Steps for Report Submission

The doc additionally describes particular steps to be adopted when submitting a report. In response to the steerage, the preliminary report, as per Part 64, have to be submitted inside three enterprise days following the beginning of the recall, using the Medical System Recall Reporting Kind – Preliminary (FRM-0360).

The ultimate report, compliant with Part 65, needs to be submitted promptly after the recall’s conclusion, utilizing the identical kind. If this timeline just isn’t met, quick notification to Well being Canada will probably be submitted inside 24 hours of a recall determination, with an evidence included within the preliminary report.