The Minister may exempt specified medical devices from the Register requirements to deal with an actual or potential threat to public health caused by an emergency. Each exemption carries conditions on quantity, source, who may import, manufacture, supply or export, supply including stockpile release, storage and security, UDI requirements, keeping, disclosure of and access to records, disposal and how devices are dealt with after a breach. Breaching a condition is an offence and civil penalty (Division 3A of Part 4-11), and misrepresenting that devices are covered by an emergency exemption is a civil penalty (section 41MND). When the exemption ends, unused devices must be disposed of under the arrangements in Schedule 3A of the Medical Devices Regulations.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.