Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innovation as a Catalyst for Global Medtech Growth" for Singapore Medical Device Venture Showcase

Introduction

Distinguished Guest of Honour, Dr Tan See Leng, Minister for Manpower and Minister-in-charge of Energy and Science & Technology in the Ministry of Trade and Industry.

Esteemed leaders from A*STAR, Economic Development Board, Enterprise Singapore, MedTech Catapult, ClavystBio, and our many ecosystem partners,

Ladies and gentlemen, a very good evening to all of you. First of all, thanks to MedTech Catapult for inviting me here to this event.

1 What you just watched is a glimpse of where we are heading soon. A digital twin of a clinician, conducting consultation in ways that were unimaginable just a few years ago. That is precisely the kind of bold, patient-centred innovation that excites us at HSA, like that of the capsule endoscopy you see here replacing that of invasive endoscopies, and that we are here to support.

2 It is a privilege to be here with you at the Singapore Medical Device Venture Showcase. Many of you are inventors and investors of some of the most innovative medical solutions there are today. Everyone, brimming with hope to bring these solutions to multiple markets and the patients there. And you want to do so quickly.

3 I know many of you believe that Singapore is the place to do so. And I want to share with you how HSA can be your partner, so that your MedTech offerings can reach markets and patients in a safest and speediest way.

Singapore’s Whole-of-Government Launchpad

4 Singapore has a solid foundation for medical technology development and innovation, as part of its efforts to grow the healthcare sector. The Government has been committing over the years to do so. For instance, it committed S$37 billion in funding for the latest Research, Innovation and Enterprise 2030 plan, which includes the healthcare sector.

Three Pillars of HSA’s Strategy to Support the MedTech Ecosystem

5 How can HSA help you springboard into markets? Let me share three key ways. Over the past years, we have organised our efforts around three interconnected pillars of Global Market Access, Holistic Value Proposition to Product Development, and Adaptive Regulation. These pillars have been developed to address what global venture capitalists and ambitious MedTech companies tell us they need most: predictability, speed to markets, clarity on value, and future-readiness.

Pillar One: Global Market Access

6 First, HSA is an international reference authority that enables global market access. Three months ago, in March 2026, the World Health Organization made history with Singapore. Following a rigorous assessment using the WHO Global Benchmarking Tool Plus for medical devices, HSA achieved Maturity Level 4, the highest possible classification in the world. Singapore is the first country in the world to attain this level for medical device regulation. This adds to the WHO recognitions HSA has been achieving over the years. This includes the highest maturity level as well for medicines, and as a Stringent Regulatory Authority for high-risk in-vitro diagnostics. Singapore now holds WHO's highest mark of regulatory excellence across a spectrum of health products, from medicines to diagnostics, to devices.

7 This is a strong affirmation of our most valuable asset - trust. Trust is the heart of what HSA does, and for the past 25 years we have earned it the only way it can be earned: through processes that are rigorous, transparent, and consistent, and through decisions that, day after day, deliver safe and high-performing products to the people who depend on them. That is what these WHO recognitions certify. What this means very simply for medical device makers and investors is that with HSA’s approval, your products will in effect get a global seal of confidence. It signals to other regulators, and health systems that your technology has been scrutinised to the highest international standards.

8 More than just an approval, this trust in turn leads to tangible speed at which you can enter markets. Specifically, through regulatory harmonisation and reliance.

Reliance Turns Trust into Time

9 Our reciprocal reliance programme with Malaysia’s Medical Device Authority was launched as a successful pilot and was fully implemented since March 2026. Since then, HSA-registered Class B to D devices enjoy a verification route with a timeline that has been halved to 30 working days, compared to 60 working days under the full route. Reciprocally, devices registered with the Malaysian authority benefit shorter review times across Class B to D devices in Singapore. The result: meaningfully reduced timelines for dual market access in two of ASEAN’s most dynamic healthcare economies.

10 We have also established reliance pathways with Thailand’s FDA, where HSA assessments of approved devices can shorten their review times significantly, from an average of 150 working days down to 60 working days. Besides these two countries, we are deepening collaboration with many other key markets you can see to the right of the slides, including Australia, as well as exploring other new markets such as China and Saudi. To date, over 450 HSA-registered medical devices have been approved through reliance pathways across Australia, Malaysia, and Thailand alone, a tangible measure of the real-world impact these pathways are already delivering.

