From May 21 to 23, Duke Kunshan University hosted the core module of the CREATInG Initiative – “Meeting ISO 13485 Requirements for IVD” As the second functional training following last November’s session on regulatory affairs. This module zeroed in on implementing ISO 13485 standards, building risk-based quality management systems, and gearing up the companies for regulatory inspections – all aimed at helping companies fine-tune their quality systems and sharpen the competitiveness in the global market.
The CREATInG Initiative was launched in 2024 as a joint effort by the Duke-NUS Medical School Centre of Regulatory Excellence (CoRE) and Duke Kunshan University, with the support of the Gates Foundation. Through capacity-building training in strategic leadership, regulatory affairs, quality management, and market access, the initiative engages different roles including executives and functional professionals. It aims to help companies align with international regulatory requirements, enhance their global competitiveness, and ultimately enable more high-quality, affordable IVD products to reach underserved populations in low- and middle-income countries, advancing the vision of global health.
More than 35 participants from China and Indonesia joined the training, representing IVD manufacturers, contract manufacturers, and third-party organizations. They hold key roles in R&D, regulatory affairs, or quality management within their organizations. The session was also attended by three Sr. Program Officers from Gates Foundation – Amy Steadman, Yang Min and Bai Yujing.
Over two and a half days, the course adopted the Duke-NUS Medical School team-based learning model, including case discussions and group collaborations, helping participants enhance their practical capabilities in quality management systems from a global perspective. The training was led by Ms. Hwee Ee Tan, founder of DH RegSys, who brings over 30 years of experience in quality system regulation and regulatory affairs. She provided a systematic interpretation of ISO 13485 requirements – from clauses to application – and used real-world case studies to help participants identify and resolve non-conformities in system operations. The training also integrated international regulatory frameworks such as IVDR and MDSAP, sharing key considerations and lessons learned for compliance and inspections.
In addition, the course featured two webinars open to a broader audience of domestic and international companies and industry stakeholders. Over 50 online participants from IVD companies, investors, and research institutions across the ASEAN region and China joined the sessions.
Ms. Annie YIN, Vice President of Roche Diagnostics China, delivered a keynote presentation at the first webinar on “Updates on Good Manufacturing Practice (GMP) for Medical Devices.” She provided the interpretation of the GMP requirements issued by China National Medical Products Administration (NMPA) at the end of 2025, focusing on key changes and alignment with the global frameworks. The webinar also included a panel discussion featuring Mr. LI Yuchen, Marketing Director of ZYBio MedTech, who further explored the far-reaching implications of quality compliance for sustainable business operations, market access, and corporate brand value.
The successful conclusion of this training also lays a solid foundation for the third functional training session planned for the second half of 2026. The CREATInG Initiative will continue to connect global high-quality resources to accelerate IVD companies on their path to global markets.
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Upcoming Training – Second Half of 2026
The CREATInG Initiative plans to launch a market access and regulatory forum and its third functional training from November 8-10, 2026, at Duke Kunshan University. For more information, please follow updates from the DKU Global Health Program WeChat account. For registration inquiries, please contact Cici Yan at mengxi.yan@dukekunshan.edu.cn
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About the CREATInG Initiative
The CREATInG Initiative was launched in 2024 as a joint effort by the Duke-NUS Medical School Centre of Regulatory Excellence (CoRE) and Duke Kunshan University, with the support of the Gates Foundation. The program convenes global experts and industry leaders to strengthen regulatory and market access for affordable IVD solutions in low- and middle-income countries through international conferences, executive training, and capacity-building programs.
Learn more: https://www.duke-nus.edu.sg/core/think-tank/gates-core-and-duke-kunshan-regulatory-strengthening-project
Article | Zhangyang Pan
Editor | Mengxi Yan, Yijie Nan
