Regulatory Open Forum

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  • 1.  Free Sales Certificate

    Posted 16-Dec-2013 10:44

    A European Free Sales Certificate 
    (FSC) is issued by the Competent Authority of the EU member state where the "manufacturer" in Europe or his authorized representative (EC REP)  has a registered place of business. If the manufacturer is not located in Europe, the Authorized Representative can obtain the FSC on behalf of the manufacturer.

    We are a US manufacturer and I have obtained several country specific FSCs via our Authorized Representative from the Competent Authority for the purpose of registration. One of the countries was Taiwan. 

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    Ponzelle Royster RAC
    Duluth GA

    United States

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  • 2.  RE:Free Sales Certificate

    Posted 17-Dec-2013 06:09

    We have found that just being the EC rep is not sufficient to obtain a UK CoFS. The product has to be made or distributed by a UK based site.



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    Dean Heit
    Biomet UK Healthcare Ltd.
    Bridgend
    United Kingdom
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  • 3.  RE:Free Sales Certificate

    Posted 18-Dec-2013 03:38
    Hi Dean, this requirement of local manufacturing is an important difference between EU member states. The Dutch, for example, do not require manufacturing in the Netherlands. It's sufficient for them if the EC rep is established in the Netherlands.

    Best regards,
    Erik

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    Erik Vollebregt
    Partner
    Axon Lawyers
    Amsterdam
    Netherlands
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  • 4.  RE:Free Sales Certificate

    Posted 19-Dec-2013 12:32
    Apparently, there are differences between EU member states in reference to obtaining a CFS.  The ones that I obtained were processed by a German Competent Authority and were acceptable for several countries for purposes of registration.

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    Ponzelle Royster RAC
    Duluth GA
    United States
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  • 5.  RE:Free Sales Certificate

    Posted 23-Dec-2013 12:03
    In Belgium, I got the response form the competent authority that the CE certificate is the one giving the free sales. Perhaps not the best, I was bale to get a document from the Chamber of Commerce that I used together with the CE certificate. The product was manufactured in Japan, but the EU office was the responsible manufacturer for the EU.
    This experience is now 5 years old.

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    Patrick Manouvriez
    MP.QRA Services Sprl
    Péruwelz
    Belgium
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