Changes

'''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'''

'''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/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUNTNISU9QT1YyOUNWRDhNN1g5Wk9RWVVXUi4u 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.'''''

'''''*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)]