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MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US
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MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US
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mdsap (medical device single audit program), regulatory requirements
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  Post Number #1  
Old 16th August 2017, 02:41 PM
jiligan

 
 
Total Posts: 16
Question MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US

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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  Post Number #2  
Old 17th August 2017, 10:37 AM
kreid

 
 
Total Posts: 57
Re: MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US

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.
Thanks to kreid for your informative Post and/or Attachment!
  Post Number #3  
Old 17th August 2017, 01:50 PM
Edward Reesor

 
 
Total Posts: 83
Re: MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US

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.
Thanks to Edward Reesor for your informative Post and/or Attachment!
  Post Number #4  
Old 25th August 2017, 07:54 AM
jiligan

 
 
Total Posts: 16
Re: MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US

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