As a medical device manufacturer, I need to understand the post-market obligations for medical devices in Australia. Navigate to the relevant section and identify the key activities required for post-market monitoring and the timeframe within which adverse event reports must be submitted to the TGA.
Navigate to 'tga.gov.au' Click on 'Products we regulate' Click on 'Medical devices' Click on 'Post-market monitoring of medical devices' Identify the key activities required for post-market monitoring. Identify the timeframe for submitting adverse event reports.
Successfully navigate to the 'Post-market monitoring of medical devices' page. State the key activities required for post-market monitoring (e.g., vigilance, trend reporting, post-market clinical follow-up). State the specific timeframe for submitting adverse event reports (e.g., within 10 calendar days for serious incidents, 60 calendar days for non-serious incidents).