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

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DannyK

Trusted Information Resource
#2
Class 1 medical devices in Canada do not require MDSAP. Canada is the only jurisdiction that makes it mandatory to obtain MDSAP.
 

RA_QA_Expert

Involved In Discussions
#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.
 

myusoffice

First Time Right...
#6
Hi, just a word of caution. If you sell your device to any other MDSAP jurisdictions, other than Canada, you have to fulfill those country specific requirements. Your Class 1 device in Canada may be entirely different class in other jurisdiction.

Currently participating jurisdictions in MDSAP:
Australia- TGA
US - FDA
Brazil - ANVISA
Canada - Health Canda
Japan - MHLW
 

Adacus

Starting to get Involved
#9
So just a clarification on element 7.3 we don't have to perform any the following elements. Even if we ship to EU and Canada
 
#10
So just a clarification on element 7.3 we don't have to perform any the following elements. Even if we ship to EU and Canada
Not sure about EU. For Canada, no. That being said, if you are seeking 13485 certification outside of regulatory requirements, then you likely still will in order to comply with the standard.
 
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