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 milestone signifies that Singapore – which falls under WHO’s Western Pacific Region – is managing a strong, quality assured and continually improving system for medical devices regulation.
Regulating medical devices ensures their quality and safety, protecting patients and ensuring effective care. Medical devices include thermometers, blood pressure monitors, diagnostic tests, surgical tools and other life‑saving equipment used every day in health care.
WHO led a team of international experts to assess Singapore's national regulatory system, represented by the Health Sciences Authority (HSA). The benchmarking held in February 2026 was in close collaboration with the WHO Regional Office for the Western Pacific and the WHO Representative Office for Malaysia, Brunei Darussalam and Singapore.
“It is a great honor for Singapore’s Health Sciences Authority to be recognized at the highest WHO Maturity Level (ML4) classification for medical device regulation,” said Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, Singapore. “Together with our ML4 status for medicines and as a Stringent Regulatory Authority for high-risk in-vitro diagnostics, this milestone reflects HSA’s sustained effort to build a robust and forward-looking regulatory system that safeguards patients while enabling timely access to innovative health products. HSA will continue to collaborate closely with WHO and partners to share experience and support regulatory capacity building across the Region, whilst at the same time work with regulators to establish HSA as a global reference point that they can confidently rely on for the evaluation of their products."
Dr Rabindra Abeyasinghe, WHO Representative to Malaysia, Brunei Darussalam and Singapore, shared: “I congratulate the Singapore Health Sciences Authority in achieving the highest maturity level – ML4 – status for medical devices regulation after being the first country in the Western Pacific Region to undergo this extended WHO global benchmarking. This landmark achievement in public health reflects Singapore’s sustained commitment to strong regulatory systems to support access to quality, effective health products and ensure patient safety. WHO looks forward to continuing our collaboration with the Government of Singapore for advancing regulatory innovation, strengthening systems, providing an example for other Member States to follow, and ensuring better health for all, both within Singapore and across the Region.”
A well-functioning, advanced and sustainable regulatory system is essential to public health and universal health coverage. Apart from supporting the timely access to quality assured and safe medical products and devices, strong regulatory systems protect patients and health systems from substandard and falsified products, and enable efficient procurement, regulatory reliance, and regional collaboration.
Singapore’s accomplishment builds on the country’s designation as a WHO-Listed Authority (WLA) in 2023. These achievements underscore the critical role of regulatory systems strengthening in advancing equitable access to quality medical products and devices in the Western Pacific Region and globally.
WHO’s benchmarking framework evaluates regulatory authorities against more than 260 indicators covering key functions such as regulatory systems, product registration and market authorization, laboratory testing, post-market surveillance, clinical trials oversight, regulatory inspections and licensing of establishments. The assessment determines the maturity and functionality of national regulatory systems and supports their continuous improvement.
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For more information, please contact:
WHO Regional Office for the Western Pacific: wprocom@who.int
WHO Representative Office for Malaysia, Brunei Darussalam and Singapore: chaudharyv@who.int