When a Recall is Required
Circumstances that trigger a recall or other market action under Australia's PRAC framework, and the sponsor's obligations when a safety issue arises.
Recall Classifications & Levels
How recalls are classified under Australia's PRAC framework, what each class means for the urgency and scope of action required.
Field Safety Corrective Actions
What field safety corrective actions (FSCAs) are, how they differ from recalls, and how to manage them under Australia's PRAC framework.
TGA-Initiated Actions
When the TGA initiates a recall or other market action for a medical device without the sponsor's initiation, and what happens when the TGA takes direct regulatory action.