Health Canada Medical Device Vigilance

Canada Vigilance Program - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html

The Canada Vigilance Program is supported by seven Canada Vigilance Regional Offices who provide a regional point-of-contact for health professionals and consumers. Reports are collected by the regional offices before being forwarded to the Canada Vigilance …

Incident reporting for medical devices: Guidance …

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

Health Canada, along with its international partners in the Global Harmonization Task Force (GHTF), has developed agreements and documents to promote a …

Guidance Document: Pre-market Requirements for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity/document.html

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis …

Notice for Industry: Mandatory Reporting Requirement …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-industry-mandatory-reporting-requirement-covid-19-pandemic.html

In light of the COVID-19 outbreak, Health Canada is clarifying expectations for manufacturers, importers and market authorization holders (MAHs) regarding …

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

Completed forms should be emailed to: [email protected] or faxed to: 1-866-678-6789 or mailed to: Canada Vigilance - Medical Device Problem Reporting Program. …

Drug and Medical Device Databases - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-and-medical-device-databases.html

The Canada Vigilance Adverse Reaction online database contains information on suspected adverse reactions to health products for sale in Canada that …

Medical Device Incidents - Drug and Health Product Register

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

Search Medical Device Incidents. Search for term (s) Download Full Extract. Disclaimer. Date modified: 2021-07-14.

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of …