Autores: Frederico de Lima, Rodrigo P.B. Costa-Felix, Rodrigo Ozanan Oliveira

Abstract: The Regulatory Impact Analysis-RIA demonstrates significant advances in the regulatory format in Brazil. The new regulatory model for health equipment or medical devices established in Inmetro Ordinance No. 384 of December 2020 is a positive example in RIA practice. However, there are signs of the need for improvement when regulatory institutions share regulation responsibility. The present paper discloses the impact analysis regarding Inmetro ordinance 384 (Medical Electrical Equipment).

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