Hello,
As per Medical Device Rules 2017 as laid down by CDSCO, they have classified the Medical Devices as A,B & C based on risk based classifications.
The Medical Device Rule also has very clearly stated importation guidelines of MD into India. Each of the class is regulated and it requires online application as per the requirements stated in the Rule book.
The"No Objection Certificate" is not applicable at all for MD to be sold in India, both by local Indian manufacturer as well as foreign manufacturer.
The Medical Device Rule 2017 can be downloaded from the weblink given below:
http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E(1).pdfHope this helps !
------------------------------
PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
------------------------------
Original Message:
Sent: 27-Sep-2018 14:16
From: Anonymous Member
Subject: India No Objection Certificate
This message was posted by a user wishing to remain anonymous
My company is looking into selling our device in India. I have been looking into the Medical Device regulations for India, and our device is not one of the regulated Medical Devices that they list. Therefore, it is my understanding that our device would not need to be registered but would need a No Objection Certificate to import our device. Can anyone provide information on the process to obtain a No Objection Certificate from DCGI and the length of time it typically takes to obtain one?