The Central Drugs Standard Control Organization (CDSCO) has issued a Circular dated November 17, 2025, to all procurement agencies, including hospitals and health institutions, mandating that a valid license issued by CDSCO or the State Licensing Authority (SLA) must be a compulsory requirement for the procurement of Medical Devices in India.
This directive addresses the issue that some procurement agencies were incorrectly insisting on certifications like USFDA or CE certification as a mandatory part of the technical bid for medical device procurement.
Regulatory Framework and Licensing Requirements
The CDSCO clarifies that all Medical Devices in India are regulated under the Medical Devices Rules, 2017, which fall under the Drugs and Cosmetics Act, 1940, to ensure their quality, safety, and performance. A license is a mandatory requirement for the import, manufacturing, sale, and distribution of medical devices in the country; no medical device can be sold in India without a valid license obtained from the Licensing Authorities.
Based on risk, Medical devices are classified into four categories:
- Class A: Low risk.
- Class B: Low to moderate risk.
- Class C: Moderate to high risk.
- Class D: High risk.
Licensing Authority Breakdown
| Function | Device Risk Class | Issuing Authority |
| Sale License | All Classes (A, B, C, D) | Concerned State/UT Licensing Authorities (SLAs) |
| Manufacturing License | Class A and Class B | Concerned State/UT Licensing Authorities (SLAs) |
| Manufacturing License | Class C and Class D | Central Licensing Authority (CDSCO) |
| Import License | All Classes (A, B, C, D) | Central Licensing Authority (CDSCO) |
The CDSCO issues licenses based on a detailed technical review and conformance of the Quality Management System.
Mandate for Procurement Agencies
All procurement agencies, including Hospitals and Health Institutions, are instructed to make the CDSCO license or the license issued by the State/UTs Licensing Authority under the Medical Devices Rules, 2017, mandatory as a primary requirement for procurement.
Any other certifications, such as USFDA or CE, which a procurement agency may desire, should be considered over and above the mandatory CDSCO or SLA Licensing Authority approval under the said rules.