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Medical Devices Classification Tool/ (view source)
Revision as of 12:36, 1 December 2025
, 12:36, 1 December 2025no edit summary
'''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 ''[https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/FullText.html Medical Devices Regulations] (the 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 ''[https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/FullText.html Medical Devices Regulations]''.
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.
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'<nowiki/>'''''Click below to launch the Classification Tool''''''
'<nowiki/>'''''Click below to launch the Classification Tool''''''
[[File:Classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u|alt=Classification Tool|200px]]
[[File:Classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u|alt=Classification Tool|200px]]
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'''Please note:'''
'''Please note:'''
The tool provides classification guidance **based strictly on your inputs** and should **not** be taken as a final decision by Health Canada.
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
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==Guidance Documents ==
==Guidance Documents==
'''The following documents provide definitions, examples, and additional information:'''
'''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):'''''
*[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]
'''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/examples.html SaMD: Classification Examples]
'''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]
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