Regulatory Open Forum

 View Only
  • 1.  Unable to request EU CFS

    Posted 12-Dec-2013 03:46
    --All:

    I am wondering if anyone can help me with a question I recently encountered.

    Our company recently requested for an EU CFS for a medical device made in the USA. This medical device is CE marked and there is a European Representative. It can also be distributed in EU. The manufacturer told us it is impossible for the European Representative to issue an EU CFS, but because this message was passed to me through too many people, a clear explanation was not provided. I am surprised to hear this. Has anyone encounter a similar situation before? How do you have medical device free for sale in EU when Free sale certificate is not available? Is there other document/certificate they use instead? Thanks.


    -------------------------------------------
    Ann Lee
    Tze-Chiang Foundation of Science & Technology
    Hsin Chu
    Taiwan
    -------------------------------------------


  • 2.  RE:Unable to request EU CFS

    Posted 13-Dec-2013 09:15
    Dear Ann,

    CFS cannot be issued by a company or EU representative itself but need to be issued by the authorities. The EU representative would normally apply for a CFS in the EU member state in which it is established. It depends on the member state concerned if they issue CFS. Some do, some don't.

    Best regards,
    Erik

    -------------------------------------------
    Erik Vollebregt
    Partner
    Axon Lawyers
    Amsterdam
    Netherlands
    -------------------------------------------








  • 3.  RE:Unable to request EU CFS

    Posted 23-Dec-2013 12:04

    The CFS has to be issued by the competent authority (ministry of health) of the country where the Legal Manufacturer (that appears on the labeling) resides.

    -------------------------------------------
    Gadi Shtepel
    Gadi Shtepel Ltd.
    Sgula
    Israel
    -------------------------------------------








  • 4.  RE:Unable to request EU CFS

    Posted 13-Dec-2013 09:21
    Hi Ann Lee,
    Our company was able to obtain a Certificate of Free Sale from EU for a product made in the US only because our company has a presence in EU and could state that there is some oversight of the product that happens in Europe.  I hope this is helpful.

    -------------------------------------------
    Sarah Parsons RAC
    Associate Director Regulatory Affairs
    Janssen Diagnostics
    Rochester NY
    United States
    -------------------------------------------








  • 5.  RE:Unable to request EU CFS

    Posted 13-Dec-2013 09:27

    Hi Ann,

    Medical devices that are notified within the EU are in free circulation within the EU. This means that trade of medical devices within the EU to other European countries can be done without restriction (although some local charges may still apply).

    When exporting medical devices from the EU to a third country a Certificate of Free Sale (CFS) might be asked to provide to the government of that third country. The CFS contains a declaration from the government in which the manufacturer resides that the applicable product(s) are in free circulation within the EU and that it may exported outside the EU.

    A CFS therefore only can be issued for EU based manufacturers by their national competent authority.

    US based manufacturers can ask FDA to issue a FDA Export Certificate. See the following link for more information:

    http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm

    I hope this helps Ann.



    -------------------------------------------
    Paul Kooijmans
    Regulatory Affairs manager
    Eurotrol B.V.
    Ede
    Netherlands
    -------------------------------------------



  • 6.  RE:Unable to request EU CFS

    Posted 13-Dec-2013 10:06


    -------------------------------------------
    Ponzelle Royster RAC
    Duluth GA
    United States
    -------------------------------------------

    As a US manufacturer of CE marked devices, we have obtained a legalized Free Sales Certificate through our Authorized Representative MDSS indicating that the devices in the scope of the registration are freely marketed in Europe. I think the issuance and legalization is country specific but Germany does issue FSCs. Some countries outside the EU and US require FSC as part of the registration. It is a relatively simple process.





  • 7.  RE:Unable to request EU CFS

    Posted 13-Dec-2013 10:25
    As an example, here is how to apply for CFS in UK.

    http://wp.me/p33LGu-20X

    In UK, it is free.  

    -------------------------------------------
    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
    -------------------------------------------








  • 8.  RE:Unable to request EU CFS

    Posted 15-Dec-2013 21:40
    Dear All:

    Thank you for your helpful answers. The contact for the manufacturer facility told me she believes the European representative is based in UK. I got mixed responses for UK. Can you issue an UK CFS for medical device NOT manufactured in the UK? If so (or not), can anyone point me to the regulation or guidance that says so? I've been googling for over an hour but all I found was"They are issued in response to requests from the authorities (customs etc.) of the importing country who are seeking declarations that "the medical devices conform to the same quality and safety standards that apply in the United Kingdom and the rest of the European Union".

    I think some of you are wondering why I need an EU CFS for a US-made device. In Taiwan, we can apply for medical device via the simplified method if we have both a US CFG and an EU CFS. The functional, biocompatibility, sterilization, final QC can be exempt. In case you are interested in this, feel free to contact me.

    Thanks in advance for your answers and best regards, 


    -------------------------------------------
    Ann Lee
    Tze-Chiang Foundation of Science & Technology
    Hsin Chu
    Taiwan
    -------------------------------------------