【Webinar】Reimbursement and Regulatory Trends in Software as a Medical Device in Europe (Registration Now Open / Oct 20, 2025)
Event Overview
The rapid convergence of personalized precision medicine, Bio-ICT, and biomedical chip technology is redefining the global healthcare ecosystem. This transformative shift demands that medical device manufacturers rapidly adapt their business models and master increasingly complex international regulatory landscapes.
To address these strategic challenges and support Taiwan’s advanced medical equipment and software manufacturers, the Science & Technology Law Institute (STLI), Institute for Information Industry (III), in collaboration with the Medical Device Innovation Center (MDIC) of National Cheng Kung University (NCKU), and NCKU SPARK, and advised by the Department of Industrial Technology (DoIT), Ministry of Economic Affairs (MOEA), announces an essential international webinar.
This international webinar brings together leading domestic and European experts to explore the economic value, commercialization potential, and regulatory strategies of innovative medical technologies. (Youtube Livestream: https://youtube.com/live/e_dsN0LUgTw)
Featured Insights from Speakers: Decoding European SaMD Market Entry
Isaac Middelmann
Accelerator Director - Strategic Fundraising at EIT Health
Topic: Key Considerations in European Regulatory and/or Reimbursement Reviews for Software Medical Devices from an AI and Digital Perspectives
Mr Middelmann will provide a deep dive into the critical success factors and best practices for scaling innovative health technologies within the European Union's stringent regulatory environment.
Roger Chen
Founder and Director of Liwei International Ltd.
Topic: From MDR/IVDR to the AI Act: Regulatory Submission Strategy for SaMD in the EU
Mr Chen will provide expert analysis on the strategic nuances of regulatory review and reimbursement pathways, specifically for Software as a Medical Device (SaMD), under the European framework.
Key Focus Areas: Bridging the Global Regulatory Divide
The primary objective of this webinar is to facilitate a robust exchange on international development trends, offering participants concrete, policy-driven perspectives:
Global Regulatory Alignment: Analyzing the divergence and convergence of standards for high-risk medical devices across major international jurisdictions (e.g., EU MDR/IVDR, FDA).
SaMD Validation and Reimbursement: Deconstructing the financial and clinical evidence required for successful market adoption and payer reimbursement of software-only medical solutions.
Innovation Ecosystem Integration: Strategies for developing a high-value, innovation-driven regulatory ecosystem in Taiwan that is fully harmonized with leading global regulatory bodies.
This event is indispensable for regulatory affairs specialists, R&D executives, and market strategists committed to advancing Taiwan's medtech industry into a globally competitive, innovation-centric domain.
Agenda
Event Details
Date: October 20, 2025（Mon）
Time: 15:00–16:30 AM (GMT+8)
Location: https://youtube.com/live/e_dsN0LUgTw (YouTube livestream)
Registration: Please click the registration link or scan the QR code right to sign up.
Organized by
Advisory: Department of Industrial Technology, Ministry of Economic Affairs (MOEA), Taiwan, R.O.C.
Organizer: Science & Technology Law Institute, Institute for Information Industry
Executed by: AnkeCare
Co-organizer: Medical Device Innovation Center (MDIC) of National Cheng Kung University (NCKU), NCKU SPARK
Media Partners: AnkeCare, Sourcingcares
