Singapore earns top WHO rating for medical device regulation

SINGAPORE—The World Health Organization has recognized Singapore’s Health Sciences Authority with its highest regulatory performance rating for medical devices.

Following a comprehensive assessment in February 2026, the HSA achieved maturity level 4 (ML4), making Singapore the first WHO Member State to reach this pinnacle classification in medical device oversight.

The designation confirms that Singapore’s regulatory system operates at an advanced level with mechanisms for continuous improvement.

The framework ensures medical devices meet rigorous standards for safety, quality and performance throughout their entire lifecycle, from initial market authorization and clinical evaluation through post-market surveillance.

A global medical technology hub

Singapore hosts approximately 200 medical device manufacturers producing a diverse range of products, from in vitro diagnostics to software-based medical devices.

This thriving ecosystem positions the city-state as a major global hub for medical technology innovation.

Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized that effective regulation remains essential to ensure health products reaching patients are safe, effective and of assured quality.

She noted that 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.

Setting a global standard

The recognition provides an important reference point for other countries working to strengthen their regulatory systems.

Globally, regulatory capacity remains uneven, with only 32 percent of regulatory authorities worldwide having the capacity to fully ensure that medicines, vaccines and other health products meet required standards.

The WHO benchmarking assessment involved international experts and WHO staff from headquarters and the Regional Office for the Western Pacific.

The team reviewed evidence submitted by HSA and conducted technical discussions with regulatory oversight teams.

Adjunct Professor Raymond Chua, Chief Executive Officer of the Health Sciences Authority, expressed great honour at receiving the ML4 classification.

With HSA’s ML4 status for medicines and its designation as a Stringent Regulatory Authority for high-risk in vitro diagnostics, this milestone shows continued work to build a strong, forward-looking regulatory system.

Building regional capacity

The HSA plans to collaborate closely with WHO and partners to share expertise and support regulatory capacity building across the region.

Singapore previously achieved the WHO’s highest maturity level for medicines and imported vaccines regulation in 2022 and received the WHO-Listed Authority designation for medicines in 2023.

The authority actively participates in international regulatory harmonization through the International Medical Device Regulators Forum, the Medical Device Single Audit Program and regional initiatives.

As Chair of the IMDRF Management Committee in 2026, HSA is positioned to advance global regulatory alignment for emerging technologies, including digital health solutions, artificial intelligence, and personalized medical devices.