INOPP Forum
Device Vigilance Requirements in Australia
Adverse event
An adverse event is an occurrence involving a medical device that meets the following criteria:
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death of a patient, health care provider, user or other person; or
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a serious injury or serious deterioration to a patient, health care provider, user or other person, including;
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a life-threatening illness or injury;
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permanent impairment of a body function;
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permanent damage to a body structure; or
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a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Near adverse event
A 'near adverse event' is an occurrence involving a medical device that might have led to a death or serious injury if, for example, the timely intervention of a healthcare practitioner is the only reason a death or serious injury did not occur. For an event to be defined as a near adverse event, it is sufficient that:
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an event associated with the device occurred; and
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if the event occurred again, it might lead to death or serious injury as outlined above.
REPORTING REQUIREMENTS
Follow-up report
The TGA acknowledges that the manufacturer's investigation of some events will take time. You are expected to provide the TGA with information regarding the status of any internal manufacturing investigation at regular intervals and no less than every thirty (30) calendar days.
Final report
Within ninety (90) calendar days of the submission of an initial report the TGA expects that the manufacturer has had sufficient time to undertake a detailed investigation of the reported adverse event. Your final report should ensure that all requisite information as outlined under “What do I need to report?” has been provided to the TGA. We will push back reports that do not contain the information required to meet these obligations. Sponsors should pay particular attention to the provision of any similar event information, corrective and preventative actions (CAPA), and manufacturer's device analysis.
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Adverse event
An adverse event is an occurrence involving a medical device that meets the following criteria:
death of a patient, health care provider, user or other person; or
a serious injury or serious deterioration to a patient, health care provider, user or other person, including;
a life-threatening illness or injury;
permanent impairment of a body function;
permanent damage to a body structure; or
a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Near adverse event
A 'near adverse event' is an occurrence involving a medical device that might have led to a death or serious injury if, for example, the timely intervention of a healthcare practitioner is the only reason a death or serious injury did not occur. For an event to be defined as a near adverse event, it is sufficient that:
an event associated with the device occurred; and
if the event occurred again, it might lead to death or serious injury as outlined above.