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  • 1.  Health Canada battery registration

    This message was posted by a user wishing to remain anonymous
    Posted 08-May-2019 10:24
    This message was posted by a user wishing to remain anonymous

    Hello,

    In Canada, our dealer insisted that we need to register our lithium ion battery which is installed in a small device to the Health Canada. 
    - The device is class 2 
    - The battery is exclusively manufactured for that device by outside vendor. 
    - The battery could be sold separately as a replacement parts

    We found a relevant web site (https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/battery-notice-piles-avis-eng.pdf) and it is quite confusing for us. 
    This site says a battery manufacturer must have medical device license (MDL), but what does it mean? 
    We have CMDCAS13485 certificate but don't know about the battery manufacturer. Should they have one?
    The battery should separately registered?

    Any advice is highly appreciated!


  • 2.  RE: Health Canada battery registration

    This message was posted by a user wishing to remain anonymous
    Posted 11-May-2019 19:41
    This message was posted by a user wishing to remain anonymous

    If you are a medical device manufacturer, selling a class 2 device through a Canadian dealer, then I expect you have a MDL for that device. You can check in the MDL database to confirm: https://health-products.canada.ca/mdall-limh/index-eng.jsp. If you a​re also selling a battery (especially for that device) in Canada, it is also considered to be a class 2 medical device, so you can (must) apply for another MDL for the battery.

    Have you already done the transition from CMDCAS to MDSAP? Your auditor will look into your relationship with the battery manufacturer, at least to verify that your agreement ensures an appropriate level of quality.
    Original Message


  • 3.  RE: Health Canada battery registration

    This message was posted by a user wishing to remain anonymous
    Posted 13-May-2019 11:02
    This message was posted by a user wishing to remain anonymous

    Thank you so much for the advice. 

    We have MDL for the device which contains lithium ion battery (and it is a class 2 device). 

    In the Section 28 of Medical Device Regulations, it is described that: 
    Medical Devices Deemed Licensed
    28      If a system is licensed, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to have been licensed. 

    So, based on Section 28, we believed that the lithium ion battery in our device is naturally registered as a part of the device and we should be able to sell the battery as a replacement part of it. 
    However, the web site (https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/battery-notice-piles-avis-eng.pdf) seems to be explaining different procedure for the lithium ion battery and we are wondering if such an exceptional practice is possible in Canada or not.
    Original Message


  • 4.  RE: Health Canada battery registration

    Posted 14-May-2019 09:39
    I couldn't find anything in SOR 98-282 specifically regarding batteries. 

    The way I read the linked PDF is if you are a manufacturer of replacement batteries that are intended to be used in medical devices only (AEDs, hearing aids, etc), then the batteries are considered medical devices themselves and the battery manufacturer has to comply with the regulation.

    If the battery manufacturer is not going to sell the battery in your device separately into the Canadian market only for your device or other medical devices, the regulation does not apply.

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    Joshua Lust
    Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
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    Original Message


  • 5.  RE: Health Canada battery registration

    Posted 14-May-2019 21:05
    Canada has some interesting nuances.

    To be clear, you say that you have a system licence for your product, but that the batteries are manufactured for the product by an outside vendor.  Are the batteries labeled with the system name, with your name as the manufacturer, and were they listed on the license application by name and identifier?  If so, then yes, they are covered by the system license.  If the answers to any of those questions is no, then they need their own license.

    The announcement that you linked to was meant specifically for batteries that are labeled for use with medical products, such as cell batteries labeled as "hearing aid batteries".  But you can still get tripped up if the system name is not on your battery label, or if they are labeled as made by another manufacturer.

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    Rebecca Rice
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    Original Message


  • 6.  RE: Health Canada battery registration

    Posted 15-May-2019 20:48
    Edited by Soichiro Iida 16-May-2019 03:36
    Dear Joshua,
    Dear Rebecca,

    Thank you so much for sharing your insight. 
    The situation seems to be much clearer. 

    Now, I think we shall answer the Health Canada that the lithium ion battery is a part of system and also check if the labels on the battery is appropriate as a part of system.

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    Original Message


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