An application to the TGA for a conformity assessment certificate must be made in the approved form or manner, delivered to the specified office and accompanied by the prescribed fee; an unpaid fee, or any materially untrue or misleading content, leaves the application without effect. The Secretary may by written notice require the applicant to allow an authorised person to inspect at a reasonable time the premises, including those outside Australia, and the equipment, processes and facilities used or to be used to manufacture the devices, and other devices on those premises. Knowingly giving untrue or misleading material in, or connected with, the application is an offence (up to 5 years or 4,000 penalty units where device use is likely to cause harm, otherwise 12 months or 1,000 penalty units), with a 100 penalty unit strict liability offence and a civil penalty (section 41EIA).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.