Health Canada Class II devices - exempt from design controls? Section 7 of 13485

D

Drazha

#1
Greetings,
I had a quick look through the forum for this, but didn't find the answer I wanted - apologies in advance, as I'm sure this is well understood by most people.
I remember hearing that Class 2 devices in Canada were exempt from some aspects of sec. 7 of 13485. Is this true? If so, which aspects?
 
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Al Rosen

Staff member
Super Moderator
#2
Drazha said:
Greetings,
I had a quick look through the forum for this, but didn't find the answer I wanted - apologies in advance, as I'm sure this is well understood by most people.
I remember hearing that Class 2 devices in Canada were exempt from some aspects of sec. 7 of 13485. Is this true? If so, which aspects?
I don't think so, unless it is sec 7.5.3.2, Traceability.
 
D

Drazha

#3
Thanks for the help. Being relieved of misinformation is always a good start! I think what I heard (or misheard) was that ISO 13488 was going to be phased out and that 13485 would replace it, but with some exclusions. Since you're saying that design controls (product realization) is a necessary part of any 13485 certification, is it correct to say that the regulations got tighter when 13488 was phased out?
 

gdwaikle

Involved In Discussions
#4
Drazha

Al is correct Class II devices are not exempt. You should visit the Health Canada Web site to get all the latest information related to Canada. Health Canada has four classes not three as we do here and in the EU. In addition you will find out that Class 1 devices are exempt, that is if you are strictly a
Class I MFg. you cannot get registered in Canada as a medical device manufacturer. If you make both Class I and anything higher than that you must be registered and follow all the Canadian import requirements.
 
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