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:
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:
- For the product description, would including the design rationale, use environment, and material information meet the requirements for "Design Philosophy"?
- 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?