The Central Drugs Standard Control Organization (CDSCO), on November 17, 2025, issued a circular reaffirming that procurement agencies including hospitals and health institutions must mandatorily require a valid CDSCO/State Licensing Authority (SLA) licence for procurement of medical devices in India. CDSCO emphasized that certain agencies have been incorrectly insisting on USFDA/CE certifications during tendering, despite India having its own comprehensive regulatory framework under the Medical Devices Rules, 2017.
CDSCO clarified that all medical devices are now regulated under the Medical Devices Rules, 2017, and licensing is compulsory for their import, manufacture, sale, and distribution. Devices are classified into four risk-based classes (A, B, C, D). Manufacturing licences for Class A & B devices and sale licences for all classes are issued by State/UT Licensing Authorities, while CDSCO issues import licences for all classes and manufacturing licences for Class C & D devices following detailed technical evaluation and quality management system compliance.
The circular directs all procuring agencies to mandatorily require a valid CDSCO or SLA licence as a minimum eligibility condition for procurement. Any additional certifications, if desired, may be sought only in addition to—not in place of—the statutory licensing requirement under the Medical Devices Rules, 2017.
