UDI in India
India's UDI framework aligns with IMDRF UDI guidance. CDSCO accepts UDI barcodes from internationally accredited issuing agencies (GS1, HIBCC, ICCBBA). Devices must be enrolled in the UDID national database.
Official source: UDID — CDSCO; Medical Devices Rules 2017 (as amended)
Add the following section:
UDID Database Overview
The Unique Device Identification Database (UDID) at udid.cdsco.gov.in is India's national registry for UDI records. All manufacturers holding a valid device license must enroll their devices in UDID.
Data Submitted to UDID
Manufacturers provide:
- UDI-DI and UDI-PI values
- Device name, brand, and model information
- Device classification (Class A, B, C, or D)
- Manufacturing and packaging details
- Issuing agency details
Registration Process
During the device licensing application process, manufacturers submit device information directly through the CDSCO portal. Updates to device information must be reported to CDSCO within 30 days of any changes.