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Marcelo Antunes

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Inmetro recently published, after a lot of delays, the new regulation for medical electrical equipment certification (which now applies to all medical electrical equipment under IEC 60601 and the certificate is a requirement for the petitioning of the registry at Anvisa, which means that the Inmetro certification process has to be finished before petitining the registry). It´s Portaria 350.

I´ve made a presentation (in Prezi, a wonderful presentation tool) which i will give to Abimed (brazilian medical device importers association) members, and translated it into english to help those not familiar with portuguese. It´s attached to this post.
 

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AnnieB

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#2
Re: Medical Equipment Inmetro Certification Process in Brazil

So, we jumped through hoops to get products certified this year, and we'll have to do it all over again before September 2011?
 

Marcelo Antunes

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Re: Medical Equipment Inmetro Certification Process in Brazil

So, we jumped through hoops to get products certified this year, and we'll have to do it all over again before September 2011?
You will need to be in compliance with Portaria 350 until September 2011, but this does not mean you need a new certification. A maintenance audit each year is already required, so you will need to provide evidence in your next audit that you are in compliance with the new regulation. This will usually means your quality system will need to be assessed under the itens from ISo 13485 on annex B (It was ISO 9001 before) or you could use a certificate of ISO 13485 pr B-GMP. This, if you did not change your equipment.
 

recruit

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#4
Re: Medical Equipment Inmetro Certification Process in Brazil

According to Portaria 350, does INMETRO accept test reports issued first lab under iLac?
 

Marcelo Antunes

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Re: Medical Equipment Inmetro Certification Process in Brazil

According to Portaria 350, does INMETRO accept test reports issued first lab under iLac?
This point is the same as Portaria 86.....

The first option is a 3rd party accredited. IN Portaria 350, if there´s no 3rd party accredited or the beginning of tests are to be more than 6 months, you can use options.

a) 3rd accredited to other scope
b) 1st accredited
c) 3rd non-accredited
d) 1st non-accredited

SO in principle yes, you could use the 1st party if you show that the other first two cannot be met. Anyway, you will have to discuss this with your certificatrion body.
 

recruit

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Re: Medical Equipment Inmetro Certification Process in Brazil

This point is the same as Portaria 86.....

The first option is a 3rd party accredited. IN Portaria 350, if there´s no 3rd party accredited or the beginning of tests are to be more than 6 months, you can use options.

a) 3rd accredited to other scope
b) 1st accredited
c) 3rd non-accredited
d) 1st non-accredited

SO in principle yes, you could use the 1st party if you show that the other first two cannot be met. Anyway, you will have to discuss this with your certificatrion body.
So bad news. Thanks Marcelo
 

recruit

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#7
Re: Medical Equipment Inmetro Certification Process in Brazil

This point is the same as Portaria 86.....

The first option is a 3rd party accredited. IN Portaria 350, if there´s no 3rd party accredited or the beginning of tests are to be more than 6 months, you can use options.

a) 3rd accredited to other scope
b) 1st accredited
c) 3rd non-accredited
d) 1st non-accredited

SO in principle yes, you could use the 1st party if you show that the other first two cannot be met. Anyway, you will have to discuss this with your certificatrion body.
Hi Marcelo, I wonder how to define 1st party accredited according to Brazilian regulation. In fact, when our internal safety lab was auditted for accreditation under iLac according to ISO 17025, the CEO signed a declaration that he won't intervene the Independence of the lab. So we think the lab should be regarded 3rd accredited lab. How do you think?
 

Marcelo Antunes

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#8
Re: Medical Equipment Inmetro Certification Process in Brazil

Hi Marcelo, I wonder how to define 1st party accredited according to Brazilian regulation. In fact, when our internal safety lab was auditted for accreditation under iLac according to ISO 17025, the CEO signed a declaration that he won't intervene the Independence of the lab. So we think the lab should be regarded 3rd accredited lab. How do you think?
Third party is defined "a person or body that is independent of the organization or person that provides the object of conformity assessment".

In principle a declaration of independence would be enough to for the definition.

In practice, Inmetro understands that a third party is a separate entity so if your lab is internal even with the declaration it will be considered a third party.

And i think it´s used this way around the world (but i´m not totally sure).

Tip - ask the acreditation body of your lab if they consider your lab first or third party.
 

recruit

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#9
Re: Medical Equipment Inmetro Certification Process in Brazil

Hi Marcelo,
I am looking for a professional consultant for sanitary registration of medical devices in Argentina. Do you have any available resource? Or give me some clues? Thanks
 

Marcelo Antunes

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#10
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 :-().
 
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