If an authorised person asks, the manufacturer must give the Secretary the system documentation, design data (analyses, calculations, tests) and manufacturing data (inspection reports, test and calibration data, staff qualifications) and arrange tests specified to check the system works; it may ask for a report of any inspection or test findings. It must make a declaration of conformity stating that it is made under clause 1.8 of Schedule 3, the manufacturer's name and business address, each kind of device's unique product identifier, class and nomenclature code, the devices covered if not all, a statement of compliance with the essential principles, classification rules and full QA procedures from design to final inspection, the certificate number, the standards applied, and the signature, name, position and date of an authorised signatory. It must keep the system documentation, change records, design examination file (Class III and Class 4 IVD), device design changes, the declaration, post-production review records and every notice or certificate from the TGA or body for at least 5 years after the last device was made, and produce them on request.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.