Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
Adverse event reporting

Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 stage-2-devices: Class IIa and IIb devices join on 1 April 2028

What does stage-2-devices require?

From 1 April 2028, the reportable device list becomes Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The Stage 1 list is replaced by the wider list on that day.

Maintained by Gerard Blokdyk

Other controls in Adverse event reporting

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