Canadian Medical Device Recalls

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Recalls - Canada.ca

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

Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11] Product Recall Procedures Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)

Advisories, Warnings and Recalls – Drugs and health …

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

The Canadian Adverse Reaction Newsletter (CARN), a quarterly publication providing information about adverse reactions and safety alerts to health care professionals,; …

Find recalls, advisories and safety alerts - Canada.ca

https://recalls-rappels.canada.ca/en

Latest recalls and safety alerts. Health Canada warns that Dr. Crafty branded epoxy kits may pose an injury hazard due to improper labelling. Alert Consumer product advisory | …

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 …

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

Canadian regulations often define "recall" more broadly than other countries. If you manufacture medical devices outside Canada, be aware that some actions …

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 …

Medical Device Respirator recalls - Canada.ca

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

Dongguan Oukangda Medical Technology Co., Ltd. Kangerda KN95 Particulate Respirator. Innoline Inc. 2020-05-13. Dongguan Tian Ren He Yi intelligent Co., LTD. KN95 Mask. …

Incident reporting for medical devices: …

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

Under this provision, incident reports for foreign incidents are no longer required for Class II-IV devices. Class II-IV devices must adhere to section 61.2 a notification provision of a …

Recent Changes to Medical Device …

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

Jul 15, 2021. In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device …

Health Canada Guidance on Recalls: …

https://www.regdesk.co/health-canada-guidance-on-recalls-basics/

Jul 22, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The document is …

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