No ARTG device application may contain information that is untrue or misleading in a material respect. The applicant must certify that the devices are medical devices; are intended for a specified purpose ascertained from labelling, instructions, advertising and technical documentation; are correctly classified; comply with the essential principles, and that it either holds enough information to substantiate that or has procedures, including a written agreement with the manufacturer containing the prescribed matters, to obtain it within the prescribed period; that appropriate conformity assessment procedures, or comparable overseas requirements, have been applied and it can substantiate that in the same way; that the Advertising Code and other advertising requirements are complied with; that imports, exports, manufacture and supply will not breach any section 9K prohibition or its conditions; that the devices contain no prohibited import substances and are not for an excluded purpose; and that the application is complete and correct. Except for Class I devices, the applicant must state whether the conformity certification rests on a TGA conformity assessment certificate, an Australian conformity assessment body certificate or an overseas regulator conformity assessment document in force. Knowingly false statements are offences tiered by harm, with strict liability and civil penalty versions.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.