INOPP Forum
Reporting Device Adverse Events in Canada
Quote from VigiServe Admin on November 27, 2020, 9:43 AMTimelines 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
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
Uploaded files:- You need to login to have access to uploads.
Quote from VigiServe Admin on December 30, 2020, 9:40 AMRegulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices): SOR/2020-262
Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices): SOR/2020-262
Quote from VigiServe Admin on January 28, 2021, 12:27 PMGuidance on summary reports and issue-related analyses for medical devices: Overview
Effective Date: June 23, 2021
Guidance on summary reports and issue-related analyses for medical devices: Overview
Effective Date: June 23, 2021
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Quote from VigiServe Admin on September 7, 2022, 3:52 AMGuidance on releasing information from adverse reaction and medical device incident reports to the public
Guidance on releasing information from adverse reaction and medical device incident reports to the public
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