INMETRO Conformity Marks — When Required
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.
Verify all information against official ANVISA sources before making regulatory decisions.
INMETRO certification requires submission to a notified body accredited by INMETRO. The certification process includes technical file review, laboratory testing (if required), and issuance of a conformity certificate. Timeline varies by device complexity and notified body workload, typically 4–12 weeks. Once certified, the INMETRO Marca de Conformidade (conformity mark) must appear on the device or packaging alongside the ANVISA registration number. Both ANVISA and INMETRO authorisations must be in place before marketing. Check INMETRO's current portaria regularly, as compulsory certification requirements are updated periodically.