Latest / Medical Device Global Market Access
Unlocking Exports: FSC Documentation by Device Class
This episode provides a detailed guide on the essential supporting documents required for a Free Sales Certificate (FSC) application. We break down the specific requirements based on medical device classification under the EU MDR, clarifying which documents, such as the Declaration of Conformity, ISO 13485, and CE certificates, are necessary for Class I, IIa, IIb, and III devices. Understand the critical differences in documentation to ensure your export applications are successful. Key Questions: • What is a Free Sales Certificate and why is it vital for exporting medical devices? • Which…
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