Design Philosophy of Class III Medical device in Health Canada require

Lynn Chen

Registered
Hello everyone,

I am preparing a Class III medical device submission for the Canadian market, and I have a couple of questions regarding the "Design Philosophy" section:
  1. For the product description, would including the design rationale, use environment, and material information meet the requirements for "Design Philosophy"?
  2. Since this is the first time we are registering this product in Canada, is it necessary to submit a comparison table with previous device generations, or should we focus on comparing it with competitor products?
Reference: Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)
 
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