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

Hi Marcelo,

Thanks so much for everything you've contributed to these threads. I'm maybe starting to get picture of Brasil and medical devices.

A little bit deeper on the BHR - I'm relatively new to standards and so I have to rely a bit on marketing's experience and I've been told that although "theoretically" we are only supposed to have a single BHR, in practice everyone has multiple BHRs (and unlike your prior response - they intend them to be permanent/semi-permanent). This doesn't fit with everything I've read here and been able to find elsewhere.

My recommendation was to not use one (or multiple) distributors as our BHR but we could contract with someone who only served that function (e.g. Emergo - among many others which are probably less expensive). Alternatively, we could set up a company in Brasil but I think that investment, risk, complexity is too high as I've heard of some nightmare stories with Brasilian taxing authorities.

I also have told them I thought that having one BHR who is a distributor is effectively granting them exclusive distribution rights and if we want to change BHR, they can cause us problems.

What are your thoughts?

supadrai said:

in practice everyone has multiple BHRs (and unlike your prior response - they intend them to be permanent/semi-permanent). This doesn't fit with everything I've read here and been able to find elsewhere

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I'm not sure where this comes from. In fact, right now it's even more problematic to have this because the importer has to have a declaration from the manufacturer giving express authorization for the importer to represent and market their products in Brazil. Are you sure your are not confusing the BHR with the distributor (which manufacturers really have more than one)?

supadrai said:

My recommendation was to not use one (or multiple) distributors as our BHR but we could contract with someone who only served that function (e.g. Emergo - among many others which are probably less expensive).

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That's what most do.

supadrai said:

Alternatively, we could set up a company in Brasil but I think that investment, risk, complexity is too high as I've heard of some nightmare stories with Brasilian taxing authorities.

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This is the best solution from a business risk perspective, but obviously more complex.

supadrai said:

I also have told them I thought that having one BHR who is a distributor is effectively granting them exclusive distribution rights and if we want to change BHR, they can cause us problems.

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Yes, in practice it's what happens, because they would not want to give importing signatures to other distributors.

Finally, please bear in mind that, since the publication of RDC nº 102/2016, registrations and cadastros can be "sold"under commercial operations (prior to that, it could only be done thru fusions or mergers), so now it's easier to change holders if you require, for example by contract, that the holder "sells" the registration if you require it to.

I'm sure they're talking multiple BHRs - essentially they think that making each distributor a BHR is a workable solution. Previously, our JV partner handled the Brasilian market with a controlled entity acting as the BHR but now it's ours.

Hi Marcelo,

We are in a plan to register medical equipment used to reduce localized fat through the epidermis in such a way that lipid-rich cells can be eliminated from the body by means of natural metabolic processes. The product in scope is the New generation product of the Existing Product (already registered with ANVISA).The main difference from the previous medical equipment consists on the inclusion of the possibility to use four hand pieces simultaneously.

I have few questions regarding product registration procedure in Brazil. I would be glad if you can answer them.

The product that has to be registered in Brazil is not registered in any of the country.

1.Can you please confirm whether it is possible to register the product without other country approvals.
2.Can we use the existing old generation product as predicate?
3.Is INMETRO testing required?
4.Is Clinical data required for the New generation product that to be registered?
5.Is there any abridged process to register this product as technology and intended use is similar?
6.What are all the documents required for the product registration?
7.Is BGMP required as the old generation product that registered also get manufactured at same premises?

Thank you very much in advance.
Regards,
Mallappa

Hello, and welcome to the Cove!

1.Can you please confirm whether it is possible to register the product without other country approvals.

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Yes.

2.Can we use the existing old generation product as predicate?

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Brazilian regulation does not use the concept of predicate.

3.Is INMETRO testing required?

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If it's a medical electrical equipment under IEC 60601 (it seems it is), yes.

4.Is Clinical data required for the New generation product that to be registered?

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Can't say with certainty. If it's class III or IV, ANVISA may required clinical data.

5.Is there any abridged process to register this product as technology and intended use is similar?

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No.

6.What are all the documents required for the product registration?

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Too many to list, and it really depends on the product. What I always suggest is to create a regulatory strategy plan for the product which includes, between other things, a list of required documentation.

7.Is BGMP required as the old generation product that registered also get manufactured at same premises?

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If class III or VI, yes. In principle, you can use the GMP already granted, if ANVISA accepts that.

Thanks so much Marcelo

Really appreciate your quick response.

Hi Marcelo! We are planning to market IVD product in Brazil. For IVD product (Class III based on RDC 36/2015) to register with ANVISA, can we go for the ABIMED route? I saw a post mentioning about "CBDL route", could you share with me what that is? How long will the registration take?

Hello, and welcome to the Cove!

tifff said:

Hi Marcelo! We are planning to market IVD product in Brazil. For IVD product (Class III based on RDC 36/2015) to register with ANVISA, can we go for the ABIMED route? I saw a post mentioning about "CBDL route", could you share with me what that is? How long will the registration take?

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Both ABIMED and CBDL has injunctions granted that enable them to speed up the GMP inspection, thus speeding the GMP certificate publication. I'm not sure right now if you can use either, because the injunctions were received some years ago, and did not contemplate new associates. You should talk to them to verify.

Registro for IVDs is taking some 60 days.

Mallappa said:

Thanks so much Marcelo

Really appreciate your quick response.

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Hi Marcelo,

One of my colleague has mentioned that to be able to register in Brazil it has to have a registration somewhere else.

It can’t be registered in Brazil without it, since we need official documentation from the regulatory body of the country where it is registered to submit in the registration dossier in Brazil.

It would be great help if you could provide reference (RDC or Decreto) to confirm whether it is possible to register the product without other country approvals.

Can you please confirm whether FSC/any other approval is mandatory to enter in to Brazil? 2956 - EQUIPAMENTOS PARA A SAÚDE: REGISTRO, CADASTRO E LEGISLAÇÃO, assuming the INMETRO certification will replace the FSC.

Thanks and Regards

Mallappa said:

Hi Marcelo,

One of my colleague has mentioned that to be able to register in Brazil it has to have a registration somewhere else.

It can’t be registered in Brazil without it, since we need official documentation from the regulatory body of the country where it is registered to submit in the registration dossier in Brazil.

It would be great help if you could provide reference (RDC or Decreto) to confirm whether it is possible to register the product without other country approvals.

Can you please confirm whether FSC/any other approval is mandatory to enter in to Brazil? 2956 - EQUIPAMENTOS PARA A SAÚDE: REGISTRO, CADASTRO E LEGISLAÇÃO, assuming the INMETRO certification will replace the FSC.

Thanks and Regards

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RDC 185/2001 requires the registration or free trade certificate or equivalent document issued by the competent authority of countries where the medical device is manufactured and / or marketed.

You can also use the INMETRO certificate in lieu of the FSC, as mentioned.