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Difference between revisions of "Medical Devices Classification Tool/"
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Latest revision as of 11:39, 27 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)
