Email: cs@nedystec.com
A Certificate of Free Sale (CFS) is a crucial document for manufacturers and authorised representatives exporting medical devices outside the EU. Issued under Article 60 of Regulation (EU) 2017/745 (MDR), it confirms that the device complies with EU regulatory requirements, bears the CE marking, and may be lawfully marketed within the EU.
A CFS simplifies the export of medical devices to countries requiring evidence of EU regulatory compliance and marketability.
It provides foreign authorities with formal confirmation that the device meets all applicable EU safety and performance requirements.
This document supports and accelerates product registration and market entry in multiple non-EU jurisdictions.
Assist you in preparing FSC certification application documents
Guide compliance with EU FSC forest management standards
Liaise with certification bodies to advance audit processes
Provide certification compliance consulting and post-certification maintenance support
Expert Guidance on EU Standards: We provide professional guidance to ensure your full compliance with EU FSC standards and regulatory requirements.
Direct Liaison with Certification Bodies: We offer dedicated coordination with certification bodies to help speed up your audits and approval processes.
Time and Cost Efficient: We use streamlined procedures to reduce your preparation time, avoid delays, and lower your overall certification costs.
Proven Track Record: We have successfully assisted 30+ clients in obtaining official Free Sale Certificates with high approval rates.