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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Mandatory CDSCO/SLA Licensing for Medical Device Procurement

17-Nov-2025 | Circular No. MED-13/87/2025

This circular is regarding the procurement of medical devices by hospitals and other agencies. Some hospitals and agencies were asking for USFDA or CE certification, but the circular clarified that every medical device sold or used in India must have a valid license from either CDSCO or the State/UT Licensing Authority (SLA). Devices are divided into four risk categories: Class A (low), Class B (low to moderate), Class C (moderate to high), and Class D (high). SLA issues licenses for Class A and B manufacturing and all sales, while CDSCO issues import licenses and manufacturing licenses for Class C and D. The circular makes it clear that CDSCO (Central Drugs Standard Control Organization) or SLA license is mandatory for procurement, and other certifications like USFDA or CE are optional. This ensures that all medical devices in India meet quality and safety standards.

All procurement agencies, including hospitals and health institutions, are required to verify that any medical device being procured has a valid license from CDSCO or the respective State/UT Licensing Authority. Other certifications, such as USFDA or CE, may be considered additional but cannot replace Indian licensing. Devices without such licensing cannot be legally sold or procured in India.

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