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Reporting Device Adverse Events in Canada

Timelines for Reporting:

10 Calendar Days:

Section 60(1)(a) of the Regulations requires that if the death or serious deterioration in health of the patient, user or other person has occurred, a report must be submitted to Health Canada within 10 calendar days.

When serious deterioration in health is the result of an incident, a report to Health Canada must be submitted within 10 calendar days, in accordance with section 60(1)(a)(i) of the Regulations

30 Calendar Days:

If death or serious deterioration in health did not occur as a result of the incident, but might if the incident were to recur, then the report must be submitted to Health Canada within 30 calendar days.

HOW TO REPORT

Completed forms should be emailed to hc.mdpr-dimm.sc@canada.ca or faxed to 613-954-0941 or mailed to:

Canada Vigilance - Medical Device Problem Reporting Program

Marketed Health Products Directorate

Health Canada

Address Locator 1908C

200 Tunney's Pasture Driveway

Ottawa (Ontario) K1A 0K9

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Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices): SOR/2020-262

Guidance on summary reports and issue-related analyses for medical devices: Overview

Effective Date: June 23, 2021

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Guidance on releasing information from adverse reaction and medical device incident reports to the public

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