CMDR Essential (Safety & Effectiveness) Requirements Checklist?

cmeby

Involved In Discussions
#1
We recently completed our MDSAP audit with Canada, USA, Australia and Europe in scope.

As part of the Country Specific requirements, we have the checklists/template for Essential Requirements for Europe and Australia.
Our auditor asked me for one for Canada.(CMDR 10-20 S&E reqts) There is no template and I am looking to see if anyone has made one....?

I did not get an NC since the requirements were documented in my procedures, but our auditor indicated it is something he would look for next visit.

Does anyone have anything like this?
 
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Ellison

Starting to get Involved
#3
Good Morning,
Did the auditor provide an explanation as to what was driving this expectation? A sister site got a NC because they had specific references in their procedures to the regulations but did not include all regulations 5 regulations. The auditor never mentioned needed a CMDR check sheet though in their audit or ours. Two separate notified bodies.


Thanks
Ellison
 

yodon

Leader
Super Moderator
#4
I don't want to answer for @cmeby but the internal audit requirements for 13485 say (emphasis added) that the assessment of the QMS:

a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements;

It's my understanding that this would include requirements from all jurisdictions where they sell; e.g., Canada.
 

cmeby

Involved In Discussions
#7
The reason we did not get an NC is because there is no specific requirement or template for the checklist. However, there is a requirement to have objective evidence the requirements for Canada have been considered and complied with. (as Yodon outlined above) This is not clear and easy to do. Having them outlined in your procedures is not enough.
Since we have the checklists for other countries in the MDSAP program, it was our auditors strong suggestion that having one for Canada as well would fit in well to the whole MDSAP picture for the next audit.
I think it is a good way of doing it, so I shared the information and my result.
 

Ellison

Starting to get Involved
#8
Interesting, the auditors logic makes sense. Thanks for the insight. Do you also have check sheets for Japan and Brazil or do you not sell there?

Thanks
Ellison
 
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