Same Raw Materials, different composition

N

nwong

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
 
G

GPjeri

Did you check out the Notice released Jan 20, 2011 " Guidance for the Interpretation of Significant Change of a Medical Device?" They also released a number of docs effective 4/1/11 related to the change in fees and mention significant changes again. Check out : CanLII - Medical Devices Regulations, SOR-98-282 on the HC site. We are finding the increased need for amendments but with the new fee structure, also fees for significant changes.
 
N

nwong

Did you check out the Notice released Jan 20, 2011 " Guidance for the Interpretation of Significant Change of a Medical Device?" They also released a number of docs effective 4/1/11 related to the change in fees and mention significant changes again. Check out : CanLII - Medical Devices Regulations, SOR-98-282 on the HC site. We are finding the increased need for amendments but with the new fee structure, also fees for significant changes.
Thanks. Do you know if a new product that is just a modification of another product could be marketed in Canada only using an Amendment? Or would filing an Amendment take the old device off the market being replaced with the new device?
 
G

GPjeri

If your new product has a different intended use, then you can not amend but need a new MDLA. I'd suggest emailing HC because depending on the type/class of your current product and the change you may be able to amend. This is the case for some instrumentation where they allow you to 'group.' I've had good luck with emailing them and getting prompt responses.
 
N

nwong

The intended use is the same. I appreciate the assistance, I am sending them an email now.
 
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