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UDI Labelling Requirements

What must appear on the label?​

Under SFDA MDS-REQ 7, device labels must carry:

  • Device Identifier (DI) in human-readable format
  • Production Identifier (PI) — lot/batch number, serial number, and/or expiry date — in human-readable format
  • Machine-readable format — barcode (e.g. GS1-128, Data Matrix) or RFID for most device classes; the specific format requirements depend on class and device type

Issuing agencies​

Manufacturers may obtain their UDI device identifiers from internationally recognised issuing agencies, including:

  • GS1 (most common globally)
  • HIBCC (Health Industry Business Communications Council)
  • ICCBBA (for blood, cell, and tissue products)

The SFDA accepts DIs issued by these internationally recognised agencies.

UDI on packaging levels​

UDI requirements typically extend to multiple packaging levels:

  • Unit of use — the individual device
  • Intermediate packaging — e.g. boxes of 10
  • Shipping container — carton or pallet level

Different DIs may be assigned to different packaging configurations of the same device model.

Further reading​