Regulatory Open Forum

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  • 1.  Distributor

    Posted 19-Mar-2019 14:36
    Hello Everyone,

    Can you ship a medical device to your distributor in a country where it doesn't meet the regulation, solely to be shipped to another country where it meets the regulations?
    Direct shipping isn't feasible because of the logistics.
    Thank you for your advice in advance.


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    Sheemah Kazi
    QA/RA coordinator
    Concord CA
    United States
    ------------------------------


  • 2.  RE: Distributor

    Posted 20-Mar-2019 05:41
    ​Hi Kazi
    Can I please ask what countries are they?

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    Larisa Caplin
    United Kingdom
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    Original Message


  • 3.  RE: Distributor

    Posted 20-Mar-2019 12:11
    Hi Larisa,

    The distributor is in EU and the device is to be shipped to India.

    Thanks,
    Sheemah

    ------------------------------
    Sheemah Kazi
    QA/RA coordinator
    Concord CA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Distributor

    Posted 20-Mar-2019 12:49
    ​Dear Kazi
    Ok, so from a regulatory perspective we need to be sure that you have a valid MA( market authorisation) IN India.
    As per EU an logistics, there must be a shipment agreement in place indicating that the product will not be distributed in EU.
    Have you spoken with the logistic company?

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    Larisa Caplin
    United Kingdom
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    Original Message


  • 5.  RE: Distributor

    Posted 20-Mar-2019 13:01
    Edited by Sheemah Kazi 20-Mar-2019 13:09

    Hi Larisa,

    Yes we have an MA in India and as yes we do have an agreement stating the product will not be distributed in EU.
    My concern is will shipping to "EU" will be considered in placing it in the market?



    ------------------------------
    Sheemah Kazi
    QA/RA coordinator
    Concord CA
    United States
    ------------------------------

    Original Message


  • 6.  RE: Distributor

    Posted 20-Mar-2019 13:11
    Might be possible, others have good comments, but also it may get blocked in Customs if there is no proper authorisation or documentation.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 7.  RE: Distributor

    Posted 21-Mar-2019 12:09
    Thanks Richard!

    ------------------------------
    Sheemah Kazi
    QA/RA coordinator
    Concord CA
    United States
    ------------------------------

    Original Message


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