Singapore achieves highest WHO Maturity Level for medical devices regulation
Published on March 11, 2026.
Singapore has become the first WHO Member State globally to achieve the highest maturity level (ML4) in WHO's classification of regulatory authorities for medical devices. This achievement indicates Singapore is managing a strong, quality assured and continually improving system for medical device regulation. The WHO led a team of international experts to assess Singapore's national regulatory system, represented by the Health Sciences Authority (HSA). The benchmarking took place in February 2026 and was conducted in close collaboration with the WHO Regional Office for the Western Pacific and the WHO Representative Office for Malaysia, Brunei Darussalam and Singapore. This milestone reflects Singapore's commitment to strong regulatory systems to support access to quality, effective health products and ensure patient safety.
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