Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-13C.5: UDI direct marking: from the direct marking start day, directly mark reusable devices that are reprocessed between patients with the device and production identifiers, in both forms where practicable, unless implantable, made earlier, or marking would harm performance or is impracticable

What does sch1-13C.5 require?

For a type of model intended to be reprocessed between uses on different patients, the manufacturer must directly mark the UDI device identifier and production identifier on the device itself, in human-readable and machine-readable form, or in one form where both are impracticable or inappropriate. The duty does not apply to devices made before the direct marking start day, to implantable devices, where direct marking is likely to affect safety, performance or effectiveness, or where it would be impracticable; the manufacturer should document which ground applies.