N
Greetings,
I was searching through Health Canada's site for a guidance document similar to fda's When to submit a 510(k) to no avail. I was hoping someone from this forum might be able to help me with a link to an equivalent document or with some first hand experience in this category.
We have a medical device already registered in Canada that has the exact same raw materials as another one of our devices, only difference is in the composition of the raw materials. Not a huge difference, but there is one. What I am trying to find out is if I need to submit a whole new Class III medical device application for this device or if Health Canada has another process for this type of situation. Any help here is greatly appreciated. My thanks in advance.
Nick
I was searching through Health Canada's site for a guidance document similar to fda's When to submit a 510(k) to no avail. I was hoping someone from this forum might be able to help me with a link to an equivalent document or with some first hand experience in this category.
We have a medical device already registered in Canada that has the exact same raw materials as another one of our devices, only difference is in the composition of the raw materials. Not a huge difference, but there is one. What I am trying to find out is if I need to submit a whole new Class III medical device application for this device or if Health Canada has another process for this type of situation. Any help here is greatly appreciated. My thanks in advance.
Nick