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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)
Pooja Jani
Medical Officer, Diagnostic Data Program,(CDRH), U.S. FDA, India
Introduction to FDA CDRH and Medical Devices
Aseem Sahu
Deputy Drugs Controller, CDSCO Office, India
Keynote Presentation
P. S. Chandranand
Consultant – WHO Prequalification; Director, Iqzyme Medtech Pvt. Ltd, India
Moderator- Panel Discussion
K Sujith Kumar
Drug Controller & State Licensing Authority, Kerala, India
Sreejith Viswam
Director- Quality and Regulatory Stryker Global Technology Centre and APAC NPD , Stryker, India
Wil Vargas
International Regulatory Policy Analyst, CDRH, US FDA, India
Stephanie Shedd
International Regulatory Policy Analyst, CDRH, US FDA, India
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