UDI-K Overview and Structure
The Korean Unique Device Identification (UDI-K) system requires medical devices to carry a unique identifier enabling supply-chain traceability and facilitating post-market surveillance.
UDI-K structure
| Component | Description |
|---|---|
| Device Identifier (DI) | Static — identifies the specific version or model. Same for all units of a given model. |
| Production Identifier (PI) | Dynamic — identifies the specific production unit: lot/batch, serial, expiry date, manufacturing date. |
The complete UDI-K is expressed as a barcode or data matrix on the device label.
Phased implementation
| Phase | Grade | Implementation date |
|---|---|---|
| Phase 1 | Grade IV | January 2022 |
| Phase 2 | Grade III | January 2024 |
| Phase 3 | Grade II | TBD (expected 2025–2026) |
| Phase 4 | Grade I | TBD |
note
Confirm current dates with MFDS — the schedule may be updated.
Global alignment
UDI-K is aligned with the IMDRF UDI guidance and is compatible with GS1 GTIN-based UDI systems used globally (FDA GUDID, EUDAMED UDI). Manufacturers already using GS1 GTINs for other markets can reuse them for UDI-K.