Medical Device Registration Process in Brazil - Anvisa (Part 2)

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D

Dudes

#2
Re: Medical Device Registration Process in Brazil - Anvisa

As an OEM manufacturer (EU class III devices), I have received a request from one of our customers that we should register our company by ANVISA.

I thought only the legal manufacturer had to register the products. (after successfully passing a GMPS audit which can only be requested by a subsidiary/partner in BR). Am I wrong?

What is the procedure to register the company? I could not find any information on how to do it..

Thanks for your help!
 

Marcelo

Inactive Registered Visitor
#3
Re: Medical Device Registration Process in Brazil - Anvisa

I thought only the legal manufacturer had to register the products. (after successfully passing a GMPS audit which can only be requested by a subsidiary/partner in BR). Am I wrong?
Yes, because not even the legal manufacturer can register the product if he?s outsite of brazil. Only Brazilian entities can register products in Brazil.
 
D

Dudes

#4
Thank you for your answer Marcelo.

Yes, because not even the legal manufacturer can register the product if he?s outsite of brazil. Only Brazilian entities can register products in Brazil.
I am aware that only Brazilian entities can register products there (that is why I said that it has to be requested by a subsidiary/partner).

And this is why I don't get how we could get registered as OEM supplier by ANVISA (we are in Europe).
 
E

emron428

#9
Registration Fee with ANVISA

Is there a listed set of fees, costs and time limits for registering a certain product with ANVISA, depending on their classification? There is none readily apparent on ANVISA's webpage and the closest compilation I could find was a price matrix with data from 2002, which I'm sure has changed by now.
 

Marcelo

Inactive Registered Visitor
#10
Is there a listed set of fees, costs and time limits for registering a certain product with ANVISA, depending on their classification? There is none readily apparent on ANVISA's webpage and the closest compilation I could find was a price matrix with data from 2002, which I'm sure has changed by now.
ANVISA fees - yes, it's on Annex 1 of RDC 222/2006 -http://www.anvisa.gov.br/legis/resol/2006/rdc/222_anexo1.pdf

Costs and timelines, not from ANVISA. But see attached file.
 

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