Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Thanks Marc.

Dear all ,
my company is currently trying to get access to Brazilian market for some medical electric devices.
The distributor asks for some documents, including the IEC 60601-1 test report.
We contacted our NB, which is accredited under both ILAC and CB scheme , and initially ask for CB testing.
They said that they have two different templates for issuing the reports under the different schemes (or perhaps different procedures) and for Brazil the ILAC test report is required.
The distributor however said that it is enough that the laboratory is accredited by ILAC member: we ask them for checking at the INMETRO labs, but we still have not a conclusive answer by them and we need this info to proceed with the tests.
Does anyone know if the INMETRO certification labs (I think the distributor will use UL Brazil) still accept CB reports even if Brazil is currently suspended by the CB scheme? we would prefer this template for the report because (as far as I know) CB reports are more required than ILAC reports in the rest of the world
Thank in advance for any information

Brazilian regulations have never accepted CB certificates.

The regulations require that test reports from abroad are from test houses accredited by organizations which are part of the ILAC MOU (meaning, they are ILAC-traceable).

If the test house you mentioned has 2 different templates for CB and ILAC, and the CB template is not traceable to the ILAC "accreditation" then you might only use the ILAC one.

But this is weird because usually the CB reports are also under the ILAC "accreditation" (in fact, there's no ILAC template from ILAC, test houses have their own templates that meets requirements from ILAC).

Yes we did INMETRO ceritifcation recently. They only accept ILAC accredited reports. Our test lab is ILAC accredited and also can issue CB reports

Hi everyone!

I am a new one here. I have problem with understanding then GMP requirements. Acc. to RDC 24/2009, medical devices in Class I and II are under a simplified registration (cadastre) and do not require the Anvisa audit. Nonetheless, do we need to comply with the RDC 59/2009?

Thx in adavance.

Hello blackcrow05, and welcome to the Cove!

I have problem with understanding then GMP requirements. Acc. to RDC 24/2009, medical devices in Class I and II are under a simplified registration (cadastre) and do not require the Anvisa audit. Nonetheless, do we need to comply with the RDC 59/2009?

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If your device is under the cadastre process, there's no need to show the GMP "certificate" which is given after an ANVISA audit.

However, RDC 59 (now RDC 16) is a resolution (almost a law) which has to be complied with, regardless of someone going to your factory to audit. So yes, you do have to comply.

Thx for the quick respose. Is it possible to be audited by the ANVISA during the validity of our cadastre if we are out the regular registation process? Does the Anvisa staff practise the documentation control distantly? I mean how does it look like in real??

Is it possible to be audited by the ANVISA during the validity of our cadastre if we are out the regular registation process?

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Unlikely.

Does the Anvisa staff practise the documentation control distantly?

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No they don't.

I think that the only way you might have a problem is if there's an adverse event related to your device and ANVISA goes to the plant and find it being not in compliance with the regulation. Even this case would be rare, thought.

Many thx, Marcelo!

Dear Mr. Antunes:

Hello. I have sent my inquiris to your e-mail last Friday.
We are looking forward to your reply soon.

Kind regards,
Mickey