Regulatory Open Forum

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  • 1.  Indian MDR 2017, classification, registration

    Posted 05-Aug-2022 02:09
    Dear all,

    i am searching for the Indian original MDR 2017 regulation,
    but i have trouble finding it. Does anyone here know where to find the latest version and could share a link?

    Also, if anyone has infomation about the classification process and more important - which regustration process is applicable for which class of medica devices, that would be great.

    Happy Friday
    Lutz

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    Lutz Babilon
    Director QM/RA
    Freiburg im Breisgau
    Germany
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  • 2.  RE: Indian MDR 2017, classification, registration

    Posted 11-Aug-2022 06:19
    You should find it under the gazzette notifications here: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/

    Need to translate it though...

    -Hannes

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    Hannes Hyvonen
    RA Manager at Icare Finland
    Vantaa
    Finland
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