Device Classification - India CDCSO - How to classify the device?

#1
Hi,

I am new to this forum as well as to the regulatory field. I am trying to understand and implement the regulatory process for my organization and I hit a road block in something. I thought I could post the doubt here and some of you could guide me.

As part of a self project, I am trying to classify various medical devices according to the Device Classification of the Indian Medical Devices Rules issued by CDSCO. Even though few things are confusing for a newbee like me, I could follow through on most of the points. However, when I try to classify "Drop Count monitoring" medical device - I am confused if it would fall between Class A or Class B.

Can someone help me understand how it can be classified if so what is the rule behind it? There is no predicate device identified that got approved from the CDSCO or I am missing something. Any suggestions will be helpful for me to learn a lot regarding the Indian Medical Devices Rules.

Thank you,
 

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