Canada Medical Devise Recall

Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html

report medical device recalls to Health Canada write procedures for distribution record keeping and recall If Health Canada believes you are selling a medical device that may seriously or imminently harm someone's health, we may order you to: …

Recalls - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls.html

Recalls - Canada.ca Recalls The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. …

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

Medical Device Respirator recalls - Canada.ca

https://recalls-rappels.canada.ca/en/alert-recall/medical-device-respirator-recalls

In Canada, re-labelling of a medical device that fails to conform to claims relating to its effectiveness is considered a recall in accordance with the Medical Devices …

Medical Device Respirator recalls - Recalls and safety …

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73137a-eng.php?from=groupmessage&isappinstalled=0

In Canada, re-labelling of a medical device that fails to conform to claims relating to its effectiveness is considered a recall in accordance with the Medical …

Medical devices - Canada.ca

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

Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical …

Advisories, Warnings and Recalls – Drugs and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/advisories-warnings-recalls.html

Health Canada believes that staying informed can help you stay healthy. To this end, the Department posts safety alerts, public health advisories, press releases and other notices …

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

As is defined in section 1 of the Regulations, in respect of a medical device that has been sold, recall means any action taken by the manufacturer, importer or distributor of the device to recall or …

Recent Changes to Medical Device Regulations in Canada

https://www.regdesk.co/summary-recent-changes-to-medical-device-regulations-in-canada/

Recalls, including product withdrawals; Reassessment; and Suspension or revocation of an authorization This requirement only applies when actions listed above are taken in certain foreign countries regarding …

Problem Reporting - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting.html

Recall Reporting for Medical Devices: Medical device initial recall reporting form (FRM-0360) Medical device final recall reporting form (FRM-0360) Guide to Recalls of …