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Difference between revisions of "Medical devices classification tool draft/"
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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. | + | '''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.''' |
| + | |||
| + | = [https://forms.office.com/Pages/DesignPageV2.aspx?prevorigin=shell&origin=NeoPortalPage&subpage=design&id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUOEhQWktaRlM0Q0FLSUMyOTBHQVc0U1g0Mi4u&topview=Preview '''Classification Tool'''] = | ||
For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents: | For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents: | ||
| − | + | * [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/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] | |
| − | [https:// | + | * [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)] |
Revision as of 07:21, 12 August 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.
Classification Tool
For additional guidance, explanations and examples of how to apply the classification rules, please refer to the following guidance documents:
- Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
- Guidance Document Software as a Medical Device (SaMD): Definition and Classification
- Guidance Document Software as a Medical Device (SaMD): Classification Examples
- Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