11 In short, Singapore is becoming a high-trust regulatory gateway to regional and global markets. When you choose to anchor regulatory strategy in Singapore, you are unlocking accelerated, trusted access across multiple high-value territories.

Pillar Two: Holistic Value Proposition

12 Second, to provide a holistic value proposition by bringing together various agencies across the entire product lifecycle from clinical trial to adoption and this is where we have set up an industry development arm to see how to better engage and support the industry. Regulatory approval is necessary, but it is not sufficient. True commercial success and patient impact require that approval translates swiftly into adoption and reimbursement.

13 This is why our collaboration with the Agency for Care Effectiveness (ACE) is so important. ACE is Singapore's national health technology assessment agency, responsible for evaluating the clinical and cost-effectiveness of health technologies to guide their adoption in our healthcare system. HSA and ACE are exploring how we can better support health technologies that serve important clinical needs, and have potential value for Singapore’s healthcare system. The two agencies aim to smoothen the pathway from regulatory clearance to adoption, so that patients can get the best, cost-effective and most innovative care they need, faster.

14 But our holistic value proposition extends beyond the MOH family. For international companies looking to establish a presence in Singapore, we work closely with A*STAR to anchor translational research and industry-relevant innovation, and with the Economic Development Board to facilitate manufacturing investment, alongside HSA's rigorous yet expedient registration process. For our homegrown companies, Enterprise Singapore helps open doors to regional and global markets, while HSA provides early guidance and capability development to help you navigate the regulatory landscape with confidence. Together, we form a supportive ecosystem that supports you at every stage, whether you are setting up here, scaling up, or breaking into new markets.

15 Ultimately, what we are building is not just a regulatory gateway, but a partnership for success. HSA sits at the heart of this joined-up ecosystem, committed to playing our part not just as a regulator, but as a collaborator and enabler. Because when your innovations reach patients faster and more effectively, that is a win for your investment, business, for our healthcare system, and most importantly, for the patients whose lives you are here to transform.

Pillar Three: Adaptive Regulations

16 Third, HSA will continue to keep an adaptive approach to regulations, in order to keep pace with innovation. The most exciting MedTech innovations today, and those you are backing, are intelligent, connected, adaptive, and often powered by artificial intelligence and machine learning. This includes Software as a Medical Device, AI-driven diagnostics, digital therapeutics, and brain-computer interface implants: these demand regulatory frameworks that are equally intelligent and adaptive.

17 HSA has made it a strategic priority to be a global leader in the responsible regulation of AI-enabled medical technologies. We are building agile, risk-proportionate frameworks that provide clarity without stifling the very innovation we all want to see flourish. A key part of this effort is the refreshed Artificial Intelligence in Healthcare Guidelines, AIHGle 2.0, which we published together with the Ministry of Health to support the safe and responsible development, deployment, and use of AI across the healthcare ecosystem. AIHGle 2.0 complements HSA's regulatory framework for software medical devices, strengthening accountability by clarifying the responsibilities of developers, deployers, and users across the AI lifecycle. But guidance and frameworks alone are not enough. Companies need practical, early support. I have included a QR code in which you can scan and download a copy of the report.

Pre-market Consultation

18 That is why I strongly encourage every MedTech company and every portfolio company here to make full use of HSA's Pre-market Consultation Scheme. Since its launch in 2017, the scheme has supported a growing number of consultations with companies, averaging over 30 consultations a year, and has facilitated priority review applications. Many of these companies are involved in digital health and AI-enabled solutions. The HSA Consultation Scheme has directly helped companies strengthen dossiers, anticipate evidence requirements, and accelerate market access.

19 Come to us early with your concepts. Through HSA's Innovation Office for Medical Devices, you can share your clinical development plans, your regulatory strategy questions, your dossier drafts. The Innovation Office provides targeted, confidential guidance to help you design better studies, anticipate evidence requirements, and avoid costly rework later.

20 Early engagement with HSA is one of the highest return-on- investment activities you can undertake. It shortens development timelines, strengthens global submissions, and aims to give you a clear and well-mapped path to market.

21 This is adaptive regulation in action: forward-leaning, partnership-oriented, and designed for the technologies of tomorrow.

