority (MDA) will provide a streamlined process for the registration of Class B, C, and D medical devices. The two authorities will rely on each other’s regulatory assessments and approvals to take advantage of regulatory reliance, to accelerate approvals, reduce duplicative reviews, and reduce time-to-market.
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.