UDI India Framework and UDID National Database
CDSCO is rolling out India's Unique Device Identification (UDI) framework, aligned with the IMDRF UDI guidance. Under the framework, manufacturers are required to:
- Assign a UDI-DI (Device Identifier) and UDI-PI (Production Identifier) to each device and its packaging.
- Label devices with the UDI in human-readable and machine-readable format.
- Submit device information to the UDID (Unique Device Identification Database) maintained by CDSCO through the SUGAM portal.
🔖 Status: phased implementation; higher-risk device classes first
Manufacturers supplying devices in India should monitor CDSCO announcements for the applicable UDI implementation timeline for their device class. Early engagement with your IAR to coordinate SUGAM account setup and UDID submissions is recommended, as the portal requires Indian business credentials.
View official source (CDSCO — UDI) ↗