IVD Classification in Brazil and Anvisa Guidance

[Paperman]

One of the many problems I have is that I don't know how to determine the classes of the IVDs our company produces. We produce HLA-tissue typing reagents for the use of sequencing based typing (SBT) and software to analyse the sequences produced with these reagents. The resulting typings are assist health care professionals in determining the match between donor and acceptor.

As far as I have come to understand, there are two kinds of classifications:
1) group classification
2) risk classification

1) Group classification:
From Annex II of "Administrative Order n. 8/MS/SVS, of January 23, 1996(*)", I conclude that our product belongs to group A.

Then there is "RESOLUTION ‐ RDC N º 185 FROM OCTOBER 22, 2001
Republished in the D.O.U, 11/06/2001" which does not mention group classifications but has its own classification which is not clear to me

2) As for risk classification, I found: "Consulta de Nomes Técnicos - Produtos Diagnósticos de uso in-vitro". This does not mention HLA SBT but only HLA SSP, which is not completely the same. However I assume that our products are risk class III.

Nevertheless it's all very confusing. If I don't know what categories, groups or whatever the parameter may be, I don't know the regulatory requirements that have to be met.

Furthermore I don't understand how software can be subject to GMP. To me GMP is for laboratory activities for reagents, be it r&d or production, and not software.

Thanks in advance for the information.

Kind regards.

 

[Marcelo]

Re: Future revision of ANVISA RDC 59 - Brazilian GMP

Hi

The classification scheme for IVDs can be found in Resolução de Diretoria Colegiada - RDC nº61 de 18 de novembro de 2011 - Dispõe sobre as regras de classificação dos produtos para diagnóstico de uso in vitro e dá outras providências.

Furthermore I don't understand how software can be subject to GMP. To me GMP is for laboratory activities for reagents, be it r&d or production, and not software.

GMP, as any quality system, can be applied for everything, including software companies.

 

[Paperman]

Re: Future revision of ANVISA RDC 59 - Brazilian GMP

Thank you Marcello,

The document confirms that our products fall in risk class III since they are "products for the typing of blood or tissue to ensure immunological compatibility of blood, blood components, cells, tissues or organs that intended for transfusion or transplantation", as described in Article 6 Rule 2.
Does the group classification, as described in Administrative Order n. 8/MS/SVS, of January 23, 1996, still apply, and if so, what is it used for?

Second question: "Board_Resolution_RDC_nr61_18 november_2011" refers to an Annex to "RDC No. 206 of November 17, 2006". I got a Google translate version of this RDC from the Emergo website but this one does not contain an annex. It refers to "RESOLUTION - RDC No 27, OF JUNE 21, 2011" is the annex in this one THE annex?

Kind regards.

Roeland Kees.

 

[Marcelo]

Re: IVDs classification in Brazil and Anvisa Guidance

It´s curious your timing on those subjects...Anvisa just launched a guidance document titled “Manual for regularization of diagnostic in vitro products” (only in portuguese). Might help you better understand all the requirements.

Regarding your first question, Administrative Order n. 8/MS/SVS is not in effect anymore, RDC 206 revoked it.

Regarding your second question, RDC 206has a big annex which details the requirements for IVDs. Not sure what you got, but I would take care of information you get in English from the net, I´ve seen a lot of times missing stuff or purely wrong info.

You can find a full compendium (at least until May 2011) of medical devices regulations from Anvisa, obviously in portuguese, in the following link: Compêndio da Legislação Sanitária de Dispositivos Médicos

 

[Paperman]

Re: IVDs classification in Brazil and Anvisa Guidance

Thank you for your response Marcelo.

It´s curious your timing on those subjects...

That's because I AM curious, at least that's what people tell me (amongst other things, curious being one of the better ones)

Regarding your first question, Administrative Order n. 8/MS/SVS is not in effect anymore, RDC 206 revoked it.

And out of my files it goes.

Sadly enough the documents in your link are in Portuguese and as such not readable for me.

... I would take care of information you get in English from the net, I´ve seen a lot of times missing stuff or purely wrong info.

That's what I'm always afraid of. However there are very few alternatives. I am hesitant to use Google translate documentation but even a lion will eat grass when there's nothing else. I find it strange that every country that issues all kinds of regulatory demands concerning user information for safe use be issued in the native language or English at least, but they themselves find it acceptable that their information is not in English, understandably for non native speakers. It's a problem I have found in most countries. Practicing what they preach is not their strongest point.


Kind regards.

 

[Linda Liu]

Re: IVDs classification in Brazil and Anvisa Guidance

Dear Marc,

I am Linda from Autobio Diagnostics, I have some questions about IVD registration in Brazil, I have read the Classification in Brazil and Manual of registration process for IVD in brazil document recommended by you already, and for medical device, class I, class II, class III and class IV are classified, and reagentes para imunohematologia (sistema ABO, sistema Rh e anticorpos irregulares), Hepatites B e C, S?filis, HIV, Chagas e HTLV. S?o produtos que pertencem ? classe IV. Then HIV, HBV, HCV and HTLV belong to class IV, while for IVDs in Brazil, there is a special classification, class I, class II, class III and class IIIa (IVD registration process regulation Brazil), class IIIa is self-test, so what about HIV, HBV HCV and HTLV, belong to class III or any other classification?
In addition, tumor markers, Torch should belong to class III according to the classification in Brazil, so whether they belong to the same classification with HBV, HCV, HIV and HTLV?
I really confused with the IVD classification in Brazil.
Looking forward to your reply, thank you very much.

Linda Liu

 

[Marcelo]

Re: IVDs classification in Brazil and Anvisa Guidance

Hello Linda

The old classification which included Class IIIa is not valid anymore, now we only have classes I, II, III and IV.

So HIV, HBV, HCV and HTLV are class IV, according to Rule 1.

Tumor markers are class III, according to Rule 4.

 

[Linda Liu]

Re: IVDs classification in Brazil and Anvisa Guidance

Dear Marc,

Thank you very much for your reply.
Then it's clear to know the class of tumor markers, while for thyroid like TSH, T3 and fertility like LH, FSH, whether they all belong to class II, I am waiting for your confirmation.
Looking forward to your reply, thank you very much.

 

[Marcelo]

Linda, please take a look at the attached RDC 61 with examples, they might make it more clear for you.

As I mentioned before, tumor markers (Marcadores tumorais) are class III according to rule 4.

For the others you mentioned, there?s a need to evaluate more clearly depending on the use, for example, hormones are generally Class II rule 7, and fertility, class II rule 5. But it really depends on a better study of the devices.

 

[spectra123]

Re: IVDs classification in Brazil and Anvisa Guidance

Hi ,
Does anyone have a English translation of the IVD guidance document and RDC No. 206 of November 17, 2006?

Thanks,
TS