Australia Therapeutic Goods (Medical Devices) Regulations 2002 r5.7: Automatic condition: report adverse events to the Secretary within 48 hours for a serious public health threat, 10 days for a death or serious deterioration, 30 days where recurrence might cause one, and otherwise within 60 days

What does r5.7 require?

The ARTG entry holder (the sponsor) must give the Secretary the adverse event information described in sections 41MP(2) and 41MPA(2) of the Act within: 48 hours of becoming aware where the event represents a serious threat to public health (a hazard from a systematic failure, not previously known or anticipated, that may cause death or serious injury and needs prompt action to remove or reduce the risk); 10 days where it led to the death or serious deterioration in health of a patient, user or other person; 30 days where a recurrence might do so; and 60 days in any other case. Serious deterioration means a life-threatening illness or injury, permanent impairment of a body function, permanent damage to a body structure, or a condition needing medical or surgical intervention to prevent those. The same periods apply to the offence and civil penalty provisions (regulations 10.4 and 10.4AA).