Australia: the organisation must decide whether UDI applies and, where it does, pick an issuing agency the TGA recognises and use its system to allocate identifiers to its coding standard (UDI-DI, UDI-PI, unit of use DI, direct marking DI and package DIs); plan production to apply UDI carriers in human-readable and machine-readable form on the base package label, on the device itself where it must be direct-marked and on higher packaging levels (human-readable only for software shown on screen); allocate a new UDI-DI through change control where changes could cause misidentification; and keep evidence that UDI labelling supports the labelling Essential Principles. The TGA is phasing UDI in over five years, high-risk devices first, with responsibilities shared with the sponsor. United States: determine UDI applicability under 21 CFR 801 and 830, obtain UDIs from an FDA-accredited issuing agency, show them in plain text and AIDC form in the required locations, and load the required data into the FDA's Global Unique Device Identification Database (GUDID) (labelers, including contract manufacturers, private label distributors and kit assemblers, carry these duties).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.