On or before undertaking a recall, manufacturers and importers must give the Minister the information in CMDR 64 (device name and identifiers, manufacturer, importer and manufacturing site, reason, nature and discovery of the defect, risk evaluation, units made, imported and sold in Canada, distribution period, consignees and quantities, recall communications, recall strategy and timetable, prevention action and a contact). Health Canada interprets this as submitting what is known within 24 hours of the decision to recall (verbally or in writing), then a complete written report no later than three business days after the recall begins. After completion, the results and actions to prevent recurrence must be reported as soon as possible (CMDR 65). Where only the importer reports, the manufacturer must confirm in writing that the reports would be identical (CMDR 65.1).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.