A custom-made device made in Australia is exempt from inclusion only if its manufacturer always has available enough information to show the conformity assessment procedures were applied, or information on the design, manufacture and changes; lets an authorised person enter any premises where the device is dealt with (including overseas), inspect, test, sample and record; produces device documents for copying when asked; and gives the Secretary a copy of the health professional's request within the period requested (at least 10 working days). For a custom-made device made overseas, the sponsor must have procedures that ensure the overseas manufacturer does the same, and must itself supply the health professional's request on request.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.