INMETRO Conformity Marks — When Required
BR-unique
INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia) is Brazil's national metrology and standards institute. For certain active medical devices, INMETRO's compulsory certification mark is required on the device or its packaging — in addition to ANVISA registration.
INMETRO certification and its conformity mark (Marca de Conformidade INMETRO) are required for:
- Medical electrical equipment listed in INMETRO's compulsory certification portaria;
- Measuring instruments used for legal metrology purposes; and
- Some other product categories periodically added to the compulsory list.
How to determine if your device requires INMETRO certification: Check the current compulsory product list on the INMETRO website against your device's HS/NCM code and device type.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.