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唯一器材識別(UDI)
透過分銷和使用充分識別醫療器材的系統。UDI由器材識別符（UDI-DI）和生產識別符（UDI-PI）組成。FDA、EU MDR和其他監管機構要求。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
UDI systems identify devices through distribution and use. FDA UDI, EU MDR UDI, and other jurisdictions require device identifiers on labels and often database registration (GUDID, EUDAMED).
PROCESS / STEPS
- Assign UDI-DI (device model) via an FDA-accredited issuing agency (or EU-equivalent).
- Define UDI-PI production identifiers (lot, serial, expiry, manufacture date) as applicable.
- Place AIDC (barcode/RFID) and HRI (human readable) on labels/packaging per rule.
- Submit device identifier data to GUDID (US) and relevant EU modules when required.
- Maintain change control when packaging or device versions create new DIs.
EXAMPLES
- A sterile implant package carries UDI on the label and unit-of-use packaging hierarchy.
RELATED GUIDES & TOOLS
SOURCES
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