Hi Frank
Free Sales Certificates are the European counterpart to FDA Certificates of Free Sale for products cleared in the US,
They are requested by your European Authorized Representative (EAR) to the Competent Medical Authority for that country. The link contains the list of Competent MEdical Authorities.
https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-humanMy understanding is that the location of your EAR determines what country can issue the FSC.
Good luck!
------------------------------
Jean Bigoney PhD, RAC, CQE
Regulatory Affairs Specialist
Morrisville NC
United States
------------------------------
Original Message:
Sent: 25-Apr-2019 04:42
From: Frank Wilmerstaedt
Subject: who issues free sales certificates for medical devices in france
Hi RapsCom,
does anybody has information who issues free sales certificates for medical devices in france?
Best regards
------------------------------
Frank Wilmerstaedt
General Manager QA/RA
------------------------------