[Event Recap] Embracing the Smart Healthcare Era: Global Compliance Trends and Taiwan’s Strategic Response
At the Advanced Medical Technology Compliance Symposium hosted by STLI, experts highlighted how Taiwan’s alignment with international regulatory standards is accelerating the adoption of AI-powered clinical diagnostics and biomedical chips, driving safer healthcare delivery and enhancing global competitiveness.
As smart healthcare technologies rapidly evolve, the global medical sector is undergoing a major shift in regulation and market expectations. Taiwan is actively aligning with these trends while fostering a strong foundation for medical innovation.
On July 11, 2025, the Science & Technology Law Institute(STLI) of the Institute for Information Industry (III) hosted the Advanced Medical Technology Compliance Symposium, guided by the Department of Industrial Technology, MOEA, and executed by Anke Media Corp., this event bringing together legal and industry experts to explore international regulatory developments, practical framework applications, and Taiwan’s strategic path toward smart healthcare leadership.
Toward an Agile Innovation Ecosystem
Dr. Chin-Li Wang, Director General of III’s Science & Technology Law Institute, addressed in the opening remarks and emphasized that Taiwan’s edge lies in its ability to rapidly apply emerging technologies. However, success also depends on cultivating an ecosystem that supports experimentation, trust, and acceleration. He stressed the need to shift from risk avoidance to risk-managed innovation, advocating for a system that balances safety with speed and regulation with growth.
Global Trends: From Sandboxes to International Alignment
Researcher Yi Liu from STLI outlined key international trends shaping the future of smart health technologies. Countries such as the UK, US, EU member states, Singapore, and South Korea are shifting away from legacy frameworks, embracing more adaptive approaches such as testing environments and AI-specific assessment tools.
She highlighted the UK’s efforts to support AI medical technologies through programs like the AIaMD Sandbox (AI Airlock) and the AI in Health and Care Award. These initiatives help startups test and adapt their technologies within regulatory frameworks and often involve national bodies like NICE to conduct health technology assessments, paving the way for wider adoption and reimbursement in healthcare systems.
Additionally, Liu pointed out that there is growing reliance on mutual recognition and shared documentation among nations, accelerating access to global markets. Liu emphasized that Taiwan must stay in sync with these developments or risk being left behind.
TFDA Updates Guidance and Strengthens Support to Address Smart Medical Device Innovation and Compliance
Hsiang-Chin Lu, a reviewer of Artificial Intelligence Medical Device Center from Taiwan’s Food and Drug Administration (TFDA), outlined Taiwan’s comprehensive compliance framework for medical devices, emphasizing full lifecycle oversight from design, verification, market approval, to post-market surveillance. He stressed that manufacturers must carefully consider device classification and categorization when submitting registration applications.
To keep pace with the rapid advances and broad application of smart medical devices, TFDA has issued guidance on medical software classification to clarify distinctions, such as between medical software and software that is not considered a medical device, and has used wearable devices as examples to explain regulatory management differences.
To support the rapid development of smart medical devices, TFDA has issued clear guidelines to differentiate medical software from non-medical software, using wearables to illustrate regulatory distinctions. To address industry needs, TFDA has also conducted in-depth analyses and matched solutions to key challenges faced by manufacturers. In September 2024, it introduced the Pre-Determined Change Control Plan (PCCP), allowing AI/ML-based device developers to make pre-approved design changes without resubmitting applications each time.
Acer Healthcare Accelerates Care Delivery with AI Integration from Clinical Decision-Making to Medical Documentation
Edward Hsu, President and Chief Medical Officer of Acer Healthcare, shared that Acer Healthcare focuses on AI and generative AI technologies, successfully deploying them across multiple domains such as clinical diagnostics, telehealth, and structured medical record management. Notably, generative AI supports healthcare professionals in organizing medical documentation and clinical decision support, significantly reducing manual workload while speeding up patient care workflows.
Recently, Acer Healthcare has partnered with several hospitals to join Taiwan’s Ministry of Health and Welfare’s three major AI centers. These collaborations actively evaluate the clinical effectiveness and reimbursement potential of their AI-enabled products.
Hsu emphasized that industry innovation must advance in parallel with compliance readiness, with key challenges include data format standardization, platform interoperability, and massive data utilization. Addressing these requires cross-ministerial coordination and strong cooperation among government, academia, and industry stakeholders to sustain regulatory compliance and support scalable healthcare innovation.
Biomedical Chips as a Global R&D and Compliance Focus: Standardization Drives Clinical Adoption
Biomedical chips are emerging as a key focus in global R&D and regulatory strategies, valued for their potential to replace animal testing and improve drug development. According to Xin-min Wen from STLI, countries like the US, EU, China, and Japan are investing in research and the development of regulatory frameworks to support clinical integration of these technologies.
Standardization is essential to bringing biomedical chips into the medical device domain, ensuring compatibility with existing regulations. International cooperation among regulators and standards organizations aims to establish unified validation standards—accelerating approval processes and global market access.
Microfluidic Biomedical Chips Face Hurdles; MDDT Framework Offers Path Forward
Hsin-Chieh Lee, a reviewer from Taiwan’s Center for Drug Evaluation highlighted regulatory challenges for microfluidic biomedical chips. She introduced the U.S. FDA’s Qualification of Medical Device Development Tools (MDDT) guidance as a framework that could support future development of these technologies by improving efficiency and ensuring safety.
While microfluidic technologies are not yet included in the FDA’s MDDT list, their broad applications, such as personalized medicine and diagnostics, making them strong candidates. However, commercialization remains difficult due to the lack of standardized regulatory pathways.
Organ Chips: A Promising Alternative to Animal Testing
Steven Cheng from Pyhthia Biotech Ltd. discussed organ chips, which use microfluidic systems to simulate human organ environments. These chips offer faster, cost-effective alternatives to animal testing and are gaining attention in drug development and precision medicine. With the EU and US promoting alternatives to animal testing since 2020, organ chips are seen as a key solution to meet evolving regulatory demands.
Conclusion: Regulatory Innovation as a Catalyst for Smart Healthcare
The symposium showcased the intersection of global policy, Taiwan’s regulatory progress, and cutting-edge technologies. Experts agreed: Taiwan must deepen regulatory innovation, align with international standards, and support industry development to fully leverage emerging technologies like AI and biomedical chips. For Taiwan to lead in this space, its regulatory systems must shift from being gatekeepers to active partners in innovation, helping accelerate adoption and global competitiveness.
Introduction of the Science & Technology Law Institute of the Institute
In 1989, the Institute for Information Industry (III) established the “Information Law Research Task Force” within its Market Intelligence & Consulting Institute (MIC) to help Taiwan’s IT industry keep pace with global trends and increase its international competitiveness by creating a sound and comprehensive legal and regulatory environment. The creation of such an environment was aimed at stimulating the growth of Taiwan’s high-tech industries.
In 1996, with support from the Technology Development Program (TDP) run by the Ministry of Economic Affairs (MOEA), the status of the task force was elevated and it became an independent unit under the III, with the name Science & Technology Law Center (STLC) and then Science & Technology Law Institute (STLI) since 2011.
Official Website: https://stli.iii.org.tw//en/index.aspx
