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

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Dudes

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
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

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).
 
B

Bunny

Are there requirements to have translations to Portuguese certified?
 
E

emron428

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
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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  • ANVISA costs and timeframes - medical devices V1.pdf
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