India
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application. 

REGULATORY AUTHORITY:
Medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO).

CLASSIFICATION SYSTEM: List issued by CDSCO: Classes A, B, C and D, where a Class A device is low risk and a Class D device is a high risk. 

TIMEFRAME: Approval takes nine months from the date of application. 

LICENSE VALIDITY: Licenses issues in India are valid for three years.
 
AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in India.

Last updated on January 9 2018.



Interested in obtaining fast market approval for your medical device or IVD in India? REQUEST A FREE QUOTE>
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