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Shanshan (Samantha) Chen (ASQ CQA)
RA/QA professional in Medical devices industry, seeking to new opportunity.
August 2016
Any labelling requirement for medical device’s Wi-Fi function in Canada?
< 1 min reading time

Do anybody know that is there any labelling requirement for medical device’s Wi-Fi function in Canada? I check the label regulation and they did not mention Wi-Fi, thanks!

source: https://www.linkedin.com/groups/2070960/2070960-6176002121310175232

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Posted by Shanshan (Samantha) Chen (ASQ CQA)
Asked on August 29, 2016 12:00 am
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Rob Packard The guidance I found was for exposure limits: http://www.hc-sc.gc.ca/ewh-semt/consult/_2014/safety_code_6-code_securite_6/final_finale-eng.php. Health Canada has their list of recognized standards, and IEC 60601-1 covers labeling. I found no other mention. You could always send an email to the device licensing division. They are very helpful and if there is a problem with your labeling they would have you revise the labeling and email them the updated labeling before approving the labeling. This is why labeling must be submitted along with the licensing application.
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David Meeks All wireless devices sold in Canada, including medical devices with wireless connectivity, need to be registered with Industry Canada (not Health Canada) for RF certification. I'm not sure what device labeling requirements are included, but I know there are some requirements for user guide content. Recommend investigating Canadian RF certification through Industry Canada.
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Al Christie Hi, Since wifi is an intentional radiator there are specific requirements for certification. In the US the FCC has authority for compliance with CFR part 15, in Canada it's Industry Canada (IC). The certification requires appropriate tests, specifications and labelling.
You should go further and also test for EMC (unintentional transmission, etc) to IEC60601-1-2.
These will all contribute to your medical device validation.

Hope that helps
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Mia Spiegelman BSc, RAQC Check other regulatory bodies - your label will have to comply with not only Health Canada but also other regulations such as electrical etc. At a recent MEDEC conference there was a person from Blackberry speaking about data security for these types of devices. You may want to look at the division that regulates cellphones etc
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Shanshan (Samantha) Chen (ASQ CQA) Thanks Robert, it is a very useful information. I never asked the questions to device licensing division, maybe I need to try it next time. Thanks again.
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Shanshan (Samantha) Chen (ASQ CQA) Thanks for all your input, I will look at the information from IC, glad to know this .
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