Singapore has made history by becoming the first World Health Organisation (WHO) Member State to achieve the highest maturity level (ML4) in the regulation of medical devices. This significant milestone, announced on 11 March 2026, highlights Singapore’s robust and continually improving regulatory system, ensuring the quality and safety of medical devices such as thermometers, blood pressure monitors, and surgical tools.
The Health Sciences Authority (HSA) of Singapore was assessed by a team of international experts led by WHO, in collaboration with the WHO Regional Office for the Western Pacific and the WHO Representative Office for Malaysia, Brunei Darussalam, and Singapore. This evaluation took place in February 2026.
Adjunct Professor Raymond Chua, CEO of HSA, expressed pride in the achievement, stating, “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 whilst enabling timely access to innovative health products.”
Dr Rabindra Abeyasinghe, WHO Representative to Malaysia, Brunei Darussalam, and Singapore, praised the achievement, noting it as a landmark in public health that sets a precedent for other nations. He emphasised the importance of strong regulatory systems in ensuring patient safety and access to effective health products.
Singapore’s achievement builds on its designation as a WHO-Listed Authority in 2023, underscoring the critical role of regulatory systems in advancing equitable access to quality medical products globally. The WHO benchmarking framework evaluates regulatory authorities on over 260 indicators, ensuring continuous improvement in national regulatory systems.
