Health Canada Medical Device Recall Regulations

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 …

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

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 …

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. …

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

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

Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - …

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

Summary: 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.html

This policy is for people who work with: drugs as: sellers, distributors, manufacturers, importers, packagers, labelers and wholesalers medical devices as: sellers, distributors, …

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, …

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

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-1.html

recall, in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to …

Frequently Asked Questions - Medical Devices Regulations

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html

Certain sections of the Medical Devices Regulations came into force in July, September and November of 1998. All sections were in force on January 1, 2003. Where can I get …

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. …