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How do I report an ADR to Health Canada?

Reports can be faxed to 1-866-678-6789 (toll-free) or mailed to: Canada Vigilance Program, Marketed Health Products Directorate, Health Canada, Postal Locator 0701E, Ottawa, Ontario K1A 0K9. Postage paid labels are available at .health.gc.ca/medeffect or by calling 1-866-234-2345 (toll-free).

Do adverse events need to be reported?

Report if the adverse event resulted in a substantial disruption of a persons ability to conduct normal life functions, i.e., the adverse event resulted in a docHub, persistent or permanent change, impairment, damage or disruption in the patients body function/structure, physical activities and/or quality of

What is adverse event reporting form?

The form is designed to be used voluntarily by Manufacturer/Importer/Distributor of Medical Devices, Healthcare Professionals and anyone with direct/indirect knowledge of Medical Devices Adverse Event.

What are the requirements for medical device reporting in Canada?

Incident must be reported if a medical device is sold in Canada and the incident relates to a failure of the device or a deterioration in its effectiveness, inadequacy in its labeling or directions for use, and has contributed to one or more of the following outcomes: Death of a patient, user or other person.

Who is responsible for reporting adverse events?

Who is responsible for reporting serious adverse events (SAEs)? Manufacturers are under mandatory requirements to report serious adverse events related to their products to the US Food and Drug Administration (FDA). Reporting of a serious adverse event is voluntary for healthcare professionals, consumers, and patients.

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