Regulatory Open Forum

 View Only

  • 1.  PMS & Customer Handling Requirements for Brazil & Japan

    Posted 10-Jun-2021 00:08
    Need some reference material for the PMS, Regulatory Reporting requirements and Compliant Handling requirements for ANVISA (Brazil) & PMDA (Japan).

    ------------------------------
    Anirban Banerjee
    L&T Technology Services Limited
    Bangalore
    India
    ------------------------------


  • 2.  RE: PMS & Customer Handling Requirements for Brazil & Japan

    Posted 23-Jun-2021 10:15
    Emergo has a reference
    https://www.emergobyul.com/services/brazil/medical-device-vigilance-reporting-anvisa-brazil

    I found multiple links to PMDA resources through a google search using terms "PMDA post-market surveillance"
    Jackie

    ------------------------------
    Jackie Jaskula
    Regulatory Affairs Manager
    OrthoPediatrics
    Warsaw, IN
    USA
    ------------------------------

    Original Message


Related Content