Medical Device Registration Process in Brazil - Anvisa (Part 2)

[Marcelo]

I would like to know if, during an ANVISA inspection, inspectors could see the technical files (registration files) submitted to ANVISA for the product registrations ?

Yes, they could, although they would best be verifying design documents.

 

[Marcelo]

Our company has moved to a new location and asked the auditor about having a inspection on new manufacturing site. He said that yearly maintenance inspection will be conducted and the certification will be updated once the maintenance inspection is complete. Then, is it ok to send our goods to Brazil with our new address or should we use our old address to send goods until we get yearly maintenance inspection?

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You are talking about INMETRO certification here, right? You problem is really related to ANVISA requirements, not certification requirements.

 

[tibon74]

thank you very much Marcelo !

 

[vitols]

Hi Marcelo,

I like to know if your very useful flowchart about "Medical device registration and cadastre process in Brazil - Anvisa - V.3" (dated 22/07/2011) is still reliable today or, meanwhile, some regulatory changes was made by ANVISA to the Medical Device Registration process.

Regards,
Vitols



elsmar.com/Forums/showpost.php?p=444032&postcount=205

 

[nikolaos]

Hello,

I would like to know if EMC Test should cover both voltages of 100-120V/60Hz and 230V/60Hz for INMETRO certification. A EMC Test Report dated 2009 is still valid the certification or an updated is required?
Thank you

Regards
Nikolaos

 

[Vlcekad]

Hello,

This is the situatation: We have a registration in Brazil (through a local company) fro a product. We (manufacturer) changed our name, but everyting else stays the same.

Any ideas what is the change process with ANVISA? How long this change might take?

I have been told, that this change might not be a big deal for ANVISA itself but rather for custom officers who will notice the discrepancy with ANVISA database and wont release the products.

Thanks for help.
Adam

 

[Marcelo]

Hi Marcelo,

I like to know if your very useful flowchart about "Medical device registration and cadastre process in Brazil - Anvisa - V.3" (dated 22/07/2011) is still reliable today or, meanwhile, some regulatory changes was made by ANVISA to the Medical Device Registration process.

Yes, it is. There where some changes in regulation related, for example, on how the GMp certificate is granted, but this is not included in the flowchart, so it is still valid today.

 

[Marcelo]

I would like to know if EMC Test should cover both voltages of 100-120V/60Hz and 230V/60Hz for INMETRO certification.

Yes because both are used in Brazil.

A EMC Test Report dated 2009 is still valid the certification or an updated is required?

Only for re-certification, not for the initial one (whoich needs to be at most 2 years old).

 

[Marcelo]

This is the situatation: We have a registration in Brazil (through a local company) fro a product. We (manufacturer) changed our name, but everyting else stays the same.

Any ideas what is the change process with ANVISA? How long this change might take?

I have been told, that this change might not be a big deal for ANVISA itself but rather for custom officers who will notice the discrepancy with ANVISA database and wont release the products.

You registration company needs to change the name in the registration. It?s a common change petition to the registration process. Time...depends on the type of device. Formally ANVISA has some 90 days in general to answer to anything, but it always takes more.

 

[nikolaos]

Hello,
If I am not wrong from 01/01/2014 IEC60601-1:2005 (3rd Ed.) is mandatory in Brazil. Our device manufactured in Brazil has a INMETRO Certificate for ABNT NBR IEC 60601-1:1997 valid till 22/01/2015. Does this mean that till that date (22/01/2015) a conformity to IEC60601-1:2005 (3rd Ed.) is not required?

Thank you
Nikolaos