Regulatory Open Forum

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  • 1.  Change of distributor

    Posted 21-Oct-2014 01:35
    Dear All,

    I have a favor to ask if the following market arrangement would be acceptable in the US.

    We export a medical device and IVD reagents from Japan to the US.  We recently changed the distributor from Company A to Company B.  Contract with Company A has been terminated.  On the other hand, we changed our company name from X to LSI Medience (LSIM) in April.  Consequently, Company A still has some products with the name and logo of X in their warehouse.  Information of Initial Importer and Foreign Establishment have been changed accordingly.

    Now, I would like to ask you the following questions.

    1) Is it acceptable to transfer the products with the name and logo of X from the warehouse of Company A to Company B and Comapny B sells them in the US?

    2) Is it acceptable that LSIM buys back the products with the name and logo of X from Company A and sells them to Company B?  In this case, the product itself will not be physically returned to Japan but transferred within the US.

    Your commnets will be highly appreciated.

    With best regards,

    Toru


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    Toru Murakumo RAC
    General Manager, Regulatory Affairs
    LSI Medience Corporation
    Tokyo
    Japan
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