IFU for Canada Class III Medical Device

S

Slayer_ch

Hello,

We are working on a new IFU for a Class III Medical Device. For Canada had a long discussion about the Content of the IFU.

Does anybody know where I can find if we have to include Clinical Data in the IFU for a Class III Medical Device?

Is there a nice overview for Canada / Europe what the Content has to be in an IFU for a Class III Medical Device?

Thanks all for your help.
 

sreenu927

Quite Involved in Discussions
Hii..

I have this notes which presents details of US,EU and Health canada QSR information.

As of my knowledge, no need to include Clinical data in IFU. Recently, I ahve prepared IFU for our Class III(as per EU-CE Marking) medical device, where no clinical data was included.
However, you can check it out from our other experienced Covers.

Thanks,
Sreenu
 

Attachments

  • QSR_CE_US_Canada.pdf
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T

tamale

I sugest you go to the Health Canada web site, there are phone numbers for information, leave a message, they always call back.

They have been very helpful to me!

:)

Tamale
 
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