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

[Marcelo]

This is a continuation of Medical Device Registration Process in Brazil - Anvisa (Part 1) which is a very long thread with almost 300 posts.

Also - If you have a specific question it may be better to start a New Discussion Thread which is specific to your question. That way it will not "get lost in the wilderness" of a 300 post discussion thread.

 

[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]

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.

 

[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).

 

[Marcelo]

It seems your costumer may not be aware of the process.

 

[Bunny]

Are there requirements to have translations to Portuguese certified?

 

[Marcelo]

Nope, only some regulatory documents need to be "certified", not the IFU.

 

[Marcelo]

For those interested, I have created a course for WMDO (WMDO - World Medical Device Organization, which provides online training in several topics related to medical devices) on Registration process for medical device in Brazil - https://www.wmdo.org/course-detail.aspx?id=174.

 

[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]

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 -(broken link removed)

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