Health Canada Medical Device Guidance

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Guidance documents – Medical devices - Canada.ca

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

Fees for Medical Devices. For fee-related guidance documents and forms, please visit Fees for Medical Devices. Notice: Guidance Document Updates to Reflect New Fees and Policies for April 1, 2020; Medical Devices Guidance Documents. Health …

Guidance Document: Guidance for the Labelling of …

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

Document Change Log Change Location (section, paragraph) Nature of and/or Reason for Change : Full Document: Rewritten to add clarity, conform to Good …

Guidance on summary reports and issue-related …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html

Incident reporting for medical devices: Guidance …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-310-2021-eng.pdf

Regulations enable Health Canada's participation in international alert systems. Health Canada, along with its international partners in the Global Harmonization Task Force …

Guidance Document - Medical Device Licence Renewal …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html

In the event that Health Canada's Medical Devices Licence Listing database is not updated within 20 days following receipt of a complete Annual Notification Package, …

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

The manufacturer and importer of a medical device shall, as soon as possible after the completion of a recall, each report to Health Canada: the results of the recall. …

Health Canada Issues Final Guidance on Clinical …

https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices

Health Canada has finalized the Guidance on Clinical Evidence Requirements for Medical Devices.This guidance outlines the general principles and criteria for clinical evidence that may be …

Filing submissions electronically - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html

Guidance documents, notices and supporting documents All electronic formats. Regulatory Enrolment Process (REP) REP is a common submission intake method across product …

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