Singapore revises healthcare AI guidelines, attains WHO top rating for medical device regulation

Singapore has revised its healthcare AI guidelines to enable more innovations to augment the healthcare workforce and new drugs to reach patients faster, Minister for Health Ong Ye Kung said on March 10.

The Health Sciences Authority (HSA) has also become the first national regulatory authority to attain the World Health Organization’s (WHO) highest level of medical device regulation, he said. The recognition enables HSA to serve as a global reference for other regulators worldwide.

Speaking at the opening of the International Medical Device Regulators Forum at NTUC Centre, Mr Ong said the Ministry of Health (MOH) and HSA co-developed and launched the revised healthcare AI framework that addresses developments in artificial intelligence, such as generative AI, to better support innovation, while ensuring safety and quality.

In his speech, Mr Ong said regulatory sandboxes will facilitate the evaluation of AI solutions in real-world healthcare settings, ensuring that AI tools are built using quality, real-life data.

He added that HSA has not received any registration application for AI-developed drugs, but it would welcome such applications in the near future.

AI is revolutionising the drug development process, as simulated laboratory data is being used to replace traditional early-phase clinical trials, which are costly and time-consuming.

HSA “will take a technology-neutral approach to regulation, applying the same rigour to AI-developed drugs as it does to conventional drugs”, Mr Ong said. 

This will ensure that as technology advances, Singapore can embrace innovation while taking care of the risks.

In his speech, Mr Ong said HSA can also help boost Singapore’s competitiveness in the biomedical industry by strengthening its position as a regional and global reference authority.

In 2022, HSA received the highest possible rating from WHO for its medicine regulatory system, which affirmed that the system was operating at a world-class, advanced level.

Some other countries have also reached this so-called Maturity Level 4 for medicines.

Mr Ong said jurisdictions such as Australia, Hong Kong, Malaysia, the Philippines, South Africa, Sri Lanka, Switzerland, Thailand and the United Kingdom reference HSA approvals in expediting their regulatory processes for medical devices or pharmaceutical products. 

Likewise, HSA also benchmarks its regulatory processes against those of other advanced jurisdictions such as the US, European Union, United Kingdom and Japan.

“Ultimately, health regulation comprises a network of international cooperation, in which Singapore will be one of the key nodes,” Mr Ong said.

Singapore is also a member of a consortium that approves new therapeutic products to ensure faster access to safe and effective pharmaceuticals. The other members are Australia, Canada, Switzerland and the UK.

“All these help establish Singapore as a gateway for market access to hundreds of millions of people in many other countries and regions. Singapore is no longer just a market of six million people,” Mr Ong said. 

Adjunct Professor Raymond Chua, HSA chief executive and deputy director-general of health (health regulation) at MOH, said the WHO achievement comes as HSA takes on an additional role that is economic in nature to help grow Singapore’s biomedical sector.

HSA will work alongside universities, academic medical centres, hospitals and A*STAR to strengthen the biomedical innovation pipeline, which could potentially result in, for instance, impactful clinical applications.

It will also continue to partner with other public sector agencies to enhance Singapore’s clinical trial capabilities and grow the number of trials, among other initiatives.

Prof Chua, in his speech at the opening ceremony of the forum, said: “The future of healthcare will not be shaped by innovation alone, but by the wisdom with which we govern it.”

Mr Ong said that to future-proof a rapidly evolving health and medical technology sector – driven by developments in AI, precision medicine and next-generation diagnostics – Singapore will consolidate various agency functions, including HSA’s, to better support the growth of the biomedical industry.

The country will explore opportunities to align companies’ product offerings with its priority disease areas, such as cardiovascular diseases, diabetes and metabolic disorders. This approach will enable joint development of tailored pathways that facilitate regulatory approval, health technology assessment, and clinical development and application at the same time, said Mr Ong.

“This will be a useful synergy within MOH. Although small, Singapore is a valuable commercial reference market – at least we believe that. When a product succeeds in Singapore, it sends a strong positive signal to global markets,” he said.

Historically, Singapore has been a dynamic trading post connecting the East and West, later evolving into a centre of global finance. As its economy matures, it is becoming a regional hub in manufacturing, maritime, aviation, infocommunications and professional services.

“In today’s world, Singapore offers not just connections in the trade of physical goods, services and investments,” said Mr Ong. “We also serve as an interface for varying standards and regulations around the world, where the common currency is trust, integrity and credibility.” 

HSA can play this role well and contribute to advancing global healthcare while keeping Singapore’s healthcare safe and effective, he added.

Source: The Straits Times © SPH Media Limited. Permission required for reproduction.

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