The Secretary may by written notice require an applicant for or holder of a conformity assessment or Australian conformity assessment body certificate, an ARTG applicant, or a current or former sponsor, to give information or documents about whether the devices meet the essential principles, whether conformity assessment or comparable requirements were applied, compliance with certificate or inclusion conditions, compliance with the Advertising Code and other advertising rules, whether the devices are being supplied, imported or exported, compliance with section 9K prohibitions, safety and efficacy for their purpose, regulatory history in other countries and prescribed matters (regulation 8.1A). The person must respond within the reasonable period stated, not less than 10 working days, and in the specified form. Failing to comply without reasonable excuse is an offence (500 penalty units, or 100 penalty units strict liability) and can lead to suspension or cancellation; giving false or misleading information is an offence tiered by harm and a civil penalty (section 41JBA). Part 4-8 Division 2 lets the Secretary obtain information about devices covered by exemptions, approvals and authorities in a similar way (sections 41JCA to 41JJ).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.