CE Marked product considered a Drug in India

divyag

Starting to get Involved
#1
Dear All,

One of our medical device which is CE marked is considered as drug in India. However similar device in India is considered as Device. When we approached the regulators with the information, they asked us to file it in the drug portal rather than medical device.

The product is hydroxypropyl methylcellulose 2% gel, sterile. Need your suggestion..

what do you suggest?
 
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