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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

    Aug 10, 2017
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    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?
    Last edited by a moderator: May 24, 2018