Medical devices classification tool draft/

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)