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Medical devices classification tool draft/ (view source)

Revision as of 07:16, 12 August 2025

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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 Medical Devices Regulations.

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For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents:

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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://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUOEhQWktaRlM0Q0FLSUMyOTBHQVc0U1g0Mi4u Classification_Tool_Draft]~~

[https://forms.office.com/Pages/DesignPageV2.aspx?prevorigin=shell&origin=NeoPortalPage&subpage=design&id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUOEhQWktaRlM0Q0FLSUMyOTBHQVc0U1g0Mi4u&topview=Preview Classification Tool]

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