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.).
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 (unlike the 50 Hz standard in Europe and many other regions). Devices designed for 50 Hz markets must be re-validated to confirm safe operation at 60 Hz, including verification of motor speeds, heating element performance, and electromagnetic compatibility with Brazilian electrical infrastructure.
Verify all information against official ANVISA sources before making regulatory decisions.
The applicable INMETRO compulsory certification list is published in INMETRO Portarias and is regularly updated. Check the current INMETRO website or contact ANVISA's technical department to confirm whether your specific device category requires dual INMETRO certification. Common categories requiring dual certification include surgical lights, patient monitors, and infusion pumps.