IVD risk class II devices for Brazil and MDSAP

#1
Good morning/afternoon,

I’m new to selling IVDs in Brazil and am trying to get some clarification on a couple of points.

None of the devices are higher than a Risk Class II. I understand this means they only require notification rather than registration and would not require an audit from ANVISA or BGMP certification. Does this mean that Brazil does not need to be included in the scope of an MDSAP audit?

The RDC I’m focusing on are RDC 36/2015, 270/2019, 340/202 and 423/2020. Hopefully, these are the most relevant to IVDs?

Thanks in advance for any help. I’ll update this if I manage to get to the bottom of this.
 
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