Electrical Safety & EMC
For active (electrically powered) medical devices, Brazil adopts the IEC 60601 series through ABNT (ABNT NBR IEC 60601-1, -1-2, etc.).
BR-unique
Some active medical devices require INMETRO certification in addition to ANVISA registration. Check the INMETRO compulsory certification portaria before finalising your regulatory strategy.
Brazil uses 60 Hz mains frequency (not 50 Hz as in Europe). Devices designed for 50 Hz markets must be verified for Brazilian electrical infrastructure.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.