WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Placing on the market: establishment registration, authorized representatives, importers and distributors, listing, import documents, UDI and distribution – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.3.1.5-UDI: Where the NRA adopts UDI, assign UDI-DIs and UDI-PIs through an accredited issuing agency, apply them to labels and packaging in human- and machine-readable form, and submit UDI-DI data with a nomenclature term to the UDI database

What does 6.3.1.5-UDI require?

Under a UDI system the manufacturer assigns each device, at production, a UDI made up of a device identifier specific to the model and a production identifier (serial number, lot or batch, software version, manufacturing or expiry date), using the specifications of a government-recognised issuing agency such as GS1, HIBCC, ICCBBA or IFA. The UDI must appear on the device label and its packaging, and the device identifier with specified data, including an assigned nomenclature term, must be submitted to the public UDI database. Applying UDI should be a condition for placing a device on the market where the system exists.

Maintained by Gerard Blokdyk

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