Singapore becomes first country to achieve WHO’s highest rating for medical device regulation

Singapore has set a global benchmark in health regulation, becoming the first country to achieve the highest classification under the World Health Organization framework for medical device oversight.

The milestone was announced following a rigorous assessment of the country’s regulatory system by WHO using its Global Benchmarking Tool Plus for medical devices. The Health Sciences Authority reached Maturity Level 4, the top tier in WHO’s classification, signalling an advanced and well functioning regulatory system with strong mechanisms for continuous improvement.

This designation reflects Singapore’s ability to ensure the safety, quality and performance of medical devices across their entire lifecycle, from market authorisation and clinical evaluation to post market surveillance. It also underscores the country’s growing role as a global hub for medical technology innovation, with around 200 manufacturers producing a wide spectrum of devices including diagnostics and software based tools.

Speaking on the achievement, Yukiko Nakatani highlighted the broader significance of strong regulatory systems in public health. She noted that effective regulation is essential to ensure that health products reaching patients are safe and of assured quality, adding that Singapore’s success demonstrates how sustained investment in regulatory capacity can both protect populations and foster innovation.

The recognition comes against a backdrop of uneven regulatory capacity worldwide. According to WHO, only around 32 per cent of national regulatory authorities globally have the capability to fully ensure that medicines, vaccines and other health products meet required standards. The benchmarking framework is therefore designed not only to assess performance but also to guide countries in strengthening their systems.

The evaluation of Singapore’s regulatory framework was carried out in February 2026 by a team of international experts alongside WHO officials. The process involved a detailed review of submitted evidence as well as technical consultations with teams responsible for regulatory oversight.

For Singapore, the latest recognition builds on earlier achievements. The country had already attained the highest WHO maturity level for medicines and imported vaccines regulation in 2022. It was subsequently designated as a WHO Listed Authority for medicines in 2023, with an expanded scope granted in 2024, positioning it as a trusted reference point for other regulators worldwide.

Raymond Chua described the new classification as a significant milestone, reflecting years of effort to build a robust and forward looking regulatory system. He emphasised that the authority would continue to collaborate with WHO and international partners to support regulatory capacity building across the region while strengthening its role as a global reference authority.

Singapore’s regulatory agency is also deeply engaged in international harmonisation efforts. Through its participation in platforms such as the International Medical Device Regulators Forum and the Medical Device Single Audit Program, it is contributing to the alignment of standards for emerging technologies including digital health, artificial intelligence and personalised medical devices. As chair of the IMDRF Management Committee in 2026, the country is expected to play a central role in shaping future regulatory approaches.

The WHO benchmarking framework itself evaluates regulatory authorities across more than 260 indicators, covering areas such as product registration, laboratory testing, clinical trials oversight and post market surveillance. Achieving the highest maturity level signals not only compliance with global standards but also the presence of a stable, integrated and continuously improving regulatory system.

For global health systems grappling with rapid technological change, Singapore’s achievement offers both a model and a challenge, highlighting the importance of strong regulatory foundations in ensuring safe access to increasingly complex medical technologies.