In 2020, Brazil’s National Institute of Metrology, Standardization and Industrial Quality (INMETRO) published a new ordinance, INMETRO Ordinance No. 384/2020, outlining requirements for conformity assessment of medical devices. The new rules will be enforced as of December 28, 2023.

Download our new Fact Sheet outlining the changes in the new ordinance and ensure your medical devices are compliant with the new requirements for Brazil.