Active Devices & INMETRO Certification
BR-unique
Certain active (electrically powered) medical devices require compulsory INMETRO certification in addition to ANVISA registration — a dual-approval requirement unique to Brazil.
INMETRO certification is required for electrical and electronic medical equipment listed in INMETRO's compulsory certification portaria. Check the current list before finalising your regulatory strategy.
INMETRO certification process: Engage an INMETRO-accredited Certification Body (OCP) → Submit for testing against ABNT NBR IEC 60601 standards → Factory audit (if required) → OCP issues certificate → Apply INMETRO conformity mark.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.