Speeches
SPEECH BY MR ONG YE KUNG, MINISTER FOR HEALTH AND COORDINATING MINISTER FOR SOCIAL POLICIES, AT THE 29TH SESSION OF THE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM
10 March 2026
IMDRF Management Committee and Members
Distinguished guests
Ladies and gentlemen
1. I am very happy to join you today at this 29th Session of the International Medical Device Regulators Forum. A forum like that is always a very good platform to share best practices and to learn from each other. So today, I am going to devote almost all of my speech to talk about the Health Sciences Authority and the journey HSA has taken so far, and I hope these are useful experiences to share and reference.
2. The Health Sciences Authority (HSA) of Singapore is a quiet and understated agency. It can always be counted on to rise to the occasion when needed.
3. For example, during the COVID-19 pandemic, HSA stood on the critical path to recovery, as it had to authorise life-saving vaccines under the Pandemic Special Access Route without the benefit of full data. So it had to exercise judgement and take some risk. But because of HSA’s work, we were able to roll out these life-saving vaccines, and Singapore emerged from the COVID-19 pandemic with one of the lowest fatality rates in the world.
4. Then we have this scourge called e-vaporisers, and after a while people added etomidate into the e-vaporisers and it became a problem. Then, e-vaporisers were regulated by HSA in Singapore, and now e-vaporisers with etomidate naturally came under the purview of HSA. And so it was HSA which, in a very short period of time, built up its enforcement capabilities to tackle the problem head-on. Before etomidate vapes, HSA did not even have such enforcement functions.
5. I therefore salute HSA for its many critical roles – clinical, regulatory and enforcement.
6. And today I will explain how HSA can take on another important role – which is economic in nature. That is to help develop and grow Singapore’s biomedical sector. There is a great opportunity to do so because medical technology is advancing rapidly, and Artificial Intelligence (AI), precision medicine, and next-generation diagnostics promise to revolutionise healthcare. And as Adj Prof (Dr) Raymond Chua mentioned, it is not just technology that is driving this revolution, but also the way we are regulated.
Healthcare’s Role in Economic Development
7. The bulk of healthcare in Singapore is delivered through public healthcare institutions under the Ministry of Health (MOH). Our system is quite well regarded internationally, with three of our public hospitals ranked amongst the world’s top 100 hospitals. The Global Health Index also ranks Singapore as one of the healthiest societies in the world.
8. Singapore could have promoted medical tourism. In fact, we get questioned all the time, “Why don’t we promote medical tourism?” And we could have generated a lot of income and created jobs through our public healthcare system. But we chose not to do so. Instead, we focused our mission on taking care of Singaporeans, by providing affordable, accessible, and quality healthcare.
9. We have concluded that in clinical care, it is difficult to juggle the dual objectives of contributing to economic growth and taking care of our people at the same time. Something has to give. Resources will be split, management attention will be diffused, and cherry-picking of patients will occur. Taking care of the general population under such circumstances will tend to lose out, and we do not want that to happen.
10. That said, outside of clinical care, the larger healthcare ecosystem does play a role in promoting economic growth and job creation, in the following ways:
11. First, in research and development. Singapore’s total research and development spending – which includes both public and private sector spending – is about 2% of GDP every year. A large part of it is driven by public expenditure, through the Research, Innovation and Enterprise (RIE) Plan. The latest plan, RIE2030, allocated S$37 billion (approximately US$29 billion) for the next five years.
12. The RIE focuses its investment in four key domains, one of which is Human Health and Potential. Through sustained investment, Singapore has built strong biomedical research, clinical translation and biomanufacturing capabilities.
13. Our universities, academic medical centres, hospitals, along with the Agency for Science, Technology and Research (A*STAR), they are key entities and partners in our end-to-end biomedical innovation pipeline. They translate fundamental science into clinical applications, industry partnerships, and globally investible ventures.
14. Second area is in drug development, and Singapore is an active player in clinical trials. Due to our small population, we cannot match the large clinical trial centres like China or India. However, the patient mix in Singapore is very diverse, and we have a reputable and well-trusted regulatory and clinical ecosystem. This enables us to be part of multi-centre clinical trial networks
15. About 100 industry-sponsored clinical trials are started in Singapore every year, which is already significant given the size of our population. Agencies such as HSA and the Consortium for Clinical Research and Innovation Singapore (CRIS) are working together to enhance our clinical trial capabilities and grow that number.
16. Third area, we are a production base for many top global biomedical companies. Our biopharmaceutical manufacturing output has doubled over the last two decades to S$13.9 billion in 2023. MedTech manufacturing output grew about tenfold over the same period to about S$18.9 billion in 2023.
17. We made production attractive in Singapore through a highly skilled and disciplined workforce, stable environment, logistical capabilities, access to multiple markets including through our free-trade agreements, robust accreditation infrastructure, as well as an excellent intellectual property protection regime.
18. Our domestic demand is modest. I always say that within one week, we produce the output needed for Singapore for the whole year. So the great majority of our products are produced to meet overseas demand. And this was demonstrated during the COVID-19 pandemic, where despite a scramble for medical resources, all export contracts in Singapore were honoured.
19. In addition to these three areas is another emerging opportunity where HSA can help strengthen Singapore’s competitiveness in the biomedical industry, and that is in health regulation. I am glad to see that HSA is gearing itself to seize this opportunity. It is well-placed to do so, due to many years of good work that has built up its competencies and reputation. More importantly, I can see that HSA is enthusiastic and determined to succeed in this area. It will bring economic benefits to Singapore, and at the same time, further strengthen HSA’s contribution to healthcare for our population and also to the global regulatory framework.
