Singapore has achieved WHO's highest classification for medical device regulation, ML4, demonstrating its commitment to regulatory excellence and providing an important reference point for other countries working to strengthen their own regulatory systems. The designation indicates Singapore's regulatory system operates at an advanced level of performance and ensures the safety, quality and performance of medical devices throughout their life cycle. Only about 32% of regulatory authorities worldwide have the capacity to fully ensure that medicines, vaccines and other health products meet required standards of safety and quality and effectiveness. The benchmarking assessment was conducted in February 2026 by international experts and WHO staff from headquarters and the WHO Regional Office for the Western Pacific. Singapore previously achieved WHO’s highest maturity level for medicines and imported vaccines regulation in 2022.