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White label of medical device into Japan

  • 1.  White label of medical device into Japan

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jul-2023 08:36
    This message was posted by a user wishing to remain anonymous

    Good Day,

    We have a customer who previously registered our product as theirs in Japan.  We stopped that when we incurred all the expenses related to MDR.  Our sales volume to Japan is no where near enough to in a MAH there (most every site says minimum $1mil in sales/year to break even) .  They have come back to us and asked if they could white label our product as their own in order to continue sales in Japan. 

    Our product is very minor in the scope of the very expensive equipment they sell into Japan with which you can use our product.

    Interested in pros/cons and anyone's experience with this.

    Thanks!