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Medical Equipment Inmetro Certification Process in Brazil - Part 1

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recruit

#11
Re: Medical Equipment Inmetro Certification Process in Brazil

Hello Recruit

I do not know any consultant in Argentina. The medical devices regulations in Argentina are somewaht likely the Brazilian regulations (in fact they are Mercosur regulations) but they are less burdensome (although there´s some parts which are more difficult...for example, Argentina has been requiring for some time conformance with the third edition of IEC 60601 :-().
Thanks Marcelo. then could you talk about compliance with third iec60601-1 third version? It should be useful for us.
 

Paramedic

Involved In Discussions
#12
Re: Medical Equipment Inmetro Certification Process in Brazil

I have analyzed Portaria 350/10 and a lot of questions came up. Maybe someone can help me answering below questions and/or comment my assumptions – they may be also good issues to be discussed in this thread (the numbers at the beginning are the referred sections of Portaria 350/10):


n 4.4. licensed company
„The licensed company is the manufacturer or the importer of the product.”
è only the Brazilian importer/distributor or we (the manufacturer) or both ? - Taking into consideration items 7 (complaint handling), 8.3 (Traceability) and 10 (especially technical and penal responsibility), I assume that only the Brazilian importer/distributor can be the licensed company.

n 6.1.1.1 Application for init. Assessm.
- which exact technical documentation has to be submitted ?
- what happens first: initial audit or initial type test ? à Taking into consideration item 6.1.1.4, I assume that the initial audit happens first, because 6.1.1.4 states that after the assessment of 6.1.1.2 (solicitation) the audit must be scheduled. (And the type test by recognition of test reports can happen subsequently).

n 6.1.1.3 Initial type test
- „After launched production line the OCP must validate these product(s)”
è prototypes which have already been tested must be validated by the OCP after launched production line à which validations/tests must be performed in this case ? Routine tests acc. to Annex A or further technical documentation or both ?

n 6.1.1.3.1.3 / 6.1.1.3.1.3.1 (initial type test)
Are there meant only the changes which have an impact on the conformity ?

n 6.1.1.5 Issuing of Conformity Certificate
- analyzing item 6.1.1.5.5.1, OEM– and supplier-manufacturing sites must be audited as well. Can these points also be audited at the PLM (legal manufacturer) e.g. by document review (supplier contracts etc.) ?

n 9.4. Suspensão, cancelamento ou renovação da autorização
“…. happens if none of the requirements of this RAC is met..” ßàwhat exactly is meant by this phrase ?: none or not all ?

n 9.4.4 states that for the recertification the type tests must be done again if:
- Age of (IEC-) report used for initial type test/conformity- assessment ≥ 5 years
à even if the applicable standards have not been revised/changed ?

OR

- Standard(s) applied for initial type test changed / revised
è even if the change/revision of the standards does not impact the “initial conformity” ?

OR

- Change which has an impact of the type‘s previously assessed conformity
è even if according to item 6.1.2.2.1.4 it has been decided during a maintenance assessment that in despite of the impact on the conformity there were no new type tests necessary?

n 10.1 p)
Does the conformity mark has to be printed in the commercial presentation (catalog etc. ?) or what does 10.1 p) mean ?

n 14. „ENCERRAMENTO DO PROCESSO DE CERTIFICAÇÃO“
What may be the reason for the “ENCERRAMENTO DO PROCESSO DE CERTIFICAÇÃO” / what is the intention of section 14 ?

n If the documentation which has to be submitted for the solicitation and during the audit is not available in Portuguese/English: how does this affect the success of the certification ?

:confused:
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#13
Re: Medical Equipment Inmetro Certification Process in Brazil

Thanks Marcelo. then could you talk about compliance with third iec60601-1 third version? It should be useful for us.
Wow, just missed this. Well, the fact is Argentina requires electrical safety testing to IEC standards, and at the moment they are already requiring tests in the new version of the IEC 60601 standards.

A general overview of the registration process in Argentina can be seen, in spanish, in the following link: http://www.anmat.gov.ar/webanmat/tecmed/productos/92121.asp
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#14
Re: Medical Equipment Inmetro Certification Process in Brazil

4.4. licensed company
„The licensed company is the manufacturer or the importer of the product.”
è only the Brazilian importer/distributor or we (the manufacturer) or both ? - Taking into consideration items 7 (complaint handling), 8.3 (Traceability) and 10 (especially technical and penal responsibility), I assume that only the Brazilian importer/distributor can be the licensed company.
Only Brazilian entities.

n 6.1.1.1 Application for init. Assessm.
- which exact technical documentation has to be submitted ?
- what happens first: initial audit or initial type test ? à Taking into consideration item 6.1.1.4, I assume that the initial audit happens first, because 6.1.1.4 states that after the assessment of 6.1.1.2 (solicitation) the audit must be scheduled. (And the type test by recognition of test reports can happen subsequently).
The generic and formal process is that the audit is first (besides what you mentioned, there´s also a need for the OCP to get a sample). But this process is not always followed. For example, sometimes the tests are being performed long before the initical contact with the OCP.

Each OCP requires specific documentation, but generally they are related to technical information about the product, maybe some test reports if they are already done, and certificates if any.

- „After launched production line the OCP must validate these product(s)”
è prototypes which have already been tested must be validated by the OCP after launched production line à which validations/tests must be performed in this case ? Routine tests acc. to Annex A or further technical documentation or both ?
Both. The idea is the OCP have top be sure that the prototype reflects the final device. It´might even be possible that some additional type testing is needed.

