INMETRO (National Institute of Metrology, Standardization and Industrial Quality)

INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia) is Brazil’s federal agency that makes sure products meet national standards for safety, quality, and accuracy. It does this by setting technical rules and accrediting laboratories and certification bodies that test and approve products. Any product in certain regulated categories must go through INMETRO’s conformity assessment process before it can be sold in Brazil. These categories include electrical and electronic equipment, household appliances, automotive parts, toys, and medical devices. By requiring certification and proper labeling, INMETRO helps ensure that products on the Brazilian market are safe, reliable, and consistent with national standards.

INMETRO certification is a prerequisite for registering electrical and certain non-electrical medical devices with ANVISA. For example, electromedical devices subject to IEC 60601 standards must secure INMETRO approval, including testing by an accredited laboratory and a factory inspection, before applying for ANVISA registration. The certification process is governed by Ordinance 384:2020 and reinforced by RDC No. 549/2021, which establish the scope and technical requirements for mandatory INMETRO conformity assessment in electromedical equipment.

Website: INMETRO