Singapore First to Achieve WHO’s Top Medical Device Regulation Rating

The designation follows an extensive assessment using the WHO Global Benchmarking Tool Plus for Medical Devices (GBT+MD).

Singapore has become the first country in the world to achieve the highest regulatory maturity level for medical device oversight under the World Health Organization’s (WHO) global benchmarking framework, marking a major milestone in global health regulation.

The WHO announced that Singapore’s Health Sciences Authority (HSA) has attained Maturity Level 4 (ML4)—the highest classification in WHO’s system for national regulatory authorities overseeing medical products—after a comprehensive evaluation of its regulatory framework.

Global Benchmark for Medical Device Regulation

The designation follows an extensive assessment using the WHO Global Benchmarking Tool Plus for Medical Devices (GBT+MD). The evaluation examined the full life cycle of medical device regulation in Singapore, including:

• Market authorization and product approval

• Clinical evaluation processes

• Quality assurance standards

• Post-market surveillance and monitoring

Achieving ML4 status confirms that Singapore operates an advanced, well-functioning regulatory system with strong mechanisms for continuous improvement, ensuring that medical devices entering the market remain safe, effective, and of high quality.

WHO Praises Singapore’s Regulatory Excellence

WHO officials described Singapore’s achievement as a model for countries seeking to strengthen health product regulation.

“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.”

She added that the milestone provides an important reference point for other countries working to improve their regulatory systems.

Singapore’s Growing Role in Global MedTech Innovation

Singapore is widely recognized as a major global hub for medical technology innovation, hosting around 200 manufacturers producing a diverse range of devices.

These include:

• In vitro diagnostic technologies

• Advanced imaging systems

• Digital health solutions

• Software as a medical device

• Emerging artificial intelligence-enabled healthcare technologies

A robust regulatory framework has been key to attracting international medical technology companies while ensuring patient safety.

HSA Highlights Strong Regulatory System

Adjunct Professor Dr Raymond Chua, Chief Executive Officer of Singapore’s Health Sciences Authority, described the recognition as a major milestone for the country’s healthcare system.

“It is a great honor for Singapore’s Health Sciences Authority to be recognized at the highest WHO Maturity Level classification for medical device regulation,” Chua said.

He noted that the designation complements Singapore’s ML4 status for medicines regulation and its recognition 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,” he said.

Regulatory Capacity Still Uneven Globally

WHO data shows that only about 32% of regulatory authorities worldwide currently have the capacity to fully ensure that medicines, vaccines, and medical devices meet international safety and quality standards.

The WHO benchmarking system was developed to help countries evaluate and strengthen their regulatory systems through standardized performance assessments.

The benchmarking review of Singapore was conducted in February 2026 by international regulatory experts working alongside WHO staff from headquarters and the Western Pacific Regional Office.

Toward Global Reference Authority Status

Singapore has steadily strengthened its regulatory capabilities in recent years.

Key milestones include:

• 2022: Achieved WHO ML4 status for regulation of medicines and imported vaccines

• 2023: Designated as a WHO Listed Authority (WLA) for medicines

• 2024: Expanded WLA recognition to cover the full medicines regulatory stream

Regulatory agencies reaching ML4 may qualify as WHO Listed Authorities, enabling other countries to rely on their evaluations when approving medical products.

Leadership in Global Regulatory Cooperation

Singapore’s Health Sciences Authority also plays an active role in international regulatory harmonization efforts.

The agency participates in major global initiatives including:

• International Medical Device Regulators Forum (IMDRF)

• Medical Device Single Audit Program (MDSAP)

• Regional regulatory cooperation programmes

In 2026, Singapore will serve as Chair of the IMDRF Management Committee, positioning it to guide international collaboration on emerging technologies such as artificial intelligence, digital health platforms, and personalized medical devices.

Health experts say Singapore’s new designation strengthens its status as a global reference authority for medical device regulation, helping shape international standards while supporting safe access to innovative healthcare technologies.