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  • 1.  PMD Act - Japan

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

    Hi 

    Does anyone know where I can download (or view) the Japanese PMD Act?  I am having trouble locating the actual document.

    Thanks in advance



  • 2.  RE: PMD Act - Japan

    Posted 22-Jun-2023 00:26

    You can download PMD Act from e-Gov. Here is the link: https://elaws.e-gov.go.jp/document?lawid=335AC0000000145



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    Takefumi Gemba
    Global Regulatory Affairs
    Japan
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    Original Message


  • 3.  RE: PMD Act - Japan

    Posted 22-Jun-2023 00:33

    Revision of Japanese Medical Device QMS requirements | Pharmaceuticals and Medical Devices Agency (pmda.go.jp)

    Page contains links to tentative translations to Chapters 3-4-5.

    Gert Sorensen

    Quality-Audit.eu



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    GertSørensen
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    Original Message


  • 4.  RE: PMD Act - Japan

    Posted 22-Jun-2023 01:23

    Here you go

    https://www.pmda.go.jp/english/review-services/regulatory-info/0002.html

    Best Regards,

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


  • 5.  RE: PMD Act - Japan

    Posted 22-Jun-2023 05:21

    Hi, here is the web link to the Japanese PMD Act with English translation.

    医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 - 日本語／英語 - 日本法令外国語訳DBシステム (japaneselawtranslation.go.jp)



    ------------------------------
    Toru Murakumo RAC
    Director, Regulatory Science Department, EPS Corporation
    Japan
    murakumo.toru887@eps.co.jp
    ------------------------------

    Original Message


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