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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:

Implementation Timeline by Device Class​

Device ClassCompliance DeadlineNotes
Class D (Highest Risk)[Insert actual date from CDSCO]Includes implantable devices, cardiac devices, etc.
Class C (High Risk)[Insert actual date from CDSCO]Includes devices with significant patient risk
Class B (Medium Risk)[Insert actual date from CDSCO]Includes diagnostic and monitoring devices
Class A (Lowest Risk)[Insert actual date from CDSCO]Includes low-risk devices

Note: For the most current implementation dates, refer to the latest CDSCO notifications and amendments to the Medical Devices Rules 2017.