MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US

jiligan

Involved In Discussions
#1
The MDSAP Audit Model states - Verify the organization has complied with regulatory requirements to register and/or license device facilities and submit device listing information in the appropriate jurisdictions where the organization markets or distributes devices. If a company has products registered in countries other than Japan, Brazil, Australia, Canada or US, do they have to show documentation of registration in those countries or will the notified body only ask to verify for the five countries participating in the Medical device single audit program?
 
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kreid

Involved In Discussions
#2
My guess would be that they would epect you to have a process for this (device facilities registration) that would capture all cases)and that they would look for evidence that you have applied the process to the five MDSAP countries, as appropriate.
 

Edward Reesor

Trusted Information Resource
#3
I believe that's correct in that you should have a SOP that states that you will follow the respective jurisdiction's rules and regulations wherever the product will be sold or distributed.
 
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