Canada to Require Acute Care Hospitals to Report Serious Device Incidents

New Canadian regulations would require certain healthcare providers to report serious medical device incidents to Health Canada.

The proposed amendment to the country’s Food & Drugs Act would require full incident reports to Health Canada from any hospital that provides acute care products.

The agency proposes a 30-day reporting timeline for serious MDIs, with the clock starting when the institution first documents the event. Health Canada says this window achieves the necessary balance between a timely response and the time respondents will need to complete a thorough report.

Read the consultation paper here: www.fdanews.com/07-05-17-Canada.pdf. — Zack Budryk