Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Marcelo Antunes

Addicted to standards
Staff member
Admin
Hi Marcelo,
I have read the translated regulations and could not find anything that addresses my specific question so I hope you can provide some guidance. I am in process of obtaining INMETRO certification and a question has come up in regards to language requirements.

The regulations make it very clear that the IFU must be in Portuguese. What is not clear to me is if a medical device has an electronic display that provides information to the user if that information is required to be in Portuguese. The display provides information such as various controls, testing, various preset programs, treatment times, power output parameters etc.

Thanks,
Glenn
There's no formal requirement in the regulations to translate an electronic display. However, ANVISA expects that the IFU does provide enough information in Portuguese about what is displayed to enable safe and effective use of the device.

The following text is from an ANVISA guide:

"For products that have software in a foreign language, the IFU shall have detailed information about each control screen and control bar, written in Portuguese, to allow the user to a proper and safe use of the equipment. The same applies to the functions of the controls, commands and operating indicators used in the equipment.
 
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Marcelo Antunes

Addicted to standards
Staff member
Admin
There's no formal requirement in the regulations to translated an electronic display. However, ANVISA expects that the IFU does provide enough information in Portuguese about what is displayed to enable safe and effective use of the device.

The following text is from an ANVISA guide:

"For products that have software in a foreign language, the IFU shall have detailed information about each control screen and control bar, written in Portuguese, to allow the user to a proper and safe use of the equipment. The same applies to the functions of the controls, commands and operating indicators used in the equipment.
Also, putting information in Portuguese in the IFU is ok for professional use. For lay use, ANVISA expects that the software interface is entirely translated into Portuguese.
 

tibon74

Involved In Discussions
Hi guys,

Is it possible to transfer a license (approval of medical device) from legal manufacturer to another ? if so, how?

Thank you!!
 

tibon74

Involved In Discussions
Thank you Marcelo !
I means, could we change the legal manufacturer from company X to company Y which belong to the same group/company ?

on the other hand, I understood that RDC102/2016 is only applicable for license ownership (BRH) transfer not on legal manufacturers change. it is wrong ?

by the way, do you know transfer fees according to RDC102/2016 ?

thanks again !
 
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Marcelo Antunes

Addicted to standards
Staff member
Admin
I means, could we change the legal manufacturer from company X to company Y which belong to the same group/company ?
on the other hand, I understood that RDC102/2016 is only applicable for license ownership (BRH) transfer not on legal manufacturers change. it is wrong ?

Yes, it's only applicable to registration/cadastre transfer.

by the way, do you know transfer fees according to RDC102/2016 ?
There are no fees.
 

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