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 two documents are fundamental to nearly every FSC application, regardless of class?
• Is a Notified Body CE Certificate a mandatory submission for all device classes?
• How do the documentation requirements for a Class I device differ from a Class IIb or III device?
• What specific proof of a Quality Management System do authorities expect?
• Can a certificate from the old Medical Device Directive (MDD) still be used for an FSC application today?
• Which government body is responsible for issuing the FSC?
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 info@pureglobal.com for tailored support.
