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Medical Devices Classification Tool/ (view source)
Revision as of 12:28, 18 November 2025
, 12:28, 18 November 2025no edit summary
'''The following guidance documents can be consulted for definitions, examples, and for additional information on how to interpret the classification rules:'''
'''The following guidance documents can be consulted for definitions, examples, and for additional information on how to interpret the classification rules:'''
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices]
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)]
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-vitro.html Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices]
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-vitro.html Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)]
'''''For Software as a Medical Device (SaMD):'''''
'''''For Software as a Medical Device (SaMD):'''''
When using this tool to classify Software as a Medical Device (SaMD), please refer to the SaMD guidance documents below to understand Health Canada's interpretation of terms such as "immediate danger" in this context. You may wish to consult the Medical Devices Directorate to confirm your SaMD classification.
When using this tool to classify Software as a Medical Device (SaMD), please refer to the SaMD guidance documents below to understand Health Canada's interpretation of terms such as "immediate danger" in this context.
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html SaMD: Definition and Classification]
You may wish to consult the Medical Devices Directorate to confirm your SaMD classification.
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html SaMD: Classification Examples]
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html Guidance Document Software as a Medical Device (SaMD): Definition and Classification]
*[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html Guidance Document Software as a Medical Device (SaMD): Classification Examples]
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