FDA Export Certificates: Navigating Apostille and Legalization Requirements

Medical Device Global Market Access · Sep 11, 2025 · 3m

This episode demystifies the critical process of authenticating FDA export documents, such as the Certificate to Foreign Government (FSC/CFG), for international markets. We explore the difference between an apostille and full legalization, explain why foreign regulators require this step, and detail the impact of the FDA's transition to electronic certificates as of January 2, 2024. Learn the new rules and procedures to ensure your medical device shipments aren't delayed at the border. Key Questions: • What is the difference between an apostille and legalization? • Which countries require an…