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Medical Devices Classification Tool/ (view source)
Revision as of 12:06, 18 November 2025
, 12:06, 18 November 2025no edit summary
==Medical Device Classification Tool ==
'''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). It is only intended to classify medical devices that fit 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 indicate that your product is not a medical device, nor that it fits 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.'''
'''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 will **not** determine whether your product is *not* a medical device or if it falls under another category (e.g., drug, consumer product).
Users must confirm that their product meets the definition of a “medical device” before proceeding.
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'''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.'''
<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>
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'''Please note:'''
The tool provides classification guidance **based strictly on your inputs** and should **not** be taken as a final decision by Health Canada.
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==Guidance Documents ==
'''The following documents provide definitions, examples, and additional information:'''
*[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-vitro.html Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices]
'''''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]
*[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]
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