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Classification des Instruments Médicaux/ (view source)
Revision as of 13:22, 17 February 2026
, 17 FebruaryCreated page with " '''Cet outil vise à vous aider à déterminer la classification de votre instrument médical en vous guidant à travers les règles de classification prévues à l’annexe..."
'''Cet outil vise à vous aider à déterminer la classification de votre instrument médical en vous guidant à travers les règles de classification prévues à l’annexe 1 du Règlement sur les instruments médicaux (le Règlement).''.
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).
You will need to determine that your product fits the definition of a “medical device” prior to using this tool.
----
<div style="text-align:center;">
'<nowiki/>'''''Click below to launch the Classification Tool''''''
<br>
[[File:Classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u|alt=Classification Tool|200px]]
</div>
----
'''Please note:'''
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
----
==Guidance Documents==
'''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 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 Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)]
'''''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.'''
*[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]
*
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).
You will need to determine that your product fits the definition of a “medical device” prior to using this tool.
----
<div style="text-align:center;">
'<nowiki/>'''''Click below to launch the Classification Tool''''''
<br>
[[File:Classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u|alt=Classification Tool|200px]]
</div>
----
'''Please note:'''
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
----
==Guidance Documents==
'''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 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 Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)]
'''''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.'''
*[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]
*
