Medical Equipment Inmetro Certification Process in Brazil - Part 1

[recruit]

Re: Medical Equipment Inmetro Certification Process in Brazil

Thanks Marcelo.
I have another question about applicant (Item 4.21). Company authorized(Item 4.4), importer (Item 4.10) and overseas Manufacturer(Item 4.8). We are overseas manufacturer and have a branch in office. But our products are registered via a consulting company who is nominal importer since our branch has no ANVISA permission for registration yet. Since the applicant must be Brazilian company, can we use our branch? Must the applicant for Inmetro certificate be same with one for ANVISA registration? For our situation, what is your recommendation?

 

[recruit]

Re: Medical Equipment Inmetro Certification Process in Brazil

I have another question about modification. Portaria 350 request that Certificate mention software version and version of user manual. If we want to revise the software or user manual with tiny changes, such as spelling mistake, is it necessary to re-issue new certificate after certification body finishes evaluation? I personally won't update certificate because presenting to ANVISA any new certificate accompany with official review fee and long alteration process. Especially for tiny changes of user manual. How do you think?

 

[Marcelo]

Re: Medical Equipment Inmetro Certification Process in Brazil

Thanks Marcelo.
I have another question about applicant (Item 4.21). Company authorized(Item 4.4), importer (Item 4.10) and overseas Manufacturer(Item 4.8). We are overseas manufacturer and have a branch in office. But our products are registered via a consulting company who is nominal importer since our branch has no ANVISA permission for registration yet. Since the applicant must be Brazilian company, can we use our branch? Must the applicant for Inmetro certificate be same with one for ANVISA registration? For our situation, what is your recommendation?

Hello Recruit.

Sorry for the late answer, but i was talking to some people regarding the applicant. We in fact changed one requirement, the applicant now does not need to be a Brazilian company. This was decided today, at the meeting of the Certification Committee. So it does not need to be the registration holder.

You could use your branch office or even perform the certification from abroad.

 

[Marcelo]

Re: Medical Equipment Inmetro Certification Process in Brazil

I have another question about modification. Portaria 350 request that Certificate mention software version and version of user manual. If we want to revise the software or user manual with tiny changes, such as spelling mistake, is it necessary to re-issue new certificate after certification body finishes evaluation? I personally won't update certificate because presenting to ANVISA any new certificate accompany with official review fee and long alteration process. Especially for tiny changes of user manual. How do you think?

It´s not totally clear on the regulation, for for changes which do not affect the quality and tests of the product in the manual and software, you do not need a new certification. You would need to forward this to your certification body anyway.

 

[recruit]

Re: Medical Equipment Inmetro Certification Process in Brazil

Hello Recruit.

Sorry for the late answer, but i was talking to some people regarding the applicant. We in fact changed one requirement, the applicant now does not need to be a Brazilian company. This was decided today, at the meeting of the Certification Committee. So it does not need to be the registration holder.

You could use your branch office or even perform the certification from abroad.

Thanks Marcelo.
I wonder when INMETRO will publish the decision. Our certified body said that the decision didn't published, and so continued asking us to change the holder into one Brasilia company holding ANVISA registration. It's very ridiculous.

 

[Marcelo]

Re: Medical Equipment Inmetro Certification Process in Brazil

Thanks Marcelo.
I wonder when INMETRO will publish the decision. Our certified body said that the decision didn't published, and so continued asking us to change the holder into one Brasilia company holding ANVISA registration. It's very ridiculous.

This was decided at the certification commitee meeting, so it won´t be "published by INMETRO" (i still need to create the meeting report, i´m late on that ). Anyway, IF your certification body participated in the meeting (the majority do not) they know they can apply this rule. For the other ones, sorry, you will have a lot of trouble.



You know, this kind of behaviour keeps pissing me off because the certification bodies always try to make obstacles to the process. My clients keep telling me that they think the worst part of the Brazilian RA are the certification bodies, they think CBs are even more problematic than ANVISA (which surely might say something).

(marketing)That´s why i´m creating my own certification body in Brazil focused on medical devices certification. I surely hope to give an expert, reliable and businness focused option to all these CBs (Certification Barriers? ) (/marketing)

 

[Marcelo]

Re: Medical Equipment Inmetro Certification Process in Brazil

I´ve posted this in another thread - (EDIT: Sorry - Link didn't make it through the 2018 migration) but i think we need it here too as it pertains to the devices which require certification.

An interesting update: IN 07 (the list of exceptions to the cadastre regime) has been reviewed and published as IN 02/2011 (attached).

They removed a lot of devices (for example, the ones which needs certification) so this means that these devices now require only cadastre, not registration (the ones IN the list still requires registration).

This means that, for these devices, the B-GMP certificate is not required anymore.

Good news for a lot of manufacturers.

 

[recruit]

Re: Medical Equipment Inmetro Certification Process in Brazil

Hi Marcelo, ANVISA published RDC 27 repealed RDC 32/2007 and In 3/2011 repealed In 8/2009 on June 21, 2011. Do you summary modifications comparing old regulations? By the way, do you have official document that indicate the applicant of certificates can be overseas manufacturers?

 

[recruit]

Re: Medical Equipment Inmetro Certification Process in Brazil

This was decided at the certification commitee meeting, so it won´t be "published by INMETRO" (i still need to create the meeting report, i´m late on that ). Anyway, IF your certification body participated in the meeting (the majority do not) they know they can apply this rule. For the other ones, sorry, you will have a lot of trouble.



You know, this kind of behaviour keeps pissing me off because the certification bodies always try to make obstacles to the process. My clients keep telling me that they think the worst part of the Brazilian RA are the certification bodies, they think CBs are even more problematic than ANVISA (which surely might say something).

(marketing)That´s why i´m creating my own certification body in Brazil focused on medical devices certification. I surely hope to give an expert, reliable and businness focused option to all these CBs (Certification Barriers? ) (/marketing)

Hi Marcelo, did you finalize the meeting report? If so, can you share it with us? We are contacting several certified bodies. Someone agree with us. Another said that applicant must be Bralian companies if no published regulation correct the Portatia 350. But you said that no amended regulation would be published and just had internal meeting report. How can we do?

 

[gmagal]

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?