Regulatory Open Forum

 View Only

  • 1.  Japan - Multiple MAHs for foreign manufacturers?

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2023 09:04
    This message was posted by a user wishing to remain anonymous

    We are a medical device manufacturer located in the USA.
    We have one of our distributors who is the Market Authorization Holder in Japan. Our labels, user manual, packaging, etc, all have the MAH's name and address listed.
    If we partnered with another distributor, can THEY also be the Market Authorization Holder in Japan? How does that work? Or can there only be one?


  • 2.  RE: Japan - Multiple MAHs for foreign manufacturers?

    Posted 30-Jan-2023 03:33
    Yes, you can have more than on distributor in Japan, even for the same medical device. Each distributror has to be authotized by his Authorithy in Japan and therefore obtain a MAH Licence. 
    It is sufficient to indicate the MAH´s name and address only on the prodcut labels. The distributor can do it himself after receiving the device in Japan.

    ------------------------------
    Agnieszka Fronczak
    Regulatory Affairs Manager
    Neu-Ulm
    Germany
    ------------------------------

    Original Message


Related Content