Reporting changes to a Class II Medical Device in Canada

tehuff

Involved In Discussions
#1
Hi- I know there are similar posts to this one, but I am hoping to get some "real world" insight. I need to develop a process for assessing changes to a Class II device in Canada (and the US and EU but I think I have those under control :)). I know what the Canadian Medical Device regulations state with regards to when license amendments are required for Class II devices - here are my questions:
1) Will following the 510k guidance for the US get me close with regards to Canada? At first glance, this appears to be almost too conservative for Canada per what they state in their regulations. What is your real world experience?
2) The company also has Class III products in Canada so will be detailing that process as well per the Significant Change guidance. Seems pretty straightforward - correct?

:thanx:
 
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Stijloor

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#2
Re: Reporting changes to Class II Mdical Device in Canada

A Quick Bump!

Can someone help?

Thank you very much!!
 

Marc

Hunkered Down for the Duration with a Mask on...
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#3
Re: Reporting changes to Class II Medical Device in Canada

Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 
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