Singapore’s Health Sciences Authority (HSA) has strengthened international regulatory collaboration through two Memoranda of Understanding (MOUs) signed during the 16th International Conference on Medical Regulation 2025. On September 4, the HSA signed an MOU with Australia’s Therapeutic Goods Administration (TGA) to facilitate information exchange, regulatory approval, and staff development. On September 5, the HSA signed a second MOU with Ireland’s Health Products Regulatory Authority (HPRA) to help improve communication, regulatory policies, and post-market vigilance. The HSA anticipates that the collaborations will support the HSA’s goals of improving approval efficiency and demonstrate Singapore’s commitment to the safety of health products globally.
In late September, the Japanese reimbursement agency Chuikyo discussed more specific criteria to “challenge reimbursement applications.” This is one of the topics for the 2026 medical device reimbursement list and higher prices. Basically, reimbursement amounts can be re-evaluated if there were certain benefits that were not available or not taken into consideration when the initial medical device reimbursement was determined. Given this new direction, medical device companies can reapply for a higher reimbursement if they can show, via randomized controlled trials (with competing products), new findings that exhibit relevant improvements. If the follow-up studies do not have a real competitor, they will not be considered.
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.