Health Canada Medical Device Recall Guidance

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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

Health Canada's Recall Policy further specifies that you must provide verbal or written notification to Health Canada within 24 hours of deciding to proceed with a recall. If you are not able to notify us within this time frame, you must provide a rationale …

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 …

Compliance and enforcement of medical devices

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

Guidance Medical devices recall guide (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) Guidance on Risk …

Recalls - Canada.ca

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

The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes …

Recall policy for health products - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/recall-policy-0016/policy.html

Guidance documents – Medical devices - Canada.ca

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

Guidance documents – Medical devices. For industry information about COVID-19, visit our COVID-19 medical devices section. Guidance documents have …

Medical devices - Canada.ca

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

As announced by the Honourable Ginette Petitpas Taylor, Minister of Health, Health Canada has developed an Action Plan to accelerate its efforts to strengthen the …

Drug and natural health products recall guide - Canada.ca

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

It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that …

Health Canada Guidance on Recalls: Basics | RegDesk

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 …

Health Canada Guidance on Recalls: Notification and …

https://www.regdesk.co/health-canada-guidance-on-recalls-notification-and-corrections/

During the first two stages of a recall process, the party responsible for a medical device (e.g., medical device manufacturer) identifies the need in recall and …

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