Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-13.5-13.6: UDI on the device: from the device's general start day provide the UDI device identifier and production identifier in human- and machine-readable form on the device, else its packaging (or outer packaging), else a leaflet or electronically for software, and put the packaging identifier on each packaging level

What does sch1-13.5-13.6 require?

For a UDI medical device (a Register-covered device in Class III, IIb, IIa or sterile Class I, or an IVD in Class 2 to 4 or a Class 1 IVD with GMDN codes CT944 or CT943, but not in-house IVDs), the UDI device identifier and production identifier must be supplied in human-readable and machine-readable form on the device itself, or if that is impracticable on its packaging (outer packaging where devices are packed together), or failing both on a supplied leaflet or, for software, electronically. Devices due for direct marking under clause 13C.5 must carry the identifiers on the packaging or leaflet once their direct marking start day arrives. Devices intended for retail supply need not carry the production identifier in machine-readable form. Each packaging level must carry its own medical device packaging identifier in both forms. These duties apply to supplies, first imports and exports on or after the device's general start day, which the dictionary stages from 1 July 2026 (Class III and IIb without an EU certificate on 30 June 2026) through 2027 to 2029 and to 1 January 2030 for some IVDs.