Australia Therapeutic Goods Act 1989 s41FN-3: Automatic ARTG conditions: always hold, or be able to obtain from the manufacturer within 20 working days, the essential principle evidence, conformity assessment evidence and information on changes to the device, product range or quality system; give it to the Secretary on request; report adverse events within the prescribed periods; and pass relevant information back to the manufacturer

What does s41FN-3 require?

For as long as the entry stands, the sponsor must either keep on hand enough evidence to back up essential principle compliance, the conformity assessment (or comparable overseas) route applied, and any changes the manufacturer makes to the device, its range or its quality system, or have arrangements, including a written agreement, under which the manufacturer will hand that evidence over within 20 working days. It must give the information to the Secretary when asked, give adverse event information of the kinds in sections 41MP(2) and 41MPA(2) within the periods prescribed (regulation 5.7: 48 hours, 10, 30 or 60 days), and give the manufacturer information relevant to its conformity assessment obligations and to whether the devices comply with the essential principles. Regulations and ministerial determinations add further automatic conditions (Medical Devices Regulations Part 5, Division 5.2).