Medical Device Registration and CDSCO Approval in India

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

Medical Device Regulations and Classification in India

 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.

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