Health Canada Medical Device Recall Notification

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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 …

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. …

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 …

Medical Device Recall Reporting Form - Initial

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/prob-report-rapport/frm_0360_medical_device_initial_recall_reporting-eng.pdf

Health Canada Contacts for Reporting Medical Devices Recalls Notification of recall is submitted to the appropriate Region. Companies that do not know under which Region …

Medical devices - Canada.ca

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

Medical devices contained in electronic health record (EHR) products: Notice to industry [2022-10-31] Monkeypox tests: Notice to industry [2022-10-19] Subscribe to …

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

Recall (for medical devices) - In respect of a medical device that has been sold, any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or …

Help on forms - Canada

https://health.canada.ca/en/health-canada/services/consumer-product-safety/advisories-warnings-recalls/report-incident-involving-consumer-product-b/help-forms.html

Section 9 in the Cosmetic Notification Form Use the "Choose File/Browse" button to select the .hcxs file you saved on your computer before. Once you have it open, you may …

Foreign risk notification for medical devices guidance …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/responsibilities.html

A foreign regulatory agency or a manufacturer issues a communication informing the public that patients with certain characteristics shouldn’t use a medical device as there may be a …

Health Canada Guidance on Recalls: …

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

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 intended to …

Update: list of medical devices for mandatory shortage …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/notice-update-list-devices-reporting-shortages-covid-19-2022-02-01.html

Updates to list of medical devices for mandatory shortage reporting: Notice This notice is to inform licence holders that the List of Medical Devices – Notification of …

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