Looking for Cross Functional Matrix of Medical Device Regulations around the World

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QAengineer13

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#1
#1
I'm in search for a cross functional matrix of regulations around the world, any help in this matter will be much appreciated! I have the mapping of 21 CFR and JPAL ....in search for the the rest of the countries
 
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Ajit Basrur

Ajit Basrur

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#2
#2
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

QAengineer13 said:
I'm in search for a cross functional matrix of regulations around the world, any help in this matter will be much appreciated! I have the mapping of 21 CFR and JPAL ....in search for the the rest of the countries
Click to expand...
What is the purpose of this matrix - are you building the QMS of "around the world" in your existing QMS ?

Marcelo has a valuable post - Guidance for Medical Device Registration in Med Dev Regulations World-Wide in which he has listed all the regulations of different countries. Hope that helps.
 
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QAengineer13

Quite Involved in Discussions
#3
#3
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

Ajit Basrur said:
What is the purpose of this matrix - are you building the QMS of "around the world" in your existing QMS ?

Marcelo has a valuable post - Guidance for Medical Device Registration in Med Dev Regulations World-Wide in which he has listed all the regulations of different countries. Hope that helps.
Click to expand...
Hi Ajit,

Yes, you are correct, that's the idea and thank you to the link for global medical device registration.
 
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Marcelo

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#5
#5
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

shimonv said:
I'm adding a nice comparison chart of QSR, CMDR, MDD, JAPL, and ANVISA.

Cheers,
Shimon
Click to expand...
I think it's important to mention that, although really nice, the ISO, JPAL and ANVISA requirements are old requirements, not current ones.
 
shimonv

shimonv

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#6
#6
Re: Looking for Cross Functional Matrix of Medical Device Regulations around the Worl

Marcelo,
The reason I uploaded the table was to show the similarity between the major markets when it comes to quality system.
I should have stated that in my previous post. Thanks for your comment.

If someone wants to update the table - please do!

Shimon
 
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