Importer & Manufacturer | Source: CDSCO
Published On: 20-11-2025
Enforcement Date: 17 November, 2025
Requirement of License issued by CDSCO/State Licensing Authorities in procurement of Medical Devices by procurement agencies
The Central Drugs Standard Control Organization (CDSCO) has issued a circular stating that procurement agencies, including hospitals, must mandatorily require CDSCO/State Licensing Authority (SLA) licenses when procuring medical devices. Only licensed devices may be imported, manufactured, sold, or distributed under the Medical Devices Rules, 2017. Certifications like USFDA or CE may be optional but cannot replace CDSCO/SLA licensing.
The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, issued a circular clarifying licensing requirements for the procurement of medical devices in India.
Key points include:
- It has been observed that many procurement agencies and hospitals insist on USFDA/CE certifications during technical bid evaluation.
- CDSCO emphasises that under the Medical Devices Rules, 2017, framed under the Drugs and Cosmetics Act, 1940, all medical devices must have a valid CDSCO/SLA license for import, manufacturing, sale, or distribution in India.
- Devices are classified based on risk into Class A, B, C, and D.
- State/UT Licensing Authorities handle licensing for Class A & B manufacturing and sale of all classes.
- At the same time, CDSCO issues import licenses and Class C & D manufacturing licenses after technical review and QMS assessment.
- Procurement agencies must mandate CDSCO/SLA licensing and may consider other global certifications only as additional criteria.
Applicable For: Importer & Manufacturer
Reference Number: File no. MED-13/87/2025-eoffice
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