India New Class C? Medical Device

PharmaBro

Registered
We have a medical device that is deemed Class III in the U.S., but has not received approval yet. In pursuing market approval for India, what is the likelihood/expectation that they will ask us to conduct an additional clinical trial in India? Would it be possible to avoid having to do this?

All of our clinical trials have been based in the U.S. so far.

Appreciate any input
Thanks!
 
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