Regulatory Open Forum

Dear all,

Can anyone provide me with his own experience on how to obtain a NOC (No Objection Certificate) for a Medical Device in India?

Indeed, one of our MD is not on the "list of notified devices", thus not falling under regulations of CDSCO.
But it seems that having NOC in hands is a precious passport to avoid your devices to be blocked at customs.

Thanks a lot for your support
Pierre

NOC can be obtained from DCGI (Drug Controller General of India).

Contact info:
 
Drugs Controller General (India),  
Central Drugs Standard Control Organization,  
Ministry of Health and Family Welfare,  
Nirman Bhawan, New Delhi -110001.  
Phone: 91-11-23061806 
Fax: 91-11-23062648 
Email: dci@nb.nic.in

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Original Message:
Sent: 07-18-2012 06:39
From: Pierre Geens
Subject: NOC (No Objection Certificate) for Medical Device in India

Dear all,

Can anyone provide me with his own experience on how to obtain a NOC (No Objection Certificate) for a Medical Device in India?

Indeed, one of our MD is not on the "list of notified devices", thus not falling under regulations of CDSCO.
But it seems that having NOC in hands is a precious passport to avoid your devices to be blocked at customs.

Thanks a lot for your support
Pierre