Changes

no edit summary
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 ''[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.'''
 
'''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.'''
 +
[[File:Classification Tool.png|thumb|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u]]
 +
 +
 +
   −
[[File:Logo1.png|[https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUNTNISU9QT1YyOUNWRDhNN1g5Wk9RWVVXUi4u Classification Tool]|alt=|center|frameless]][[File:Classification Tool.png|thumb|alt=|[https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4ufication_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.'''
 
'''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.'''
  
70

edits