Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

[Marcelo Antunes]

Sorry for the confusion. I was actually asking the test report valid period for initial assessment of INMETRO Certification. I

Oh, ok. Well, there´s really nothing about this that I know right now. There´s some talking in the past about going back but the possible options were not accepted. So no, I don´t think that the old requirement will come back now.

[ak_nz]

I apologise for asking another question in this thread but it seems an appropriate place:

We are looking at certifying our medical device into Brazil. The focus of my question is around the electrical safety testing (based on 60601-1 3ed) required for production testing. I am lead to believe that certification for Brazil requires that type-testing performed on the unit is to be repeated in production for every unit.

Is this the case? Is there any guidance or further detail on what is required? I have spoken with our local notified body UL about this and there appears to be confusion there too.

Thanks for any help.

[Marcelo Antunes]

Hello ak_nz and welcome to the Cove!

I apologise for asking another question in this thread but it seems an appropriate place:

We are looking at certifying our medical device into Brazil. The focus of my question is around the electrical safety testing (based on 60601-1 3ed) required for production testing. I am lead to believe that certification for Brazil requires that type-testing performed on the unit is to be repeated in production for every unit.

Is this the case? Is there any guidance or further detail on what is required? I have spoken with our local notified body UL about this and there appears to be confusion there too.

Thanks for any help.

The Brazilian certification requires routine testing (not type testing)) of 100 % of the production process. The tests are - earth bonding, leakage currents, dielectric strength and funcional (output) testing.

The official info is on Annex A of Inmetro Ordinance 350.

[ak_nz]

In Reply to Parent Post by Marcelo Antunes

Hello ak_nz and welcome to the Cove!



The Brazilian certification requires routine testing (not type testing)) of 100 % of the production process. The tests are - earth bonding, leakage currents, dielectric strength and funcional (output) testing.

Thank you for your response Marcelo! From my examination of how this testing is performed, I had a couple further questions regarding the tests themselves. The reason for this questions is more along how other companies handle the increased burden of this test requirement:

- The dielectric strength test refers to both protectively earthed metal parts (our device has a few) and the insulating enclosure (if applicable, our device has an insulating enclosure) since both are providing a means of protection. I would assume that both get tested. Any thoughts around how one would choose which parts of the insulated enclosure would be tested? Or is the onus on the manufacturer to determine the worst case based on their knowledge of the production process?

- The enclosure leakage ("touch current") test specifies the use of a 10x20cm foil test surface for the non-protectively earthed parts and then moving over the surface to determine the highest leakage. I imagine this would be difficult to perform as it is written in the standard for every unit. Any thoughts as to how this would be practically achieved?

Thanks for your reply. Determining both our requirements and how we practically test them for every unit in production is proving to be challenging!

[Marcelo Antunes]

- The dielectric strength test refers to both protectively earthed metal parts (our device has a few) and the insulating enclosure (if applicable, our device has an insulating enclosure) since both are providing a means of protection. I would assume that both get tested. Any thoughts around how one would choose which parts of the insulated enclosure would be tested? Or is the onus on the manufacturer to determine the worst case based on their knowledge of the production process?


- The enclosure leakage ("touch current") test specifies the use of a 10x20cm foil test surface for the non-protectively earthed parts and then moving over the surface to determine the highest leakage. I imagine this would be difficult to perform as it is written in the standard for every unit. Any thoughts as to how this would be practically achieved?

The tests are to be performed exactly as the type tests of your device.

Anyway, for an insulated enclosure, if it´s a big enclosure you may need to test different parts of it with the metal foil. If there´s more than one insulated part, you need to test them all.

In the case of leakage current, during type testing the highest leakage point had to be determined, so you could use only that point for routine testing.

[Marcelo Antunes]

On a curious side note to this topic, both UL and Bureau Veritas (which are certification bodies for a lot of products in Brazil, including medical electrical equipment) had all their scope suspended this week, meaning they can´t perform accredited certification processes.

For those in need to verify if their services return, you can check

http://www.inmetro.gov.br/organismos...denciamento=29

http://www.inmetro.gov.br/organismos...denciamento=18

Look at: Situação (Suspenso) which means Situation (Suspended) in portuguese.

[Sidney Vianna]

I heard through the grapevine that ANVISA got upset with some stakeholders involved in the Medical Device product certification sector in Brazil, after a surgical table broke in the middle of a surgery. Failure analysis led to a series of investigations which uncovered some serious flaws in the process....

[Marcelo Antunes]

I heard through the grapevine that ANVISA got upset with some stakeholders involved in the Medical Device product certification sector in Brazil, after a surgical table broke in the middle of a surgery. Failure analysis led to a series of investigations which uncovered some serious flaws in the process....