A sponsor that knows of information of the kinds listed and fails to give it to the Secretary within the period in the regulations commits an offence (12 months or 1,000 penalty units), whether or not it has already given other information on the same matter. The civil penalty provision (section 41MPA, up to 3,000 penalty units for individuals and 30,000 for bodies corporate) covers: malfunction or deterioration in characteristics or performance; inadequacy in design, production, labelling, instructions or advertising; use within or contrary to the intended use, where any of these might lead or might have led to death or serious deterioration of a patient or user; technical or medical reasons for a malfunction that led the manufacturer to recall distributed devices; information indicating that devices do not comply with the essential principles; and information that a certificate or other document used in the ARTG application to show essential principle compliance or conformity assessment has been restricted, suspended, revoked or is no longer in effect. The court may relieve a person with a reasonable excuse who ought fairly to be excused (section 41MPB). The periods are in regulation 5.7 of the Medical Devices Regulations.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.