A New Kind of Partnership

22 HSA will continue to engage industry partners closely to ensure our regulations remain relevant and responsive to the needs of this rapidly evolving industry. Traditionally, regulators enter the picture late: after the product is built, the clinical strategy is set, and the investment is committed. We believe that model leaves value on the table. So HSA is deliberately shifting left, to be present at the earliest stages, when concepts are still being shaped and the decisions that determine the speed and success of your path to market are still open. The earlier we engage, the better the outcomes for innovators, for patients, and for us.

23 To make this shift, our people need to truly understand your world. That is why I am pleased to announce that HSA will partner with Fogarty Innovation to develop an immersion programme for our regulatory staff at all levels, including senior management. This would give regulators first-hand exposure to the startup experience and the realities of early-stage medical device development. This is modelled on Fogarty Innovation's existing longstanding collaboration with the US FDA, where immersion visits and regular industry webinars have meaningfully strengthened how regulators and the medtech community work together. Because the best regulation is not written from a distance. It is shaped by regulators who understand your world. And we are committed to building exactly that. This is the foundation on which we extend our open invitation to you.

Open Invitation to Global Venture Capital

24 You have choices about where to anchor your MedTech investments. You look for talent, clinical infrastructure, manufacturing excellence, capital markets, and government support. Singapore offers all of these at world-class standards.

25 What we at HSA add is something rarer: a regulator that understands that speed to market with quality is your competitive advantage, and that predictable, high-trust regulatory pathways are a core part of your investment thesis.

26 When your portfolio companies engage early with HSA, leverage our priority and abridged routes, tap into our international reliance networks, use our pre-market consultations, align with ACE on value for high priority products, they gain months, sometimes years, of advantage. They reduce execution risk. They strengthen their position for subsequent funding rounds and global expansion.

27 This is our vision: HSA aims to enable your investments deliver success sooner, where regulatory interaction adds momentum, and where Singapore becomes the jurisdiction of choice for MedTech ventures.

From Regulator to Trusted Partner

28 As our ecosystem continues to grow and evolve, HSA stands ready to work closely with emerging companies at every stage of their journey, bringing our full suite of tools, from pre-market consultations to priority pathways and international reliance, to help your ventures succeed.

29 And since we are in the World Cup mood now, it reminds us that no team wins because of one brilliant player alone. Championships are won because an entire ecosystem comes together.

30 MedTech innovation is no different. It also takes an entire ecosystem to produce champions:

• Our innovators and entrepreneurs are the strikers — turning bold ideas into breakthrough technologies that change lives.

• Our clinicians and researchers are the midfielders—connecting science, evidence and patient care, transforming innovation into real-world impact.

• Our manufacturers are the defenders—ensuring that every innovation is robust, reliable and trusted.

• Our VCs and investors are the club owners—providing the conviction, capital and long-term vision to build tomorrow’s champions.

• Our government agencies and ecosystem partners are the league organisers, creating a world-class environment where innovation can flourish from discovery to adoption.

• And at HSA, we are proud to play the role of the referee. Not a referee who constantly blows the whistle and stops the game—but one who understands the game, applies the rules with fairness, consistency and integrity, protects every player, and allows innovation to flow with confidence towards the ultimate goal.

31 Perhaps there is one important difference between soccer and healthcare. In soccer, every team is competing to lift a trophy. But in healthcare, we are all playing for something far greater. We are playing for the patient. That is the goal that unites every innovator, every investor, every clinician, every regulator and every partner in this room.

32 Because unlike the World Cup, where only one team becomes champion, healthcare is not a zero-sum game:

• When innovators succeed, patients benefit.

• When regulators enable trusted innovation, industries grow.

• When investors back bold ideas, healthcare advances.

When we work together as one ecosystem, team, everyone wins—but most importantly, patients win - patients win through earlier access to life-changing technologies. so let us continue to play as one team.

33 Because in the end, our greatest victory is not lifting a trophy. It is giving every patient the opportunity to live a healthier, longer and better life.

Looking Ahead: Together

34 To every innovator and investor in this room: Singapore is ready for your boldest ideas. HSA is ready to walk alongside you, as a trusted partner.

35 Let us turn regulatory excellence into patient impact at scale.

36 Together, let us make Singapore the home ground where the world’s most promising MedTech ventures are nurtured, trusted and launched responsibly, rapidly and successfully—and from here, go on to improve and save millions of lives globally.

37 Thank you.

Refer to Annex for PDF version of Presentation.

Annex

Presentation [PDF, 1.84 MB]