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Does Class 1 Medical Device need to be certified to MDSAP?

#2
Class 1 medical devices in Canada do not require MDSAP. Canada is the only jurisdiction that makes it mandatory to obtain MDSAP.
 
#3
Manufacturers of MD class I don´t need MDSAP certificate. MDSAP certificate is requested during licensing proces with Health Canada, but class I is exempt from licensing.

if you are not from Canada be aware, that classification is different from other countries and you need to meet technical standards recognized by Health Canada.
 
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