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 I know the 2017 Indian Medical Device Rules are in effect and that the 2018 Draft Guidance clarifying them is in place.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------------------------------