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India UDI Framework Overview

Background​

India introduced a Unique Device Identification (UDI) framework through amendments to the Medical Devices Rules 2017, aligned with the IMDRF UDI guidance. The framework requires medical devices to carry a unique identifier that enables unambiguous identification throughout the supply chain.

Two components​

ComponentDescription
UDI-DI (Device Identifier)Identifies the specific version/model; tied to the device label
UDI-PI (Production Identifier)Identifies production-specific information (lot, serial, expiry)

UDID — India's national database​

The Unique Device Identification Database (UDID) at udid.cdsco.gov.in is the national registry for Indian UDI records. Manufacturers submit device information to UDID as part of the licensing process.

Implementation timeline​

UDI implementation follows a phased approach with higher-risk devices (Class C and D) subject to earlier compliance dates than lower-risk devices (Class A and B). All devices must eventually be enrolled in the UDID database; new device applications submitted after a specified effective date may face stricter UDI requirements. Check UDI Implementation Timeline for the current schedule.

Official source: Medical Devices Rules 2017 (as amended); CDSCO UDI