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Difference between revisions of "Medical Devices Classification Tool/"
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| − | '''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]''. | + | '''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 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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<div style="text-align:center;"> | <div style="text-align:center;"> | ||
'<nowiki/>'''''Click below to launch the Classification Tool'''''' | '<nowiki/>'''''Click below to launch the Classification Tool'''''' | ||
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[[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]] | ||
</div> | </div> | ||
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'''Please note:''' | '''Please note:''' | ||
| − | The tool | + | 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 | + | '''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 on the Risk-based Classification System for Non-In Vitro Diagnostic Devices] | ||
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'''''For Software as a Medical Device (SaMD):''''' | '''''For Software as a Medical Device (SaMD):''''' | ||
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| + | 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 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 SaMD: Definition and Classification] | ||
Revision as of 12:23, 18 November 2025
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 (the Regulations).
It is only intended to classify products that meet the definition of a “device” in the 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.
'Click below to launch the Classification Tool'
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:
- Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices
- Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices
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.
