The World Health Organization (WHO)\u00a0announced today\u00a0that\u00a0Singapore\u2019s\u00a0Health Sciences Authority (HSA) has achieved\u00a0the highest level of regulatory performance for medical devices under WHO\u2019s global benchmarking framework.\u00a0\u00a0<\/p>\n
Following a comprehensive\u00a0assessment\u00a0using WHO\u2019s Global Benchmarking Tool Plus for\u00a0medical devices\u00a0(GBT+MD),\u00a0HSA\u00a0reached maturity level 4\u00a0(ML4),\u00a0the highest\u00a0classification\u00a0in WHO\u2019s\u00a0system for national regulatory authorities overseeing\u00a0medical\u00a0products.\u00a0Singapore is the first WHO Member State to\u00a0attain\u00a0this level for medical device regulation.\u00a0<\/p>\n
The\u00a0designation confirms that\u00a0Singapore\u2019s regulatory system\u00a0operates\u00a0at an advanced level\u00a0of performance with\u00a0mechanisms for\u00a0continuous improvement,\u00a0and\u00a0consistently ensures the safety,\u00a0quality\u00a0and performance of medical devices throughout their life cycle, from market authorization and clinical evaluation to post-market surveillance.\u00a0<\/p>\n
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.\u00a0\u00a0<\/p>\n
\u201cEffective regulation is essential to ensure that\u00a0health products, including medical devices,\u00a0reaching patients are safe, effective and of assured quality,\u201d\u00a0said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems,\u00a0Access\u00a0and Data.\u00a0\u201cSingapore\u2019s achievement\u00a0reflects\u00a0an exceptional commitment to regulatory excellence and\u00a0demonstrates\u00a0how sustained investment in regulatory capacity can protect\u00a0populations, support\u00a0innovation\u00a0and strengthen trust in\u00a0medical\u00a0technologies. It also provides an important reference point for other countries working to strengthen their own regulatory systems\u00a0and ensure access to safe and quality-assured health products.\u201d\u00a0<\/p>\n
Globally, regulatory capacity\u00a0remains\u00a0uneven.\u00a0Only 32% of regulatory authorities\u00a0worldwide\u00a0have the capacity to\u00a0fully\u00a0ensure\u00a0that\u00a0medicines,\u00a0vaccines\u00a0and other health products\u00a0meet\u00a0required standards\u00a0of safety,\u00a0quality\u00a0and effectiveness. WHO\u00a0benchmarking\u00a0therefore helps\u00a0identify\u00a0areas for improvement towards establishment of stable, well-functioning and integrated regulatory systems in WHO\u00a0Member\u00a0States.\u00a0\u202f\u00a0<\/p>\n
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\u00a0submitted\u00a0by HSA and technical discussions with teams responsible for regulatory oversight.\u00a0<\/p>\n
\u201cIt is a great honor for Singapore\u2019s Health Sciences Authority to be recognized at the highest WHO Maturity Level (ML4) classification for medical device regulation,\u201d\u00a0said Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, Singapore. \u201cTogether with our ML4 status for medicines and as a Stringent Regulatory Authority for high-risk in-vitro diagnostics, this milestone reflects HSA\u2019s sustained effort to build a robust and forward-looking regulatory system that safeguards patients while enabling timely access to innovative health products.\u00a0HSA 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”.<\/p>\n
Singapore previously achieved WHO\u2019s highest maturity level for medicines\u00a0and imported vaccines\u00a0regulation in 2022.\u00a0Regulatory authorities\u00a0reaching\u00a0ML4\u00a0may\u00a0qualify\u00a0as\u00a0a\u00a0WHO Listed Authority\u00a0(WLA)\u00a0after\u00a0additional\u00a0performance assessments\u00a0\u2013\u00a0a\u00a0designation recognizing\u00a0health\u00a0regulators that can serve as reference\u00a0authorities\u00a0for other countries when making decisions about approving medical products.\u00a0HSA\u00a0was\u00a0designated\u00a0as a WLA\u00a0for medicines\u00a0in 2023 and listed\u00a0in 2024\u00a0for an expanded scope\u00a0covering\u00a0all regulatory functions for the\u00a0medicines\u00a0product stream.\u00a0<\/p>\n
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)\u00a0and\u00a0regional initiatives. As Chair of the IMDRF Management Committee in\u00a02026,\u00a0the regulatory authority\u00a0is positioned to\u00a0help advance\u00a0global\u00a0regulatory\u00a0alignment for emerging technologies,\u00a0such as digital health solutions, artificial\u00a0intelligence\u00a0and personalized medical devices.\u00a0<\/p>\n
About\u00a0WHO Global Benchmarking Tool\u00a0Plus for\u00a0medical\u00a0devices:\u00a0GBT+MD is an extension of\u00a0WHO\u2019s Global Benchmarking Tool (GBT), designed to assess and strengthen national regulatory systems for medical devices. While based on regulatory principles common to other medical products such as medicines and vaccines, the GBT+MD addresses the specific challenges associated with regulating medical technologies.\u00a0<\/p>\n
WHO\u2019s 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\u00a0inspections\u00a0and licensing of establishments. The assessment\u00a0determines\u00a0the maturity and functionality of national regulatory systems and supports their continuous improvement.\u00a0<\/p>\n
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