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:
CDSCO-Recognized Issuing Agencies
CDSCO accepts UDI barcodes issued by the following internationally accredited organizations:
| Issuing Agency | Acronym | Type of Identifier |
|---|---|---|
| GS1 India | GS1 | GTIN (Global Trade Item Number) |
| Health Industry Business Communications Council | HIBCC | UPN (Unique Product Number) |
| International Committee for the Red Cross Blood Bank Coding | ICCBBA | ISBT 128 |
Manufacturers may obtain UDI codes from any of these accredited agencies. Registration with CDSCO is required before commercial distribution in India.