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 and potentially re-engineered to confirm safe operation at 60 Hz, including verification of: motor speeds and power consumption, heating element thermal performance, transformer and power supply ratings, and electromagnetic compatibility with Brazilian electrical infrastructure. Technical documentation submitted to ANVISA must explicitly address 60 Hz compliance or include a letter from the manufacturer confirming the device was originally designed and validated for 60 Hz operation.
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.
INMETRO Dual Certification Verification: The INMETRO compulsory certification list is organized by product categories (Portarias). Common medical device categories requiring dual ANVISA and INMETRO certification include: patient monitors, surgical lights, electrosurgical units, infusion pumps, defibrillators, and ventilators. Verify applicability by: (1) consulting the current INMETRO website (inmetro.gov.br) for active Portarias, (2) contacting ANVISA's technical department directly, or (3) engaging a local regulatory consultant familiar with current certification requirements. Failing to obtain INMETRO certification for a required device category results in import/sales prohibition and product seizure.