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  • 1.  Physician's direct importing - Japan

    This message was posted by a user wishing to remain anonymous
    Posted 23-Dec-2019 12:07
    This message was posted by a user wishing to remain anonymous

    Hi,

    Does anyone know about Japan regulation where a Physician can directly import a medical device which is not yet licensed in Japan?
    I want to know under which Japan regulation is this authorization provided and what are the incident reporting requirements.

    Any guidance is highly appreciated!

    Thanks in advance!


  • 2.  RE: Physician's direct importing - Japan

    Posted 24-Dec-2019 11:18
    Yes, I have done this in my past, please reach out to me directly via email at wfj0419@gmail.com or call me at 510-574-5454.

    Best regards,

    Bill J

    ------------------------------
    William Jackson
    President
    Broomfield CO
    United States
    ------------------------------

    Original Message


  • 3.  RE: Physician's direct importing - Japan

    This message was posted by a user wishing to remain anonymous
    Posted 26-Dec-2019 15:07
      |   view attached
    This message was posted by a user wishing to remain anonymous

    Hi,

    My company uses that model for Japan under MHLW 11301, Guidelines for Pharmaceutical Products and Poisonous and Deleterious; refer to document attached. Under this model, it is the physicians own responsibility to inform the manufacturer about any incidents.

    Hope this helps!
    Original Message


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