Reporting changes to ANVISA

[LFZR88]

Hi All
I'm aware this is an old thread, but I wondered if anyone could help me with a question I have for Brazil. We currently have a Class IIb Medical device product registered in Brazil, but are about to extend the range and therefore would like to add this to the existing registration, can anyone help me with requirements and a timeline for this?
Many thanks

 

[Marcelo]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

You men class III? There?s no IIb in Brazil. Also, if you are trying to extend to a greater risk device, you can?t add to the current registration.

 

[LFZR88]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

Hi Yes sorry I was thinking Europe so Class III for Brazil, we are just adding to the range, the product is exactly the same, but we want to add different sizes to the range

 

[pittmatj]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

I have a similar question for Class I devices, what is required in the "registration change" or filing an "amendment" to the current registration?

 

[Marcelo]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

Hi Yes sorry I was thinking Europe so Class III for Brazil, we are just adding to the range, the product is exactly the same, but we want to add different sizes to the range

So it?s a product family then? For this you would need to have originally registered as a family, otherwise you cannot include a new one.

The way to perform this is to request an alteration/change of the original family registration, you need to pay the change tax and send the documents describing the change, including any other document from the original registration that was changed. For imported device those documents include the updated free sales certificate.

Also, depending on the type of the device, you may be limited in how you can change (for example, for materials there?s a general requirement for families in RDC 14/2011 hat has to me met).

Anyway, this will need to be done by your registration holder, he surely can give you the specific documents required.

 

[Marcelo]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

I have a similar question for Class I devices, what is required in the "registration change" or filing an "amendment" to the current registration?

Only the fee, the front sheet and a new Cadastro form showing the differences. This is the same as the original cadastro. And as in the cue above, you can only do this if the original cadastro was for a family, and you may be limited too, such as the materials example above).

And as above, this will need to be done by your registration holder.

 

[LFZR88]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

Hi Marcelo
Many thanks for your previous advice, I have another question... we have a class III Medical device currently registered with ANVISA that we have made some changes to the labelling, updated the packaging and also a very minor change to the design, which is not a noticeable change. what do I need to inform ANVISA about? your advice would be appreciated.

 

[Marcelo]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

You do not need to inform anything, you registration holder does. For labeling change, they will need to inform ANVISA. The packaging and design changes need to inform will depend if they change any information already sent to ANVISA (it probably does in the case of packaging because of the the information required for registration is the packaging info).

 

[LFZR88]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

Hi Marcelo
Thank you so much for your help, yes sorry I do realise its the registration holder that informs ANVISA, Is the packaging change more important than the design change then? the inner pouch and outer box packaging has changed in size and there is an added insert, but the packaging raw materials have not changed, can you help me to understand how ANVISA will view the changes? or guide me to some information. Many thanks in advance

 

[Marcelo]

Re: IVD ANVISA Registration Process in Brazil and Registration Change

Hi

Well, the design change should be more important, but it does depend on the design change.

The main problem is that there?s different topics for changing that needs to be informed. For example, there?s one for changes in labeling, and another for changes in the commercial presentation. As you further explained that the changes were in the size of the pouch and packaging, they would probably fit in the commercial presentation topic. However, it?s important to verify first if your registration holder did send this information on the original registration, and if so, he would need to update that. If the did not, it would probably be better not to inform anything.

On the case of the device design, it?s the same story, if the change was reported before to Anvisa (usually in the technical file), or if not, but the change deals with safety and efficacy, you would need to report. If not the case, you don?t.

The only real guidance on these topics are in a guidance document, but it?s only in portuguese: MANUAL PARA REGULARIZA??O DE PRODUTOS PARA DIAGN?STICO DE USO IN VITRO NA ANVISA