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Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Marcelo Antunes

Addicted to standards
Staff member
Admin
#91
You are probably confused by the line below:

The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and other MDSAP participants and members who wish to understand MDSAP QMS.
It means that, if you are a stakeholder that wants to understand how the MDSAP program QMS is structured, you should read this manual. Maybe it could have a better wording, but that´s another matter.
 

somashekar

Staff member
Super Moderator
#92
How does the ANVISA BGMP inspection go about.
Does the ANVISA inspector follow a path similar to what the FDA follows., like the QSIT...
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#93
How does the ANVISA BGMP inspection go about.
Does the ANVISA inspector follow a path similar to what the FDA follows., like the QSIT...
NO, they do not have a inspection guidance. It?s a little more open, they usually use RDC 16 directly.
 

tibon74

Involved In Discussions
#94
Hi Guys,

I'm working on an economic information report (RDC185/2006) to be submitted to Nurem. I should put tax aliquot for France, Spain...what does it means ?
Thank you !!
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#95
Hi Guys,

I'm working on an economic information report (RDC185/2006) to be submitted to Nurem. I should put tax aliquot for France, Spain...what does it means ?
Thank you !!
You need to declare the factory price with a breakdown of taxes and distribution margin, with proper proof of source from where this information comes. This is for the country of origin of the product and also applies to the list of countries, if the case.
 
#97
Hi Roland,
For translated regulations EMERGO has been generous and provided English versions on their site. Click on the Brazil link which will take you to multiple Brazil resources including the regulatory approval process. Find the link to the library (click on menu) then Brazil. This is where the translated regulation are located.
Regards,
Glenn
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#98
Hi Roland,
For translated regulations EMERGO has been generous and provided English versions on their site. Click on the Brazil link which will take you to multiple Brazil resources including the regulatory approval process. Find the link to the library (click on menu) then Brazil. This is where the translated regulation are located.
Regards,
Glenn
They are a good initial resource, but I would read any document with care. I've seen several translation and interpretation errors in several documents.
 
#99
Thanks for the heads up. Also even though they are in English the translation does make it a bit difficult to interpret. You can get a good general understanding of what the regulations are requiring.
 
Hi Marcelo,
I have read the translated regulations and could not find anything that addresses my specific question so I hope you can provide some guidance. I am in process of obtaining INMETRO certification and a question has come up in regards to language requirements.

The regulations make it very clear that the IFU must be in Portuguese. What is not clear to me is if a medical device has an electronic display that provides information to the user if that information is required to be in Portuguese. The display provides information such as various controls, testing, various preset programs, treatment times, power output parameters etc.

Thanks,
Glenn
 
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