The World Health Organization (WHO) announced today that Singapore's Health Sciences Authority (HSA) has achieved the highest level of regulatory performance for medical devices under WHO's global benchmarking framework.
Following a comprehensive assessment using WHO's Global Benchmarking Tool Plus for medical devices (GBT+MD), HSA reached maturity level 4 (ML4), the highest classification in WHO's system for national regulatory authorities overseeing medical products. Singapore is the first WHO Member State to attain this level for medical device regulation.
The designation confirms that Singapore's regulatory system operates at an advanced level of performance with mechanisms for continuous improvement, and consistently ensures the safety, quality and performance of medical devices throughout their life cycle, from market authorization and clinical evaluation to post-market surveillance.
Singapore is a major global hub for medical technology innovation, with around 200 manufacturers producing a wide range of devices, from in vitro diagnostics to software as a medical device.
"Effective regulation is essential to ensure that health products, including medical devices, reaching patients are safe, effective and of assured quality," said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. "Singapore's achievement reflects an exceptional commitment to regulatory excellence and demonstrates how sustained investment in regulatory capacity can protect populations, support innovation and strengthen trust in medical technologies. It also provides an important reference point for other countries working to strengthen their own regulatory systems and ensure access to safe and quality-assured health products."
Globally, regulatory capacity remains uneven. 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, quality and effectiveness. WHO benchmarking therefore helps identify areas for improvement towards establishment of stable, well-functioning and integrated regulatory systems in WHO Member States.
The benchmarking assessment was conducted in February 2026 by a team of international experts together with WHO staff from headquarters and the WHO Regional Office for the Western Pacific. The process included a review of evidence submitted by HSA and technical discussions with teams responsible for regulatory oversight.
"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".
Singapore previously achieved WHO's highest maturity level for medicines and imported vaccines regulation in 2022. Regulatory authorities reaching ML4 may qualify as a WHO Listed Authority (WLA) after additional performance assessments – a designation recognizing health regulators that can serve as reference authorities for other countries when making decisions about approving medical products. HSA was designated as a WLA for medicines in 2023 and listed in 2024 for an expanded scope covering all regulatory functions for the medicines product stream.
HSA plays an active role in international regulatory harmonization, including participation in the International Medical Device Regulators Forum (IMDRF), the Medical Device Single Audit Program (MDSAP) and regional initiatives. As Chair of the IMDRF Management Committee in 2026, the regulatory authority is positioned to help advance global regulatory alignment for emerging technologies, such as digital health solutions, artificial intelligence and personalized medical devices.
