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, 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), functioning under DGHS (Directorate General of Health Services), Ministry of Health & Family Welfare, Govt. of India.

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 wherein the predicates are available in India.

LICENSE VALIDITY: Licenses issued in India are perpetual licenses and need to be re-validated every 5 years by paying retainership fees.

AUTHORIZED REPRESENTATIVE: The registration holder is the importer as well, as per the new medical device rules implemented with effect from Jan. 1, 2018. India allows multiple registration holders for the same products.

Last updated on January 15, 2019.

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