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Canada classification of surgical displays, MDL needed?
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Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
Canada classification of surgical displays, MDL needed?
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Canada classification of surgical displays, MDL needed?


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Some Related Topic Tags
class ii medical device, displays (video monitors), endoscopic equipment, health canada
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  Post Number #1  
Old 23rd November 2017, 08:34 AM
emjcatelsm

 
 
Total Posts: 2
Please Help! Canada classification of surgical displays, MDL needed?

Dear forum members,
we are doubting how to interpret Canadian medical device classification rules. There are many brands selling surgical displays e.g. Sony, NDS, EIZO, NEC Displays, TOTOKU (JVC) but is seems that none of them (except Advan) are class II. We do not find a MDL on the Health Canada website.

Does rule 7(2)(b) not apply for surgical displays (that can be connected to class II endoscopes for instance)? What could the rationale be to decide that surgical displays are class I and not class II?
Does anyone know the reasoning behind this?
Thank You!

Eric Caus
Regulatory Officer

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  Post Number #2  
Old 24th November 2017, 04:40 AM
shimonv

 
 
Total Posts: 261
Re: Canada classification of surgical displays, MDL needed?

Hi Eric,
You may not be familiar with the "Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices".

Per this document endoscopic television monitor is class I.
I believe it remains class I even when connected to a class II device because of the electrical safeguards and isolations on the endoscopic machine (including the display port).

Hope it helps.
Shimon
Thanks to shimonv for your informative Post and/or Attachment!
  Post Number #3  
Old 24th November 2017, 06:37 AM
emjcatelsm

 
 
Total Posts: 2
Re: Canada classification of surgical displays, MDL needed?

Thank you very much Shimon, I indeed haven't seen this guidance before. I'll have a look into the categories. kind regards
Eric
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