Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

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....

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....

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Marcelo Antunes said:

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.

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Hello Marcelo,

I'm new to this invaluable forum and I had been following this discussion closely as it applies to our own situation with products that are marketed worldwide and hence the need to accommodate national deviations in a worldwide environment, with regards to Brazil:

We understand that Brazil requires routine testing (100%) of earth bonding, leakage currents, dielectric strength and functional (output) testing as per Annex A of the Inmetro Ordinance 350

However, we are not clear if the requirements of ABNT NBR IEC 60601-1:1994 + Amendment 1:1997 ALSO apply to equipment that comes to a service center for rutine repairs or if it solely applies to new equipment as part of production line testing.


Could you kindly help us understand this dilemma?

Thanks a lot in advance.

Geo-Ans said:

Hello Marcelo,

I'm new to this invaluable forum and I had been following this discussion closely as it applies to our own situation with products that are marketed worldwide and hence the need to accommodate national deviations in a worldwide environment, with regards to Brazil:

We understand that Brazil requires routine testing (100%) of earth bonding, leakage currents, dielectric strength and functional (output) testing as per Annex A of the Inmetro Ordinance 350

However, we are not clear if the requirements of ABNT NBR IEC 60601-1:1994 + Amendment 1:1997 ALSO apply to equipment that comes to a service center for rutine repairs or if it solely applies to new equipment as part of production line testing.


Could you kindly help us understand this dilemma?

Thanks a lot in advance.

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Could someone help us answer this please?

Thanks

Hello Geo-Ans

Sorry, I missed your post.

The requirements for ordinance 350 are only for newly-manufactured devices, the ones that are the output of your production process.

Hi Marcelo,

In TECHNICAL NOTE No. 02/2012/GQUIP/GGTPS/ANVISA (posted March 8, 2012) it seems to suggest that electrical medical equipment does not need INMETRO certification even. Is that true? It's written a bit confusingly. Can you shed some light of what it is saying?

Thanks,
Par Lindh

Is there anybody hear that INMETRO is changing the rule that no longer accept the foreign manufactory to hold the INMETRO certificates? it has to be under the Brazilian company. we are in the final step to be approved by INMETRO and just be noticed that we have to find some local company to help us like ANIVISA certificates.

Just double check in here to get the final confirmation. Thanks!

Kevin

In TECHNICAL NOTE No. 02/2012/GQUIP/GGTPS/ANVISA (posted March 8, 2012) it seems to suggest that electrical medical equipment does not need INMETRO certification even. Is that true? It's written a bit confusingly. Can you shed some light of what it is saying?

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This technical note was created to make it clear that electrical medical devices (in the case, IVD and other laboratory equipment) that are not medical electrical equipment under 60601 were not to perform required mandatory certification.

It also excludes some devices such as hearing aids and active implants from the mandatory certification.

Hi,

Have a question related to ANVISA and third edition.

Do we have to have ANVISA registration application in before 1 Jan 2014 or completed before 1 Jan 2014 if we have a medical device which meets 2nd edition IEC60601-1 standard (and do not wish to move to 3rd edition 60601-1)?

Thnks

Do we have to have ANVISA registration application in before 1 Jan 2014 or completed before 1 Jan 2014 if we have a medical device which meets 2nd edition IEC60601-1 standard (and do not wish to move to 3rd edition 60601-1)?

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Nothing really clear about that (as always), but IN 03 says that third edition should be accepted in certification processes until Jan 2014.

Seems to mean that you could submit ANVISA docs with a certification performed under 2nd edition after JAN 2014.

However, this is not the intent. The intent is that, after 2014, any cadastro/registration be performed under 3rd edition.

Following this line, you would have to submit the cadastro/registry documentation (including the 2nd edition certification) before the end of 2014.