Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Sourcing from the meeting held on Dec,26th,2013,ANVISA published Normative Instruction No.9,which approves a list of new Techinical Standards that shall be observed for conformity certification.
It specifies the enforcement of IEC 60601-1 3rd version and includes about 30 new kinds of medical devices mandatorily requested Inmetro certificates. The IVD equipments like hematology analyzer and Bio-chemical analyzer are newly covered.This is a big change to the manufacturer of IVD products.
However, I am not clear of the time-frame of this instruction.Is there any transition period for the products that newly requesting certification?
Thanks!

Hello, and welcome to the Cove!

Sourcing from the meeting held on Dec,26th,2013,ANVISA published Normative Instruction No.9,which approves a list of new Techinical Standards that shall be observed for conformity certification.
It specifies the enforcement of IEC 60601-1 3rd version and includes about 30 new kinds of medical devices mandatorily requested Inmetro certificates. The IVD equipments like hematology analyzer and Bio-chemical analyzer are newly covered.This is a big change to the manufacturer of IVD products.
However, I am not clear of the time-frame of this instruction.Is there any transition period for the products that newly requesting certification?
Thanks!

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No, there?s no transition period. However, the need for certification depends on having the capacity in Brazil to perform the tests, and at this time, a lot of the new tests cannot be performed yet.

Hello,Marcelo! Thank you so much for quick response.Regarding this Instruciton, I still have some questions.

1. If one ultrasound system's certificate was issued before 26th,12.2013 with IEC 60601 2nd version ,and we want to submit a new process or alteration process, would ANVISA recognize the certificate valid?

2.The similar quesion on Patient monitor devices as above.Instruction No.9 lists some new Technical Standards like for clinical thermometers and pulse oximeter equipment mostly applied to patient monitors.We have several products involving alteration process with ANVISA.They finished testing,verifying and their Inmetro certificate without these new standards was issued on 27,December,2013. And we have not submitted them to ANVISA yet. Are these certificate valid after No.9 was published?

3.For IVD equipments applying IEC 61010-2-101, if we want to submit them to ANVISA now, it has to be certified and with a Inmetro certificate, right?

4.You said 'the need for certification depends on having the capacity in Brazil to perform the tests, and at this time, a lot of the new tests cannot be performed yet', how do we define a deadline to 100% meet this Instruction?

5.Is there any feedback or analysis from Brazilian's OCP?

6.Would you mind sharing your valuable evaluation on this No.9?

Thanks!

Please note that a lot of your questions depend on some interpretation and knowledge of the history of certification, as IN 09 is not clear on a lot of topics.

1. If one ultrasound system's certificate was issued before 26th,12.2013 with IEC 60601 2nd version ,and we want to submit a new process or alteration process, would ANVISA recognize the certificate valid?

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Before, when? If it is being tested on the 26th, ANVISA will accept, for registro/cadastro, the certificate with the old standards. If not this case, you will need to use the new rule.

2.The similar quesion on Patient monitor devices as above.Instruction No.9 lists some new Technical Standards like for clinical thermometers and pulse oximeter equipment mostly applied to patient monitors.We have several products involving alteration process with ANVISA.They finished testing,verifying and their Inmetro certificate without these new standards was issued on 27,December,2013. And we have not submitted them to ANVISA yet. Are these certificate valid after No.9 was published?

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One initial comment - the certificate being valid (a valid certificate from a certification body) is different than ANVISA accepting it. In this case, ANVISA will probably accept the certificate on old standards because it was "in test". But I would suggest submitting as quickly as possible.

3.For IVD equipments applying IEC 61010-2-101, if we want to submit them to ANVISA now, it has to be certified and with a Inmetro certificate, right?

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I?m 99% sure that there?s no test house that can perform testing to IEC 61010-2-101 (accredited) at this moment, so the certification would not be mandatory, but anyway you would need to have this declared by your OCP.

4.You said 'the need for certification depends on having the capacity in Brazil to perform the tests, and at this time, a lot of the new tests cannot be performed yet', how do we define a deadline to 100% meet this Instruction?

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There?s no way, because it really depends on the implementation of testing by the test houses in Brazil. For example, if tomorrow a test house is accredited for IEC 61010-2-101, the mandatory certification begins in this date too.

5.Is there any feedback or analysis from Brazilian's OCP?

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Not that I know.

6.Would you mind sharing your valuable evaluation on this No.9?

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I?ve performed an evaluation but I will wait for next week to post anything, on the 28th there will be a meeting of the certification committee and we will probably discuss some of the unclear points of the IN.

Hello,Marcelo! Is there any new progress or further information for IN 9? I feel hard to get reachable to further dynamic analysis.
Thank you so much for sharing your evaluation.

My company is looking to enter into Brazil with some ultrasound devices. There is somewhat of a question as to the smartest approach..

As far as I know, ultrasounds are required to have a GMP cert. These inspections are backlogged now into the 3-5 year timespan. There is however a lawsuit that you can participate in and if you win, ANVISA HAS to give you an inspection within 6 months--however getting an attorney involved is costly to do this. But if you don't go this route, you are looking at a very long time span until we can start selling and establishing in the market.

At the same time....it seems as time goes on the regulations loosen. Perhaps in another year it will actually become easier and cheaper to be able to sell over there.

Has anyone's company here gone the lawsuit route in order to speed up the inspection time?

Also, my manager seems to recall seeing somewhere that ultrasounds actually DO NOT require a GMP audit as of recently. Does anyone know of this development?

Thank you!!

Hello,Marcelo! Is there any new progress or further information for IN 9? I feel hard to get reachable to further dynamic analysis.
Thank you so much for sharing your evaluation.

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Sorry, still discussing it, now with the manufacturer?s and importers?s associations, because there?s a lot of confusion!!!

Hello, and welcome to the Cove!

As far as I know, ultrasounds are required to have a GMP cert. These inspections are backlogged now into the 3-5 year timespan. There is however a lawsuit that you can participate in and if you win, ANVISA HAS to give you an inspection within 6 months--however getting an attorney involved is costly to do this. But if you don't go this route, you are looking at a very long time span until we can start selling and establishing in the market.

At the same time....it seems as time goes on the regulations loosen. Perhaps in another year it will actually become easier and cheaper to be able to sell over there.

Has anyone's company here gone the lawsuit route in order to speed up the inspection time?

Also, my manager seems to recall seeing somewhere that ultrasounds actually DO NOT require a GMP audit as of recently. Does anyone know of this development?

Thank you!!

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The problem with the lawsuit route is that you would go to the lawsuit line It?s still quicker than normal route, but it?s something that may take at least one year in some cases.

Right now diagnostic US is under the registro regime (which requires B-GMP certificate) due to IN 02-2011, but from a public consultation last year, there?s an expectancy that this will be removed in the near future, so what I?m usually saying to my clients is that they should wait a little for this development.

Thanks so much Marcelo, this is very good to know. Any word on how long until they could be removed?

Thanks so much Marcelo, this is very good to know. Any word on how long until they could be removed?

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No, but it?s something to solve ANVISA?s problem with the delayed inspections, so it?s not expected that it will take too long.