Health Canada Medical Device Adverse Event Reporting

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Incident reporting for medical devices: Guidance document

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

One of the study groups within the GHTF has produced a document entitled " Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices" (N54) …

Mandatory Medical Device Problem Reporting Form for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-medical-device-problem-reporting-form-industry-adverse-reaction-reporting.html

This section contains information about the reporter, who is submitting the report to Canada Vigilance - Medical Devices Problem Reporting Program (CV-MD) to fulfil their …

Adverse Reaction Database - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html

The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products. Adverse …

Report a side effect of a health product, drug or medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html

All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only …

Mandatory reporting of serious adverse drug reactions …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices/guidance.html

5.4 Reporting criteria for medical device incidents 5.4.1 An incident has occurred 5.4.2 Considerations in assessing reportability 5.5 The incident led to one of the following outcomes 5.5.1 Death of a …

Adverse reactions, medical device incidents and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html

420,120 adverse reactions were mentioned in the reports sent to Health Canada the top 4 reported adverse reactions included: general disorders and administration site …

Mandatory Adverse Reaction Reporting Form for Industry

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-adverse-reaction-reporting-form-industry.html

For Drugs and Natural Health Products, a serious adverse reaction is a noxious and unintended response to a drug or natural health product that occurs at any dose and that …

Adverse Reaction Reporting Information - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/adverse-reaction-reporting-adverse-reaction-reporting-information.html

Anyone -- including consumers, patients, caregivers, physicians, pharmacists, nurses, and dentists can report an adverse reaction to drugs or health products on the …

Medical Device Incidents - Drug and Health Product Register

https://hpr-rps.hres.ca/mdi_landing.php

Medical Device Incidents Home Medical Devices Drugs Natural Health Products Medical Devices Review Decisions Submit a report Prescription Drug List About Search Medical …