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anvisa, brazil, cadastre process (simplified registration), electrical equipment, inmetro certification process, medical device electronics and electrical equipment, medical device registration, medical devices (general)
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  #9  
Old 5th March 2012, 11:25 AM
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Quote:
Hi,

I am a new member and have a question concerning ANVISA Classification and INMETRO certification. I have been given contradictory advice regarding the classification of pregnancy tests. The tests are digital - i.e. they have a digital presentation of the result. I have been advised that these are Class IIIa IVDs and no INMETRO certification is required. On the other hand, I have also been advised that these are electro-medical (Rule 10, Class II) Medical Devices and INMETRO certification is required. We claim compliance with IEC 61010, for lab equipment, not 60101, and are hoping that we do not need to have the devices tested to 60101 for INMETRO certification.

I would really value you opinion on this situation.

Many thanks, HammyH
Hello HammyH and welcome to the Cove!

If they are MEE - Medical electrical equipment as defined by IEC 60601 - then Inmetro certification is required (please note that this is totally separate from the Anvisa classification scheme)

If they are any other kind ofelectrical medical device, then at the moment Inmetro certificatio is not required.

IN your case, as you already mentioned, they are possible considered lab equipment under 61010. IEC 61010 certification is not required at the moment, but will in the near future (we are finishing the internalization process of the third edition of the standard and Anvisa will begin requiring certification to IEC 61010 afterwards).

Also, some certification bodies do not know this (or they know, which is worse) and might be trying fo force you to do something which you don't need to.

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  #10  
Old 6th March 2012, 07:18 AM
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Hi Marcelo,

Thanks for the welcome and for the information you have provided. We consider that the devices are not medical electrical equipment as defined by IEC 60601 and therefore INMETRO certification will not be required.

You say that IEC 61010 certification will be required soon. Do you know when this might be? We are currently in the process of registering products for sale in Brazil. We submitted GMP inspection requests to ANVISA in July 2011, so it is possible that the GMP inspections will take place towards the end of 2012. We would then like to make our regulatory submissions. Should we be ensuring that we have valid IEC 61010 test reports for the products now in case certification is required when we make our regulatory submissions to ANVISA, hopefully early in 2013?

Many thanks,
HammyH
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  #11  
Old 6th March 2012, 06:13 PM
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Marcelo Antunes Marcelo Antunes is offline
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Quote:
You say that IEC 61010 certification will be required soon. Do you know when this might be? We are currently in the process of registering products for sale in Brazil. We submitted GMP inspection requests to ANVISA in July 2011, so it is possible that the GMP inspections will take place towards the end of 2012. We would then like to make our regulatory submissions. Should we be ensuring that we have valid IEC 61010 test reports for the products now in case certification is required when we make our regulatory submissions to ANVISA, hopefully early in 2013?
This will problably take at least a while. Our Brazilian verison of the standard will be published between July and September of this year. It's equivalent to the new, 2010, 3Ed version of IEC 61010. In fact, this standard is not yet used, at least in a regulatory way, worldwide.

Anvisa is aware of this and will "very likely" implement a transition period for the certification. The group I chair (our IEC TC 66 Brazilian mirror), which is responsible for IEC 61010 in Brazil, will problably propose a transition plan to make sure that we do have a certification, but not rushed in a way that wil impact negatively all stakeholders.

Regarding the certification, it will be equal to the certification of MEE, becuase the idea is simply to add our Brazilian version of IEC 61010 in the list of compulsory standards, meaning a compulsory certification under RDC 27 wil be required.

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Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  #12  
Old 7th March 2012, 09:45 AM
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Hi Marcelo,

Thanks again for the information and the background to the planned implementation of certification to IEC 61010.

I guess what we need to do is make sure that we are ready for when this time comes and we have test reports to the latest version of IEC 61010 (3rd edition) that have been issued from an ILAC accredited test lab (we will use a UKAS lab in the UK).

Will the IEC 61010 certification process be similar to the IEC 60601 Inmetro certification process, which is handled by CBs accredited by Inmetro, or will it just be done through Anvisa?

Many thanks,
HammyH
  #13  
Old 8th March 2012, 06:48 AM
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Marcelo Antunes Marcelo Antunes is offline
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Quote:
Will the IEC 61010 certification process be similar to the IEC 60601 Inmetro certification process, which is handled by CBs accredited by Inmetro, or will it just be done through Anvisa?
It will be the same scheme as the IEC 60601 one, even under the same regulation.

Anyway, Anvisa is beginning a process of designating CBs and Labs for working under Anvisa requirements. Those will need to be accreduted by Inmetro and also designated by Anvisa.

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Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  #14  
Old 22nd March 2012, 02:22 PM
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Hi Marcelo,

I would be very grateful for your thoughts on medical devices which have been on-market in Brazil for a number of years already, i.e. pre-dating many of the current regulations regarding GMP etc (e.g. pre-dating RDC N 16, OF APRIL, 23, 2009).

Might there be any requirement for ANVISA GMP certification to continue marketing these products when there is a change of some sort - for example a change of distributor - or is it sufficient that the products remain INMETRO certified?

Many thanks,

R'gbot
  #15  
Old 22nd March 2012, 07:22 PM
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Marcelo Antunes Marcelo Antunes is offline
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Hi

Quote:
I would be very grateful for your thoughts on medical devices which have been on-market in Brazil for a number of years already, i.e. pre-dating many of the current regulations regarding GMP etc (e.g. pre-dating RDC N 16, OF APRIL, 23, 2009).

Might there be any requirement for ANVISA GMP certification to continue marketing these products when there is a change of some sort - for example a change of distributor - or is it sufficient that the products remain INMETRO certified?
RDC N 16, OF APRIL, 23, 2009 only deals with the maintainability of the B-GMP, not sure what you meant with this mention.


The GMP , as usual for quality systems, has a change control requirement, which means you need to control the changes to your devices. Depending on what you change, you need to ask for Anvisa permission first.

This is also true to the Inmetro certification, you also need to ask permission of your certification body first.

If you change the distributor of a critical component, you may need to provide evidence that your evaluation of the new distributor concludes that the change has no impact because the new distributor can provide you with the requirements you need...or something like that.

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  #16  
Old 23rd March 2012, 07:57 AM
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Re: Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Hi Marcelo,

Thank you for the explanation re impact of product changes, very much appreciated.

In the situation where, for instance, a device has been on the market in Brazil for e.g. 10 - 20 years already and there are no changes to the device itself, is there a requirement for the manufacturer to register for ANVISA GMP certification - i.e. is this requirement now retroactive?

Many thanks,

R'gbot
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