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Medical Equipment Inmetro Certification Process in Brazil - Part 1

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Marcelo Antunes

Addicted to standards
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#41
Re: Medical Equipment Inmetro Certification Process in Brazil

Hi Marcelo,
I do not fully understand what "3rd party accredited", "1st party accredited", etc. means under Brazilian regulation. Would you mind clarifying further?

Suppose I am a medical device manufacturer. Our lab is not ILAC member accredited but we are accredited by a certification agency under the CB scheme. Which one are we?
Hi

1st party - manufacturer's own lab.

3rd party - independent test lab.

Your lab would be a 1st party lab. It's not acceptable for Inmetro certification to be accredited by CB-Scheme. You need to be ILAC, EA or IAAC-traceable (we're discussing the CB-Scheme at the moment but this is something for the future).
 
#42
Re: Medical Equipment Inmetro Certification Process in Brazil

Hi Marcelo,

We are going to prepare to renew our INMETRO certificate that will expire next year. Should I need to redo my test base on IEC 60601-1 since I hear that the report cannot be older than 2 years. could your please clarify my mind?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#43
Re: Medical Equipment Inmetro Certification Process in Brazil

We are going to prepare to renew our INMETRO certificate that will expire next year. Should I need to redo my test base on IEC 60601-1 since I hear that the report cannot be older than 2 years. could your please clarify my mind?
The 2 years is only for new certifications. For renewals, report can be 5 years old.
 
R

recruit

#44
Re: Medical Equipment Inmetro Certification Process in Brazil

The 2 years is only for new certifications. For renewals, report can be 5 years old.
Hi, do you have any update information about application of 3rd standard? You said that Inmetro will issue some regulation about it in March.
Can we use 3rd general standard with 2rd particular standard for Inmetro?
I have another question. For ultrasound device, ANVISA reqeust ABNT NBR IEC 60601-2-37:2003 which is 2rd paticular standard. But IEC published 3rd 60601-2-37. Can we currently apply Inmetro Certification with 3rd general standard and 3rd 60601-2-37?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#45
Re: Medical Equipment Inmetro Certification Process in Brazil

Hi, do you have any update information about application of 3rd standard?
INMETRO will finally publish a draft of the revision of Portaria 350 (in the next few days it seems) and ANVISA will also publish a new normative instruction (probably in December).

You said that Inmetro will issue some regulation about it in March.
Can we use 3rd general standard with 2rd particular standard for Inmetro?
There?s no clear guide on this but I would say no. We will proba bly use separate families of standards.

For ultrasound device, ANVISA reqeust ABNT NBR IEC 60601-2-37:2003 which is 2rd paticular standard. But IEC published 3rd 60601-2-37. Can we currently apply Inmetro Certification with 3rd general standard and 3rd 60601-2-37?
You can, and you will probably be certified, however, certifications bodies are doing this in not an official way because until now there?s no definieion of the Brazilian third edition process. So it?s a bit of a risky businees (but I don?t think it will be any problem anyway).
 
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