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| − | '''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).''.
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| − | 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.
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| − | It will not determine whether your product is not a medical device or if it falls under another category (e.g., drug, consumer product).
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| − | You will need to determine that your product fits the definition of a “medical device” prior to using this tool.
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| − | ----
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| − | <div style="text-align:center;">
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| − | '<nowiki/>'''''Click below to launch the Classification Tool''''''
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| − | <br>
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| − | [[File:Classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u|alt=Classification Tool|200px]]
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| − | </div>
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| − | ----
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| − | '''Please note:'''
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| − | 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==
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| − | '''The following guidance documents can be consulted for definitions, examples, and for additional information on how to interpret the classification rules:'''
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| − | *[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)]
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| − | *[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)]
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| − | '''''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.'''
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| − | '''You may wish to consult the Medical Devices Directorate to confirm your SaMD classification.'''
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| − | *[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]
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| − | *[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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| − | *
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