Manufacturers and importers must report incidents in Canada involving a device sold there that relate to failure, deterioration in effectiveness or inadequate labelling or directions and that led, or on recurrence could lead, to death or serious deterioration in health (CMDR 59(1); incidents outside Canada remain reportable only for Class I). The preliminary report is due within 10 days of awareness where death or serious deterioration occurred and within 30 days where recurrence might cause it (CMDR 60(1)), with the content listed in CMDR 60(2) (device identifiers, manufacturer and importer details and contact, dates, details and consequences, reporter, other devices involved, preliminary comments, proposed actions and timetable, previous reports). A final report must follow on that timetable with a description, number of people affected, a detailed cause explanation and actions taken (CMDR 61). If only the importer reports, the manufacturer must confirm in writing (form FRM-0090) that the reports would be identical (CMDR 61.1). Manufacturers must also tell the Minister within 72 hours about serious risks of injury communicated by listed foreign regulators, related labelling changes, and foreign recalls, reassessments or suspensions (CMDR 61.2, 61.3).
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.