Changes

[[File:Screenshot 2025-01-28 153306.png|thumb|177x177px]]

[[File:Screenshot 2025-01-28 153306.png|thumb|177x177px]]

'''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.'''      

'''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'''        

='''[https://forms.office.com/r/uuGZEqtiBi Classification Tool]'''=   

='''[https://forms.office.com/r/uuGZEqtiBi Classification Tool]'''=   

For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents:

'''''*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/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-non-vitro-diagnostic.html Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)]