Changes

It is only intended to classify products that meet the definition of a “device” in the ''[https://laws-lois.justice.gc.ca/eng/acts/f-27/FullText.html Food and Drugs Act]'' and a “medical device” into Class I, II, III or IV.

It is only intended to classify products that meet the definition of a “device” in the ''[https://laws-lois.justice.gc.ca/eng/acts/f-27/FullText.html Food and Drugs Act]'' and a “medical device” into Class I, II, III or IV.

It will **not** determine whether your product is *not* a medical device or if it falls under another category (e.g., drug, consumer product).   

It will not determine whether your product is not a medical device or if it falls under another category (e.g., drug, consumer product).   

You will need to determine that your product fits the definition of a “medical device” prior to using this tool.

You will need to determine that your product fits the definition of a “medical device” prior to using this tool.

'''The following guidance documents can be consulted for definitions, examples, and for additional information on how to interpret the classification rules:'''

'''The following guidance documents can be consulted for definitions, examples, and for additional information on how to interpret the classification rules:'''

*[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 on the Risk-based Classification System for Non-In Vitro Diagnostic Devices]

*[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-vitro.html Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices]

*[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)]

'''''For Software as a Medical Device (SaMD):'''''

'''''For Software as a Medical Device (SaMD):'''''

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.  You may wish to consult the Medical Devices Directorate to confirm your SaMD classification.

'''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/software-medical-device-guidance-document.html 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/examples.html SaMD: Classification Examples]

 

*[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]

*[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]

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