Opening Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, at the 29th Session of the International Medical Device Regulators Stakeholder Forum, 10 March 2026

Distinguished guests

Ladies and gentlemen

Good morning.

1     A very warm welcome to Singapore. It’s wonderful to see colleagues and friends from across the globe gathered here for this important IMDRF meeting.

2     I would like to extend our deepest gratitude to our guest of honour, Minister for Health and Coordinating Minister for Social Policies, Mr Ong Ye Kung, for taking time from your exceptionally busy schedule to grace this occasion with your presence. Your participation today underscores Singapore's unwavering commitment to advancing international medical device regulation and our dedication to fostering global collaboration in this critical field.

3     Today's gathering represents far more than a routine meeting—it is a pivotal opportunity to strengthen our collective efforts in harmonising medical device standards globally. Through IMDRF, we continue to build meaningful bridges between regulatory systems, fostering innovation whilst ensuring that patient safety remains the cornerstone of everything we do.

4     Yesterday, at our first day, we featured comprehensive discussions on the IMDRF Reliance Playbook, bringing together regulators, industry leaders, standards organisations, and international bodies. Sessions covered the Playbook's evolution and core principles, real-world implementation challenges, and practical experiences from regulatory authorities and industry. Other key topics included managing product changes throughout device lifecycles, embedding reliance in post-market activities through the Medical Device Single Audit Program (MDSAP) and ISO 13485 audit programmes, and strengthening adverse event reporting practice.

5     We have also heard from WHO yesterday about the global foundations of good reliance practices and how they synergise with the IMDRF Reliance Playbook, including valuable insights from the Global Benchmarking Tool+ assessment of medical device regulatory systems. Building on those discussions about strengthening regulatory frameworks worldwide, I shall not steal the thunder from our distinguished guest of honour, Minister Ong, who will shortly be sharing some very exciting developments by the Health Sciences Authority, Singapore that demonstrate how these principles translate into real achievements.

6    This exemplifies precisely the kind of collaborative progress we strive to achieve together—meaningfully reducing regulatory burden whilst maintaining the highest standards of safety and efficacy that our patients deserve.

7     Beyond regulations of new healthcare innovations and supporting industry innovation, HSA is also actively harnessing artificial intelligence to enhance our regulatory processes. We are proud to announce the launch of HSA's AI-enabled Medical Device Risk Classification Tool, which is now available in beta-testing for industry partners to trial and pilot on. This innovative tool leverages AI capabilities to provide automated guidance on preliminary risk classification to companies during their product development journey. This initiative represents HSA's commitment to being not merely a regulator of AI technologies, but also a progressive adopter of these technologies to better serve industry and, ultimately, the patients who depend on these life-changing devices. I will be sharing more of these at the fireside chat later. 

8    As we move forward, HSA remains committed to deepening our collaboration with industry partners to implement additional AI solutions that will further enhance our regulatory efficiency and create greater value for stakeholders. We recognise that regulatory authorities globally are also embracing AI technologies, and we believe there is tremendous opportunity for regulators to exchange best practices and share innovative tools with one another. This spirit of collaboration and knowledge-sharing will be essential as we collectively advance our regulatory capabilities and better serve the patients and communities we protect. 

9    I just want to end off with a quote that I read before – “the future of healthcare will not be shaped by innovation alone, but by the wisdom with which we govern it. In fact, good regulators are the architects of the future and smart regulators enable the future to arrive safely” and with that, I wish all of you a very fruitful and insightful forum ahead. 

Thank you.