JAKARTA - On March 10, 2026, the World Health Organization (WHO) announced that the Singapore Health Sciences Authority (HSA) had achieved the highest performance classification for medical devices globally.
Quoted from the WHO official website, on Wednesday, March 11, 2026, through a comprehensive assessment of HSA reached maturity level 4 (ML4), the highest classification in the WHO system for national regulatory authorities that oversee medical products.
Thus, Singapore became the first WHO member country to reach this level of regulation of medical devices. This coronation also shows that Singapore's regulatory system operates at an advanced level of performance.
Starting from mechanisms for continuous improvement, and consistently ensuring the safety, quality, and performance of medical devices throughout the life cycle, from market authorities and clinical evaluation to post-market surveillance.
"Singapore's achievement reflects an extraordinary commitment to regulatory excellence and demonstrates how sustained investment in regulatory capacity can protect populations, support innovation, and strengthen confidence in medical technologies," said Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access, and Data.
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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.
With the status as the highest classification in the WHO medical device regulation, Singapore is committed to continuing to build a strong and visionary regulatory system to protect patients in the future.
"This milestone reflects HSA's ongoing efforts to build a strong and forward-looking regulatory system that protects patients while enabling timely access to innovative health products," said Assistant Producer Dr. Raymond Chua, Chief Executive Officer, Singapore Health Sciences Authority.
In addition to continuing to build medical regulatory capacity across the region, Singapore is also committed to continuing to collaborate with the WHO and as a global reference.
"HSA will continue to collaborate closely with WHO and partners to share experiences and support regulatory capacity building across the region, while at the same time working with regulators to establish HSA as a global reference point," concluded Raymond Chua.
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