Medical Device Guidance Canada

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 been prepared to assist in the interpretation of policies and governing statutes and regulations. …

Legislation and Guidelines - Medical devices - Canada.ca

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

Acts and Regulations The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food …

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

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/summary.html

This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new …

Guidance Document: Software as a Medical …

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

Software as a Medical Device (SaMD) 1 The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical …

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

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

43.2 - Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision 43.2 - Application 43.3 - Notices to Commissioner of Patents 43.5 - Marking and …

Medical device meetings draft guidance document: …

https://www.canada.ca/en/health-canada/programs/consultation-medical-device-meetings-draft-guidance/guidance-implementation.html

Medical device meetings draft guidance document: Guidance for implementation Overview Guidance for implementation Appendices On this page Operating principles …

Incident reporting for medical devices: Guidance …

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

An act, or omission of an act, by the user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. Foreseeable misuse …

Health Canada Issues Final Guidance on …

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

This guidance outlines the general principles and criteria for clinical evidence that may be required for Class III and IV license applications or requested for …