Examinando por Autor "Acuña Graciano, Linda Erica"

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    Enfoque regulatorio peruano y de las agencias reguladoras de países de alta vigilancia sanitaria de la Unión Europea y América sobre el uso de dispositivos médicos con di (2-etilhexil) ftalato en la población vulnerable
    (Universidad Privada Norbert Wiener, 2018-09-19) Acuña Graciano, Linda Erica; Salvatierra Guerrero, Sandra Sofia; Llatas Gonzales, Yvonne Magali
    This research presents the regulations, management approaches, and official statements of High Health Surveillance Agencies from the European Union and the Americas regarding the use of medical devices containing DEHP. It also examines the fundamental principles and guidelines of Peruvian health regulation related to this issue. In addition, this work compiles considerations on the role of other specialized institutions that provide scientific support for the development of more appropriate regulatory frameworks. For more than 40 years, health regulation was primarily based on granting marketing authorizations for medical devices without validating their safety or assessing their potential impact on vulnerable populations. The future outlook for Peruvian health regulation should be grounded in reforms to the current regulatory framework, taking as a reference an agile, simple, transparent, and effective model, supported by scientific evidence and modern, reliable technical procedures.