Singapore Secures Leading WHO Medical Device Regulation Status

Key Takeaways

Singapore’s Health Sciences Authority (HSA) achieved the highest regulatory performance level (ML4) for medical devices as per WHO standards.
This recognition marks Singapore as the first WHO Member State to reach ML4, demonstrating a strong commitment to regulatory excellence.
HSA’s successful regulatory framework supports innovation and ensures the safety and quality of medical devices throughout their lifecycle.

Singapore’s Regulatory Achievement Recognized by WHO

The World Health Organization (WHO) has announced that Singapore’s Health Sciences Authority (HSA) has reached the highest regulatory maturity level (ML4) for medical devices, as part of its global benchmarking framework. This achievement, assessed using the WHO’s Global Benchmarking Tool Plus for medical devices, positions Singapore as the first WHO Member State to attain this prestigious level in medical device regulation.

Achieving ML4 confirms that Singapore maintains a robust regulatory system focused on continuous improvement, ensuring the safety, efficacy, and quality of medical devices from their market authorization to post-market surveillance. As a key global hub for medical technology, Singapore is home to approximately 200 manufacturers that produce a diverse range of innovative medical devices, including in vitro diagnostics and software products.

Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized the significance of effective regulation: “It is essential to ensure that health products, including medical devices, reaching patients are safe, effective, and of assured quality.” Singapore’s accomplishment highlights its dedication to regulatory excellence and serves as a model for other nations aiming to enhance their regulatory systems and improve access to quality health products.

Despite this progress, global regulatory capacity remains inconsistent, with only about 32% of regulatory authorities worldwide equipped to ensure the safety and effectiveness of health products. The WHO benchmarking process plays a vital role in identifying areas for improvement, aiming to establish stable and efficient regulatory systems among its member countries.

The assessment for HSA was conducted in February 2026 by an international team of experts alongside WHO staff. This involved a thorough review of evidence submitted by HSA and dialogues focused on regulatory oversight. Dr. Raymond Chua, CEO of HSA, described the achievement as a “great honor,” noting that it reflects the authority’s commitment to building a resilient regulatory system.

HSA previously achieved WHO’s ML4 for medicines and vaccine regulation in 2022 and was designated a WHO Listed Authority (WLA) for medicines in 2023. This status may also extend to medical devices following further evaluations. HSA actively participates in global regulatory harmonization initiatives, including the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP).

As the chair of IMDRF in 2026, HSA is poised to spearhead global alignment in regulatory practices, particularly in emerging technologies such as digital health solutions, artificial intelligence, and personalized medical devices.

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