Hearing Aids Labeled as "Used" - Canadian Regulations

L

lightsimage

#1
Hi all,

It's always awkward to write your first post however I'm really happy I've found this site. What a wealth of information!

To those familiar with Canada Medical Device Regulations: Is there a specific requirement (as there is in U.S 21 CFR 801.420 (a) (6) that speaks to "used hearing aids", their control and any special labeling?

I'm wholly unfamiliar with Canadian regulations and don't know where to search.

Thanks so much,
John
 
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DannyK

Trusted Information Resource
#2
I am involved with a client that manufacture hearing aids for Canada but I am unaware of any requirements stated for "used" hearing aids.

I would contact Health Canada to find out the requirements prior to taking any action.

They are easy to deal with and helpful.

Let us know what is the result.
 
L

lightsimage

#3
Danny,
Thanks for information. I will certainly contact Health Canada before arriving at any conclusion on my own!
I'll keep this thread posted, although it may take some time to get firm answers.
 
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