Important: The GCConnex decommission will not affect GCCollab or GCWiki. Thank you and happy collaborating!
Difference between revisions of "Medical Devices Classification Tool/"
Jump to navigation
Jump to search
Diellza.mati (talk | contribs) |
Diellza.mati (talk | contribs) |
||
| Line 1: | Line 1: | ||
| − | '''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 ''[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.''' |
| − | |||
| − | |||
| − | * [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)] | + | '''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.''' |
| − | * [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] | + | <center><div class="mw-ui-button mw-ui-progressive"> |
| − | * [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)] | + | [https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUNTNISU9QT1YyOUNWRDhNN1g5Wk9RWVVXUi4u Classification Tool] |
| + | </div> | ||
| + | </center> | ||
| + | |||
| + | *[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://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 10:58, 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 medical devices that fit 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 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.
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.
- 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)
