Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-13C.1: UDI identifiers: obtain the UDI device identifier and packaging identifiers from a single UDI issuing agency and allocate production identifiers under that agency's rules

What does sch1-13C.1 require?

For each type of model of UDI medical device, the UDI device identifier must have been issued by a UDI issuing agency (for example GS1, HIBCC or ICCBBA), the production identifier must be allocated by or for the manufacturer under any rules of the agency that issued the device identifier, any packaging identifier must also come from an issuing agency, and the device and packaging identifiers must come from the same agency.