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Session 4: The Regulatory Maze: Mapping Pathways to India, EU, and US Market Access
Session Chair(s)
Sinto Poulose
Director
IQZYME MEDTECH PVT. LTD , India
Session Focus: A practical navigation session on US FDA, EU MDR, and India’s CDSCO regulatory routes—how to choose the right pathway, avoid common and avoidable delays, and build a regulatory strategy aligned with your product type, risk class, and target market timelines. Expect concrete do’s and don’ts from real submissions, approval journeys, and market-entry playbooks across mature and emerging markets.
Speaker(s)
Introduction to FDA CDRH and Medical Devices
Pooja Jani
U.S. FDA, India
Medical Officer, Diagnostic Data Program,(CDRH)
Keynote Presentation
Aseem Sahu
CDSCO Office, India
Deputy Drugs Controller
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