Brazil - Is Medical Software a Medical Device?

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Marcelo

Inactive Registered Visitor
#12
Sorry, I meant CD, DVD or USB, anything physical.

There?s no specific regulation for protection of patient data from ANVISA, but there are general requirements on the essential requirements and GMP for that.
 
T

tmcompl

#14
Hello Marcelo:
In regards to the comment on whether it is necessary for professional use equipment with software interface (imaging equipment such as e.g. Ultrasound, X-ray, CT, PET and MRI), are there any Brazilian (ANVISA/INMETRO) guidelines stating exemption for that Software interface and User Manual in English? or we have to adopt the fact that at least the Software User Manual needs to be in Portuguese?
(Professional as in operation by trained Radiologist)

thanks,
PT

As in the previous post that the general requirement would be that it is in the Portuguese language. However, most of the time the software is too complex and lengthy for that. So manufacturers usually only translate the main windows necessary for safe use.
 

Marcelo

Inactive Registered Visitor
#15
are there any Brazilian (ANVISA/INMETRO) guidelines stating exemption for that Software interface and User Manual in English?
Nope. The requirements re that they are in Portuguese.

or we have to adopt the fact that at least the Software User Manual needs to be in Portuguese?
The user manual has to be in Portuguese, there´s not way out that. What I discussed before it´s better if the main windows are in Portuguese too.

(Professional as in operation by trained Radiologist)
Thre´s no requirement in Brazil that a trained Radiologist knows English (and most probably don´t) so this is really not a good justification.
 
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