Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)

"caso o produto ou parte dele seja produzido por terceiro, rela??o informando raz?o social e endere?o completo da(s) empresa(s) envolvida(s), e etapas correspondentes no processo de fabrica??o". we will need to describe the manufacturing and provide the list of subcontractor?

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Yes.

What does "c?pia do Certificado de Conformidade emitido no ?mbito do Sistema Brasileiro de Avalia??o da Conformidade (SBAC), aplic?vel apenas para os produtos m?dicos com certifica??o compuls?ria, relacionados pela ANVISA em regulamentos espec?ficos;" mean ?

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The INMETRO certificate.

so, it is not simplification of the process! On the contrary, the cadastre will be very hard...
For INMETRO certificate, we will need it for all class I and II ?

The requirement for the INMETRO certificate are for the products which already have an INMETRO certificate requirement, so there?s nothing new here.

many thanks
a last question, what does "conhecimento e atendimento aos requisitos de Boas Pr?ticas de Fabrica??o de Produtos para Sa?de estabelecidos na Resolu??o – RDC/ANVISA n? 16, de 28 de mar?o de 2013, ou outra legisla??o que venha substitui-la" mean?

what does "conhecimento e atendimento aos requisitos de Boas Pr?ticas de Fabrica??o de Produtos para Sa?de estabelecidos na Resolu??o ? RDC/ANVISA n? 16, de 28 de mar?o de 2013, ou outra legisla??o que venha substitui-la" mean?

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Oh, this is curious. You don?t need a GMP certificate anymore, but the manufacturer and importer still has to comply with GMP requirements, so this stuff is in practice a statement that you know and complies with RDC 16.

thank you!
I was scared! I understood that we will should provide B-GMP for the subcontractors...
by manufacturer, Are you talking about the legal manufacturer or subcontractor?

by manufacturer, Are you talking about the legal manufacturer or subcontractor?

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Anyone to which the requirements of RDC 16 applies.

Marcelo Antunes said:

By Brazilian regulations, the registration holder in Brazil is fully responsible for the devices, so no, you cannot be the "representative for the manufacturer in the US".

You can also label the device the way you want. However, you need to have the information that the design information that proves the safety end efficacy of the device, because it?s part of the registration process and you will need to send those to ANVISA (or keep them, depending on the type of device).

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So what is the difference between the representative that I read about (is this if the manufacturer wants to register it themselves?) and being responsible for the product thst you mentioned (is this if a company in Brazil is registering a US product?).

These products are FDA approved and have been selling for a few years now, so all of the safety and efficacy documents are available. The products are spine implants. I was told that the documents for the implants sent to ANVISA must have the labeling match the FDA documents, so to relabel the product we must do testing over again. I would love for us (my Brazilian partner and I with our Brazilian office) to register the products in our name (this would give us exclusive selling opportunities in Brazil) and label the spine implants with our logo with no extra testing and/or major documentation to prepare. We will be selling these and other products throughout South America and would like to build our brand and not each individual US companies brand (it also makes us look more professional selling one brand vs 3-4 different brands).

Thanks,
Steven

So what is the difference between the representative that I read about (is this if the manufacturer wants to register it themselves?) and being responsible for the product thst you mentioned (is this if a company in Brazil is registering a US product?).

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Maybe the confusion is because you have to have a letter of permission from the original manufacturer? But this does not mean you are a representative (a lot of people do not understand this distinction, and I?ve heard a lot of times people thinking, erroneously, that the Brazilian importer is a representative).

I was told that the documents for the implants sent to ANVISA must have the labeling match the FDA documents, so to relabel the product we must do testing over again.

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You don?t, but you need to clearly show that the device you relabeled is the same one from the related documentation (and that updates are reflected, etc.). Part of the actual problem is that a lot of time sit?s not clear to ANVISA that the documentation is really for the device.

ok thank you !