GLOSSARYCA
Incident Reporting (CA)
A manufacturer and an importer must each give the Minister a preliminary and a final report on an incident in Canada involving a device sold there. The incident must relate to a device failure or inadequate labeling, and have led to death or a serious deterioration in health, or could if it recurred.
Preliminary report deadline, from becoming aware of the incident
- 10 days
- The incident led to the death or a serious deterioration in the state of health of a patient, user, or other person.
- 30 days
- The incident did not lead to death or a serious deterioration in health, but could do so if it recurred.