The Symposium on Legal Compliance for Advanced Medical Technology Products was held last week at the NTU Hospital International Convention Center. This event, organized by the Science & Technology Law Institute (STLI) of the Institute for Information Industry under the guidance of the Department of Industrial Technology, Ministry of Economic Affairs, focused on two main topics: smart medical devices and biomedical chips. Approximately 150 participants from the medical device industry, research institutions, government agencies, and industry associations attended the event to exchange views and ideas on regulatory challenges and responses in light of emerging global regulatory trends.
Dr. Wang Chin-Li, Director General of the STLI, commented on the healthcare reform driven by innovative forces such as AI and digital technology. He said: “We are standing at a crossroads of structural transformation in the healthcare system, where traditional regulatory frameworks are no longer able to keep pace with the rapid development of modern medical technologies. Innovations such as smart medical devices, digital health, and biomedical chips are not only reshaping clinical diagnosis and treatment methods but also posing significant challenges to existing regulatory structures.” Dr. Wang suggested that Taiwan should leverage its strengths in information and communication technology, as well as its healthcare industry, to become not only an active participant but also a leader in global regulatory innovation.
In the session on “Smart Medical Devices and Digital Health”, Ms. Liu Yi, a researcher at the STLI, presented the latest global regulatory trends and various AI sandbox initiatives. Mr. Lu Chiang-Jin, a reviewer at the TFDA, shared experiences and case studies related to the review of smart medical devices. Mr. Hsu Kai-Cheng, General Manager of Acer Medical Inc., offered insights into the key technologies behind digital healthcare products and shared his experience in obtaining international certification. He emphasized the importance of integrating ICT strengths with regulatory compliance thinking in order to pave the way for the future of smart healthcare products.
In the discussions on biomedical chips, Mr. Wen Hsin-Min, a researcher at STLI, shared the biomedical chip policies adopted by several advanced countries, including the EU, the US, China, and Japan. He also presented his observations on the challenges and obstacles of positioning biomedical chips as medical devices from a policy perspective. Ms. Le Hsin-Jei, a reviewer at CDER, provided an analysis of regulatory management for microfluidic chips. Dr. Cheng Ching-Chia, a postdoctoral researcher at Utai Life Science, shared his insights on the global market and clinical applications of organ-on-a-chip technology, highlighting both innovative breakthroughs and practical challenges in clinical use through cellular research.
The organizer, STLI, is committed to bridging policy and practice by supporting the government in integrating resources across different agencies and guiding the industry's compliance transformation. This symposium served as a regulatory compliance platform for all stakeholders, with the aim of creating a health technology ecosystem supported by innovative regulations that encourage R&D, facilitate clinical applications, and enhance global competitiveness.
【2025-07-18 / Central News Agency】
