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Tue, Jul 15, 2025

Latin America

Home » Topics » Regions » Latin America
  • Regulatory icons
    May 7, 2024
    By Mark McCarty

    Mexico’s COFEPRIS adds SaMD to definitions in revised labeling rule

    Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.
  • Brazil flag
    Jan. 25, 2023
    By Sergio Held

    Brazil’s new medical device rules starting in March promise to simplify process

    Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
  • Aug. 30, 2022
    By Mari Serebrov

    Proxalutamide study once again in Brazilian crosshairs

    Brazilian regulatory agency Anvisa reported that it is participating in an investigation that launched Aug. 25 into alleged crimes of smuggling, misrepresenting, distributing and delivering proxalutamide related to a clinical trial in Brazil.
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