Regulatory Open Forum

 View Only

Japan - Multiple MAHs for foreign manufacturers?

  • 1.  Japan - Multiple MAHs for foreign manufacturers?

    This message was posted by a user wishing to remain anonymous
    Posted 2 days ago
    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?