Who determines if an incident involving a surgical implant should be reported?

To determine whether an incident is reportable, Health Canada states it must meet the following three criteria: First, a malfunction or failure of an implant occurs in real world use or through information from device testing performed by the manufacturer, user or other party. Second, a reasonable assessment determines the device likely caused or contributed to the incident. Third, the incident leads to the actual or potential death or serious deterioration in health of a patient, user or other person.