20. HSA’s latest endeavour comprises the following three key thrusts.
A Strong International Reference Authority
21. First, HSA will strengthen its position as a regional and global reference authority. As a regulatory authority for medicines, in 2022, HSA was the first international regulator to achieve the World Health Organization (WHO) Maturity Level 4 (ML4) status and was among the first three regulators recognised as a WHO Listed Authority.
22. For high-risk in vitro diagnostics, since 2023, HSA has been recognised as a WHO Stringent Regulatory Authority (SRA).
23. This year, HSA has also achieved the highest WHO maturity level of ML4 for medical devices – the first national regulatory authority worldwide to reach this milestone. Congratulations to HSA. We are grateful for the WHO’s support and expertise throughout this journey. It has been a very valuable experience, and I encourage other Member States to undertake this benchmarking exercise. We look forward to continuing our close collaboration with WHO to strengthen global regulatory harmonisation.
24. The credentials recognise HSA’s advanced level of regulatory performance. They establish HSA as a global reference point that other regulators can confidently rely upon.
25. For example, 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.
26. Likewise, HSA also references its health products regulatory processes with other advanced jurisdictions in the world, such as the United States, European Union, the United Kingdom and Japan. Ultimately, health regulation comprises a network of international cooperation, in which Singapore will be one of the key nodes.
27. Singapore is also a member of the Access Consortium alongside Australia, Canada, Switzerland, and the United Kingdom. Through the Consortium, we align our regulatory practices, share the workload of approving new therapeutic products and better manage resource constraints. This way, we reduce unnecessary duplication, ensure faster approval processes for safe and effective therapeutic products, and benefit patients across all member countries of the Access Consortium.
28. 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.
Holistic Value Proposition
29. Second value proposition of the HSA is that the Singapore Government will pull various agency functions together, including the HSA’s, to put forward a holistic value proposition to the biomedical sector.
30. What do I mean by that? For example, for international biomedical companies establishing a presence in Singapore, we bring together A*STAR to anchor translational research and industry-relevant innovation, the Economic Development Board (EDB) to the table to facilitate manufacturing investment, and HSA for a rigorous and expedient registration process.
31. For homegrown companies, Enterprise Singapore (ESG) helps to facilitate access to regional and global markets, and HSA provides early guidance and capability development to avoid regulatory pitfalls.
32. Within MOH, we can do more as well, and there are opportunities to offer a more holistic approach to partnering biomedical companies too. Biomedical companies typically have three interfaces in MOH – HSA for product registration, the Agency for Care Effectiveness (ACE) for health technology assessment, and public health clusters for clinical development and application.
33. We will explore opportunities to align companies’ product offerings with Singapore's priority disease areas such as cardiovascular diseases, diabetes, and metabolic disorders. By doing so, we can jointly develop tailored pathways that facilitate regulatory approval, health technology assessment and clinical development and application at the same time.
34. 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.
Evolving our Regulatory Framework
35. Third, HSA is evolving its regulatory framework as technology advances. Artificial intelligence, genomics and precision medicine hold great promise to transform healthcare. The march of science and innovation is relentless and fast-paced, but it can also give rise to unintended risks and raise ethical questions.
36. The role of healthcare regulation is neither to voluntarily side-step the advancement nor to counter it with maximum resistance. Regulation instead mediates between what is scientifically and clinically possible and what is socially and publicly acceptable. It finds a consensual path between commercial aspirations and the health and wellbeing of the population, as well as the financial sustainability of healthcare systems.
37. This is what HSA will continue to strive to contribute towards. It means constantly evolving its regulatory regime, so that we can embrace innovation, while taking care of the risks and the downsides.
38. One key initiative that we are launching today, mentioned by Adj Prof (Dr) Raymond Chua, is the updated AI in Healthcare Guidelines, or AIHGle 2.0. It updates the original 2021 framework to address developments in AI, such as Gen AI, to better support innovation, while ensuring safety and quality, preserving ethics and values of the healthcare profession.
39. The updated guidelines will enable our healthcare institutions to build and implement clinically safe and effective AI solutions. Regulatory sandboxes will be set up, and this will help the evaluation of these AI solutions in real-world healthcare settings.
40. An example featured in AIHGle 2.0 is the AI-Software as a Medical Device Exemption Sandbox. It allowed public healthcare institutions to deploy low-to moderately low-risk AI-driven medical devices for their in-house use without the typical licensing and registration requirements.
41. This is a practical and useful arrangement, because AI tools have to be built using quality, real-life data, which are generated in situ. Hence, they are inherently not laboratory products.
42. We invite private sector partners to collaborate with our public health institutions to improve and transform healthcare.
43. AI is also used to develop new drugs. This revolutionises the drug development process, by replacing costly and time-consuming early phase clinical trials with laboratory-generated simulated data. HSA will accept such applications for registration. It will take a technology-neutral approach to regulation, applying the same rigour to AI-developed drugs as it does to conventional drugs.
44. This means HSA has to examine the AI model, validate the data pipelines, ensure transparency of data sources, and objectively evaluate the quality, reliability and reproducibility of the drug. We have thus far not received an application for registration of an AI-developed drug, but would welcome one in the near future.
Bridge and Connector
45. Let me conclude. Historically, Singapore has been a dynamic trading post, connecting the East and the West. Later, leveraging our time zone, we became a centre of global finance. As our economy matures, we are becoming a regional hub in manufacturing, maritime, aviation, infocomms, and professional services. Singapore thrived because of globalisation, and globalisation, despite everything that has happened in recent years, is far from dead.
46. In today's world, Singapore offers not just connections in the trade of physical goods, services and investments. We also serve as an interface for varying standards and regulations around the world, where the common currency is trust, integrity and credibility. I believe HSA can play this role well and contribute to advancing global healthcare while keeping Singapore’s healthcare safe and effective.
47. On that note, I wish you a productive and successful forum ahead. Thank you.