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  • 1.  who issues free sales certificates for medical devices in france

    Posted 25-Apr-2019 04:43
    ​Hi RapsCom,

    does anybody has information who issues free sales certificates for medical devices in france?

    Best regards

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    Frank Wilmerstaedt
    General Manager QA/RA
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  • 2.  RE: who issues free sales certificates for medical devices in france

    Posted 26-Apr-2019 04:16
    Dear Frank

    A FSC (French: CLV, Certificat de libre vente) is issued by the Chamber of Commerce in Paris (Chambre de Commerce et de l'Industrie de la région Paris Ile de France (CCIR Paris Ile de France). 
    http://www.entreprises.cci-paris-idf.fr/web/international/certificat-libre-vente

    Kind Regards

    ------------------------------
    Nicole Gabathuler
    confinis ag
    Sursee
    Switzerland
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  • 3.  RE: who issues free sales certificates for medical devices in france

    Posted 29-Apr-2019 03:25
    Thanks Nicole, perfect link!
    BR
    Frank​

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    Frank Wilmerstaedt
    General Manager QA/RA
    Wentorf bei Hamburg
    Germany
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  • 4.  RE: who issues free sales certificates for medical devices in france

    Posted 26-Apr-2019 06:30
    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-human

    My understanding is that the location of your EAR determines what country can issue the FSC.

    Good luck!

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    Jean Bigoney PhD, RAC, CQE
    Regulatory Affairs Specialist
    Morrisville NC
    United States
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