Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
Labelling and patients

Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 device-labelling: Provide the UDI on the device or pack

What does device-labelling require?

A UDI device must be provided with its device identifier and production identifier. The general rule is the device itself in human and machine readable form. If that is impracticable or inappropriate, the pack, then the outer pack for a multipack, then a leaflet or an electronic form for software. A device covered by the direct marking rule moves to the pack or leaflet route from its direct marking start day. A retail device may omit the production identifier in machine readable form.

Maintained by Gerard Blokdyk

Other controls in Labelling and patients

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.