Latest / Medical Device Global Market Access
Your Product's Passport: Unlocking Global Sales with an FSC
In this episode, we demystify the Free Sales Certificate (FSC), a critical document for medical device and IVD manufacturers aiming for international expansion. We explore what an FSC is, why it's a mandatory requirement for registration in many countries across Asia, Latin America, and the Middle East, and how it serves as proof of regulatory compliance in your home market. The host explains who issues these certificates in key regions like the EU and the US, and discusses recent changes under the EU MDR that impact all manufacturers. Key Questions: • What is a Free Sales Certificate and why…
The skinny
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