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Session 10, Tracks A, B: New Trends and Technologies in Medical Devices and In Vitro Diagnostics: How Regulators Embrace Innovation for Future-Proofed Regulatory Frameworks
Session Chair(s)
Viktoria Magyar, LLM, MSc
Doctoral Student, Department of Regulatory and Quality Sciences
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Duglas Rodriguez Calderon, MSc
Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence
Roche, Panama
Medical devices, including in vitro diagnostics, are some of the most rapidly evolving products in the health sector. The growing number of technologies and innovations incorporated in these products have added new challenges, not only to the medical device industry, but also to regulatory agencies in their role to ensure availability of quality and safe products. Technological advancements have demonstrated their value to tackling health issues, especially during health crises like COVID-19 pandemic, reinforcing the relevance to ensure that regulatory frameworks adopt innovation in a faster and agile way. This session evaluates these technological advancements and the regulators’ approach in adapting their regulatory frameworks to enable new solutions.
Learning Objective : - Describe approaches from regulators on innovation for medical devices and in vitro diagnostics products to ensure robust, adaptable-to-innovation regulatory frameworks
- Identify regulatory challenges and opportunities to accelerate innovation in Latin America
- Recognize the importance of international alignment on harmonization and convergence to accelerate regulatory decisions to deliver next generation medical devices and in vitro diagnostics
Speaker(s)
Advances and Challenges of Regulatory Convergence
Lucia Ayala
INVIMA, Colombia
Director of Medical Devices and Other Technologies
La Actividad Reguladora de Dispositivos Médicos y los desafíos del nuevo entorno tecnológico (Post-COVID)
Mario Cesar Muniz, DrMed
CECMED, Cayman Islands
Department Head, Medical Devices
Regulatory Approaches for Innovative Devices in the United States
Kenneth Cavanaugh, PhD
FDA, United States
Deputy Director, Office of Cardiovascular Devices
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