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• Create Date November 7, 2023
• Last Updated December 1, 2023

Understanding IVD Reagents Registration Requirements: China & US Perspectives

Join our webinar to stay up to date on the changing regulatory landscape in both China NMPA and US FDA for In Vitro Diagnostics (IVD) reagents. Our expert speaker will explore the key requirements, processes, and approval criteria for reagent products in these 2 largest Medtech markets in the world.

After this 75-minute webinar you will have a practical understanding of the following areas about IVD reagents registration:

China NMPA

• General regulatory landscape of IVD reagents
• Specific IVD classification rules and registration unit division
• Registration dossier requirements and best practices
• Significant NMPA requirements that you need to comply for your type testing success
• Using Overseas Clinical Trial Data for China submission
• Regulation on human genetic resources for clinical studies

US FDA

• FDA risk classification for IVDs
• Requirements for registration and listings of IVD products
• 510K exempt devices
• Concept of general controls
• Special controls and pre-market approval

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