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Reclassification of a Medical Device by Health Canada

Sheemah

Starting to get Involved
#1
Hi Everyone,

What could be the possible ramifications if Health Canada chooses to reclassify your device from Class-I to Class-II?
We already have an Quality Management system in place and are ISO 13485 certified.

It would be great if someone has experience with reclassification of devices in Health Canada.

Thanks for help in advance.

Sheemah:D
 
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Sheemah

Starting to get Involved
#3
Re: Reclassification of Device by Health Canada

Hi Sidney,

Thank for the reply, but the reclassification discussed in this thread is inregards to FDA and not Health Canada.
I am not able to find any thing about what could be the possible outcome ,if Health Canada chooses to reclassify your device from Class-I to Class-II & what could be the possible ramifications of that?

Thanks,
Sheemah
 

DannyK

Trusted Information Resource
#4
If Health Canada reclassified the medical device from class I to class II, the requirement for getting a class II license applies. This means that you have to get your quality system certified to ISO 13485:2003 + CMDCAS requirements.
 

mihzago

Trusted Information Resource
#5
I just went through that exact process.
If you already have the ISO 13485 cert (make sure you have the CMDCAS designation, or MDSAP), then you should only have to submit a New Class 2 Medical Device Application.
 
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