Regulatory Open Forum

 View Only

  • 1.  Shonin - Japanese Medical Device Question

    Posted 23-May-2019 09:17
    This message was posted by a user wishing to remain anonymous

    I was asked this question by a colleague but as someone deeply embedded in the Pharma World, I have no idea what the answer is.

    With respect to ​​Shonin - Japan Device Submission Requirement: does the validation report [end-user testing outcome] need to be part of the Shonin submission? If needed, could the Shonin submission be amended with the validation report during review? What are the "must have" reports in a Shonin application and where are the submission requirements contents listed and are they in English?

    Thanks in advance for any assistance. Just pointing me in the right direction would be helpful.


  • 2.  RE: Shonin - Japanese Medical Device Question

    Posted 24-May-2019 08:30

    I'm not an expert on the requirements, but Pacific Bridge Medical specializes in Asian medical device registration processes. 

     

    https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/japan/

     

    This is their information page for such registrations.

     

    Andrew Andreasen

    Post Market Program Manager

    Philips Medical Systems (Cleveland), Inc.

    595 Miner Road

    Highland Heights, OH 44143

     

    Ph. 440-869-4408

    Cell 661-916-3100

     


    The information contained in this message may be confidential and legally protected under applicable law. The message is intended solely for the addressee(s). If you are not the intended recipient, you are hereby notified that any use, forwarding, dissemination, or reproduction of this message is strictly prohibited and may be unlawful. If you are not the intended recipient, please contact the sender by return e-mail and destroy all copies of the original message.



    Original Message


Related Content