Important: The GCConnex decommission will not affect GCCollab or GCWiki. Thank you and happy collaborating!
Difference between revisions of "Medical devices classification tool draft/"
Jump to navigation
Jump to search
Diellza.mati (talk | contribs) |
Diellza.mati (talk | contribs) |
||
| Line 2: | Line 2: | ||
'''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. 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''' | '''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. 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://forms.office.com/ | + | ='''[https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUNTNISU9QT1YyOUNWRDhNN1g5Wk9RWVVXUi4u Classification Tool]'''= |
'''''*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.''''' | '''''*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.''''' | ||
Latest revision as of 10:25, 26 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. 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
Classification Tool
*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.
- 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)
