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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:

UDI-DI (Device Identifier)​

The UDI-DI is a unique numeric or alphanumeric code that identifies the specific version, model, and formulation of a medical device. It remains constant throughout the device's commercial life and is tied to the device label and packaging.

UDI-PI (Production Identifier)​

The UDI-PI captures production-specific information that varies by unit, including:

  • Lot or batch number
  • Serial number
  • Expiration or use-by date
  • Version or software release number

The UDI-PI allows tracking of individual units throughout the supply chain and supports post-market surveillance activities.