Who pays Brazil ANVISA Inspection Fees

M

MedinaB

#11
So if a distributor claims to have paid $25.000 for the cadastre of two products we could say that the distributor has difficulty calculating?
 
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M

MedinaB

#13
Question: distributor is not performing as expected/hoped for. Exclusive contract ends dec 31, 2013. Cadastre of products jan 1, 2016. In case we want to change distributor, do we have to cadastre the products again or can we prolong the cadastre but just change name of the distributor? What other options are there - is it possible to add a distributor, for example for a different region?
 

Marcelo

Inactive Registered Visitor
#14
Question: distributor is not performing as expected/hoped for. Exclusive contract ends dec 31, 2013. Cadastre of products jan 1, 2016. In case we want to change distributor, do we have to cadastre the products again or can we prolong the cadastre but just change name of the distributor? What other options are there - is it possible to add a distributor, for example for a different region?
You men registration holder, right? The registration holder can be a distributor, or it can use different distributors.

You need another cadastre, which will be given to the new registration holder.

You should really seek a trustable regitration holder which acts as a partner rather than a service - which is what those consultants offering registrations holder services do, it?s ony a service for them (not sure if this is your case).
 
M

MedinaB

#15
You men registration holder, right? The registration holder can be a distributor, or it can use different distributors.

You need another cadastre, which will be given to the new registration holder.

You should really seek a trustable regitration holder which acts as a partner rather than a service - which is what those consultants offering registrations holder services do, it?s ony a service for them (not sure if this is your case).
In our case the registration holder is also the distributor for Brazil. They are however not selling much (close to zero) and I've just visited them to figure out what the problem is. If ending the agreement with them means we'll need another cadastre, which takes time (up to one year???), and in the meantime we're not present in Brazil. That's not an option for now. So we can say, give the current registration holder exclusive rights for one region (say Rio state), and add another distributor with exclusive rights for another state?

I know we can also let an independent registration company carry the cadastre and they can then allow other companies (indicated by us) to distribute the product as well, right? I heard from someone at Anvisa though that Anvisa wants to end this possibility...
 

Marcelo

Inactive Registered Visitor
#16
If ending the agreement with them means we'll need another cadastre, which takes time (up to one year???)
Should be less, but right now a year is a good estimate, depending on the device.

So we can say, give the current registration holder exclusive rights for one region (say Rio state), and add another distributor with exclusive rights for another state?
A registration holder is by law entitled to sell the device in the Brazilian territory, in the view of Anvisa. So, no.

I know we can also let an independent registration company carry the cadastre and they can then allow other companies (indicated by us) to distribute the product as well, right? I heard from someone at Anvisa though that Anvisa wants to end this possibility...
Yes, this is the usual BRH service that I mentioned before. And yes, Anvisa does not like this kind of service for several reasons. I myself against it, although for a lot of manufacturers it might seem as a great solution (quick and give them options, however in my opinion it's too risk, and they are not warned about the risks),
 
M

MedinaB

#17
A registration holder is by law entitled to sell the device in the Brazilian territory, in the view of Anvisa. So, no.


So we could give our current distributor a non-exclusive distribution agreement, he can then keep the cadastre, and add other companies as well as non-exclusive distributors, but they would have to cadastre the products as well? Of course we don't want various companies working in the same region (then we 'd get a price war), so we'd have to arrange that with them separately I guess.
 

Marcelo

Inactive Registered Visitor
#18
So we could give our current distributor a non-exclusive distribution agreement, he can then keep the cadastre, and add other companies as well as non-exclusive distributors, but they would have to cadastre the products as well? Of course we don't want various companies working in the same region (then we 'd get a price war), so we'd have to arrange that with them separately I guess.
Yes, you can have another registration holder, but he will need to perform another cadastre. You probably would need to cut your first one in some way (but maybe it's not possible due to your agreement).

Please note that your agreement with your registration holder is something outside the regulatory aspect.
 
M

MedinaB

#19
I am a bit confused now, complicated as it all is.

You said that class II products only need cadastre. How about class I? The products are tampons (for nose and ear), one is qualified as class I, the other as class II (don't know why, same principle).

According to the distributor and cadastre holder both products have cadastre, no need for registration (I just want to be sure, since you said cadastre for class II).

So my question is, can products class I also qualify for cadastre? And cadastre means also that no B-GMP-audit/certification is needed?
 

Marcelo

Inactive Registered Visitor
#20
You said that class II products only need cadastre. How about class I? The products are tampons (for nose and ear), one is qualified as class I, the other as class II (don't know why, same principle).
The general rule is - cadastre for classes I and II, registration for classes III and IV. There's some classes I and II that still need registration - they are on an exception list - IN 02/2011.

If they are classes I and II, they are probably under cadastre, because they probably are not on the exception list (well, it depends on what they are made of). What are they made of? And what is the intended use of these tampons?


So my question is, can products class I also qualify for cadastre? And cadastre means also that no B-GMP-audit/certification is needed?
Yes and yes.
 
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