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Difference between revisions of "Medical Devices Classification Tool/"
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'''''*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.''''' | '''''*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.''''' | ||
| − | * 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-non-vitro-diagnostic.html Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)] |
| − | * 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-document.html Guidance Document Software as a Medical Device (SaMD): Definition and Classification] |
| − | * Guidance Document Software as a Medical Device (SaMD): Classification Examples | + | * [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] |
| − | * Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (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 Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)] |
Revision as of 13:10, 26 August 2025
This tool is intended to assist you with the classification of your medical device by walking through the classification rules found in Schedule 1 of the Medical Devices Regulations. Please note that the tool will provide classification guidance based strictly on how you answer the questions herein. This classification guidance should not be taken as a final decision by Health Canada
Classification Tool
*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.
- Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
- Guidance Document Software as a Medical Device (SaMD): Definition and Classification
- Guidance Document Software as a Medical Device (SaMD): Classification Examples
- Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
