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

What is INMETRO? The National Institute of Metrology, Standardization and Industrial Quality, known as INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia), is Brazil’s federal authority responsible for implementing national policies on measurement, standards, and product conformity, operating under the Ministry of Economy. It serves as the executive secretariat to CONMETRO, the national council that sets technical and regulatory norms. What does INMETRO do? INMETRO oversees conformity assessment in Brazil by accrediting calibration and testing laboratories, as well as certification bodies responsible for product approval. It develops and enforces technical regulations and supports certification programs to enhance product safety, measurement accuracy, and quality. Among the regulated categories are electrical and electronic goods, household appliances, automotive parts, toys, and medical devices, each requiring conformity assessment before entering the Brazilian market. What is INMETRO’s role in medical device regulation? 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. Certificates are valid for five years and require periodic renewal or surveillance to remain valid.