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

CLASSIFICATION SYSTEM: The Indian government has designated a specific list of notified medical devices that require registration. Invasive or implantable medical devices generally fall under this list. 

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 22 2015.



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