6.1.1.3.1.3 / 6.1.1.3.1.3.1 (initial type test)
Are there meant only the changes which have an impact on the conformity ?
In principle yes, but in fact changes in general are being sctrutinizing at the moment due to a requirement by Anvisa (this new portaria was made more complex and with a lot of additional requirements because of problems rtelated to design changes). Another problem is there´s no guidance at the moment detailing what are changes that need to be taken into account. I´m chairing a study group to develop a guidance document on significat changes related to Portaria 350, we hope to have an initial draft soon.


n 6.1.1.5 Issuing of Conformity Certificate
- analyzing item 6.1.1.5.5.1, OEM– and supplier-manufacturing sites must be audited as well. Can these points also be audited at the PLM (legal manufacturer) e.g. by document review (supplier contracts etc.) ?
No, this is the same problem as with the Anvisa GMP inspections...the audit must be performed at the manufacturing site, if it´s a third party, then it must be done there.

9.4. Suspensão, cancelamento ou renovação da autorização
“…. happens if none of the requirements of this RAC is met..” ßàwhat exactly is meant by this phrase ?: none or not all ?
Not all. In the original, it´s "any".

9.4.4 states that for the recertification the type tests must be done again if:
- Age of (IEC-) report used for initial type test/conformity- assessment ≥ 5 years
à even if the applicable standards have not been revised/changed ?
- Standard(s) applied for initial type test changed / revised
è even if the change/revision of the standards does not impact the “initial conformity” ?

- Change which has an impact of the type‘s previously assessed conformity
è even if according to item 6.1.2.2.1.4 it has been decided during a maintenance assessment that in despite of the impact on the conformity there were no new type tests necessary?

In the case of a recertification, it´s focused on a time-base, so you will need in 5 years to have a new test report anyway. This is as always was, meaning Anvisa was worried that in 5 years there "must" be changes......almost a police state :p....anyway, in a recent meeting of the Certification Committee Anvisa was very open to review timeline requirements (our main worry at the moment is the 2 years test report for initial certification) so there´s might be some change to this in the future.

n 10.1 p)
Does the conformity mark has to be printed in the commercial presentation (catalog etc. ?) or what does 10.1 p) mean ?
In principle only on the device, but there´s an Inmetro regulation wich details control of their conformity marking.

14. „ENCERRAMENTO DO PROCESSO DE CERTIFICAÇÃO“
What may be the reason for the “ENCERRAMENTO DO PROCESSO DE CERTIFICAÇÃO” / what is the intention of section 14 ?
When you stop manufacturing a technology/device.

If the documentation which has to be submitted for the solicitation and during the audit is not available in Portuguese/English: how does this affect the success of the certification ?
Greatly. At least english is a must.
 

Paramedic

Involved In Discussions
#15
Re: Medical Equipment Inmetro Certification Process in Brazil

In principle yes, but in fact changes in general are being sctrutinizing at the moment due to a requirement by Anvisa (this new portaria was made more complex and with a lot of additional requirements because of problems rtelated to design changes). Another problem is there´s no guidance at the moment detailing what are changes that need to be taken into account. I´m chairing a study group to develop a guidance document on significat changes related to Portaria 350, we hope to have an initial draft soon.
Marcelo, first I wanna thank you very much for your replies.
Regarding above considered changes:
Would it be a thinkable way to follow FDA guidance(s) to decide which changes have to be taken into account ?
 

Paramedic

Involved In Discussions
#16
Re: Medical Equipment Inmetro Certification Process in Brazil

Only Brazilian entities.

In the case of a recertification, it´s focused on a time-base, so you will need in 5 years to have a new test report anyway. This is as always was, meaning Anvisa was worried that in 5 years there "must" be changes......almost a police state :p....anyway, in a recent meeting of the Certification Committee Anvisa was very open to review timeline requirements (our main worry at the moment is the 2 years test report for initial certification) so there´s might be some change to this in the future.
I lately heard that Brazilian companies protest against Port. 350/10, because they say that this Portaria is not sustainable (which is also my opinion). --> Can there be expected some major changes other than the "2-year-issue" ?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#18
Re: Medical Equipment Inmetro Certification Process in Brazil

Would it be a thinkable way to follow FDA guidance(s) to decide which changes have to be taken into account ?
I would say that the MDD guidance (NB-MED/2.5.2) would be a better guidance to use. At least that´s what i´m mainly using to draft the brazilian guidance document.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#19
Re: Medical Equipment Inmetro Certification Process in Brazil

I lately heard that Brazilian companies protest against Port. 350/10, because they say that this Portaria is not sustainable (which is also my opinion). --> Can there be expected some major changes other than the "2-year-issue" ?
As i participate in different ways both brazilian medical devices associations (importers and manufacturers) i did hear some crying but only in specific points.

For example, the major criticism of importers (which i at the moment represent thru ABIMED is related to the 2-year initial certification. The main convern of the manufacturers is related to the concept of medical electrical equipment "families".

In general, Portaria 350 is a very good regulation (i´m suspect to say so because i´m one of the authors) which as always was changed without noticed regarding some specific requirements..and those are the problematic ones :)
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#20
Re: Medical Equipment Inmetro Certification Process in Brazil

Do you mean INMETRO - Portaria nº 179/2009 ?
Yes, but portaria 179 is the general one. NIE-CGCRE-009
Uso da Marca, do Símbolo e de Referências à Acreditação is the specific one with additional requirements for certification bodies.
 
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