Recently, Ms. Huang Haiyan, VP of Operations at GenDx Biotech Co., Ltd., was invited to attend the CREATInG Initiative IVD Regulatory Management Functional Training co-launched by the Duke-NUS Medical School Centre of Regulatory Excellence (Duke-NUS CoRE) and Duke Kunshan University. This in-depth participation in the world-class regulatory training is not only a key initiative of GenDx to focus on compliant development in the IVD field, but also demonstrates the company's high attention to global regulatory standards and the construction of quality management systems.
The CREATInG Initiative series of training is a high-level capacity-building program designed for professionals in IVD regulatory decision-making and manufacturing. Leveraging the academic resources and global influence of Duke-NUS CoRE, the training is co-developed with Duke Kunshan University. It aims to strengthen the technical regulatory knowledge of functional leaders in the industry and help enterprises accurately grasp regulatory requirements throughout the full product R&D lifecycle.
Workshop A, a key part of the training, focused on IVD regulatory frameworks and requirements. It covered critical content such as regulatory differences across major markets including the US, EU, and ASEAN, product risk classification, and lifecycle management. The faculty consisted of top global experts in IVD regulation, including WHO prequalification assessors, senior experts from regulatory authorities in Singapore and China, and industry veterans. They provided participants with cutting-edge perspectives that combine theoretical depth and practical value.
Against the backdrop of accelerated innovation and tightening regulation in the global IVD industry, the importance of this training is self-evident. IVD products are directly related to the accuracy of clinical diagnosis and patient safety. Regulatory compliance throughout their lifecycle is a core prerequisite for enterprises to gain a foothold in the market. Especially in major markets such as the US, EU, and ASEAN, the frequent updates of regulatory policies have raised higher requirements for enterprises' compliance capabilities.
For GenDx, this training built a bridge to connect with global top regulatory expertise. It helps the company accurately grasp international regulatory trends and industry development directions, providing authoritative guidance for compliance management across the entire chain of product R&D, manufacturing, and market access.
The training content was both systematic and practical, fully covering core points of IVD regulation and quality management:
• Regulatory Framework: In-depth interpretation of regulatory differences across major markets (US FDA, EU IVDR, ASEAN), dossier format requirements, and the latest policy updates, helping enterprises smooth global market access channels.
• Risk and Lifecycle Management: Detailed explanation of IVD product risk classification logic, WHO prequalification requirements, key control nodes in the lifecycle, and change management practices through case studies.
• Clinical and Quality Compliance: Focus on IVD clinical performance verification standards and manufacturing practices.
• Practical Response: Sharing of regulatory inspection preparation skills, audit experience, and post-market risk-benefit assessment methods, providing practical solutions for enterprises to address compliance challenges.
This training enabled us to systematically master the core logic of global IVD regulation and advanced quality management methods. It provides important support for the company to optimize its compliance management system and enhance its competitiveness in the international market. In the future, GenDx will translate the knowledge gained from this training into practical actions. It will further strengthen regulatory compliance management throughout the product lifecycle, strictly adhere to management system requirements, and continuously improve product quality and innovation capabilities. Meanwhile, the company will actively fulfill its industry responsibilities, promote the construction of compliance culture and technical exchanges in the IVD field, empower clinical diagnosis with accurate and compliant products and services, and contribute Chinese enterprise strength to the development of global health.
