The health of Canadians could be at risk because Health Canada doesn’t know if it is doing enough surveillance and inspections to ensure medical devices are safe and effective, the office of the auditor general says. The audit found that overall the department’s progress on regulating medical devices was “unsatisfactory” because it has failed to adequately address concerns raised in two previous audits dating back to 2004. Under the Food and Drugs Act, Health Canada regulates the safety and effectiveness of all medical devices marketed in Canada. But according to the audit, completed last October, the department doesn’t know what level of inspection activities and surveillance are needed to protect the health and safety of Canadians.
