1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

ISO 60601-1 3rd Edition in Japan

Discussion in 'Other Medical Device Regulations World-Wide' started by Jason Smith, Aug 10, 2017.

  1. Jason Smith

    Jason Smith New Member

    Joined:
    Aug 10, 2017
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    If a medical device is registered in Japan and complies with IEC 60601-1 2nd edition and has undergone no changes since its registration, can it continue to be sold in Japan after 31st May 2017?


    I understand that FDA 'grandfather' products with this description meaning that you only need to re-test for 3rd edition if any changes are made or you need to re-register for any reason but I'm not sure if this is the same for Japan?
     

Share This Page