Canada classification of surgical displays, MDL needed?

E

emjcatelsm

#1
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
 
Elsmar Forum Sponsor
E

emjcatelsm

#3
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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