Navigating FDA Export Certificates: Timelines, Fees, and 2024 Updates

Medical Device Global Market Access

This episode demystifies the process of obtaining a Certificate to Foreign Government (CFG), also known as a Free Sale Certificate (FSC), from the US FDA. We cover the official timelines for issuance, the specific government fees you can expect to pay, and the critical procedural shift to electronic-only certificates that took effect in early 2024. Learn the essential details to plan your international market submissions effectively and avoid costly delays. • What is the official FDA term for a “Free Sale Certificate”? • How long does the FDA have to issue an export certificate once requested? • What is the exact government fee for the first CFG? • How much does each additional certificate from the same request cost? • Is there a page limit that could unexpectedly increase your fees? • What major change did the FDA implement for all export certificates on January 2, 2024? • How can foreign governments now instantly authenticate your certificate? • Why is this certificate a mandatory requirement for market entry in many regions? • How can you efficiently manage product lists to control costs? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.