Regulatory Open Forum

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  • 1.  India again

    Posted 17-Oct-2018 08:41
    Hello folks,

    I have a practical question. I know the 2017 Indian Medical Device Rules are in effect and that the 2018 Draft Guidance clarifying them is in place. So in theory everyone should be preparing submissions and sending them in even for those devices types not on the current Officially Notified Device List.

    In practice, is anyone actually doing this?  I have heard from a few people that CSDCO has asked companies not to submit because they are swamped.  Is this still correct? Is this only for certain Classes?   

    Even here on RAPS we have seen conflicting guidance so I hoping someone on the ground with experience in actually submitting or trying to submit non-notified devices can respond.

    Can a device be sold while under review if it is NOT  Officially Notified -will it make it through custins?

    What happens to devices being sold there now which are already.in-country and being sold? Do they have to stop sales?  Can they be used as a reference predicate from safety aspect if non-Notified?

    Thanks,


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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 2.  RE: India again

    Posted 20-Oct-2018 08:20
    Hi Ginger,

    I have been working with MD regulations with CDSCO and can answer your few questions:

    1.The local Indian manufacturer who have been manufacturing and supplying MD before the new 2017 law came into effect are still continuing without MD Approvals. This is allowed but it is again the responsibility of manufacturer of MD to ensure that MD Applications are applied online and approval takes place.

    2.For importers i.e. Foreign manufacturer of MD, I believe the same principle is true that they can sell the MD into India that they have been doing till now; but at the same time has to apply for MD registrations as per the new rule book. Whether the MD will be cleared from customs is not known.(But I see a rare possibility of customs not allowing the clearance).

    Although CDSCO has brought the new MD Rules 2017 into implementation via online portal however still there are lots of clarification required and approval time-lines are also not met as per the standard time-lines defines in the rule book.

    Hope this helps !

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    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
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