{"id":1780,"date":"2021-06-18T13:04:43","date_gmt":"2021-06-18T13:04:43","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/politica\/convergencia-regulatoria-del-sector-de-dispositivos-medicos\/"},"modified":"2021-07-12T17:40:16","modified_gmt":"2021-07-12T17:40:16","slug":"medical-device-sector-regulatory-convergence","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/?lang=es","title":{"rendered":"Convergencia Regulatoria del Sector de Dispositivos M\u00e9dicos"},"content":{"rendered":"\n<p>La <strong>Convergencia Regulatoria del Sector de Dispositivos M\u00e9dicos<\/strong> es un esfuerzo p\u00fablico-privado concertado para buscar y maximizar sistem\u00e1ticamente la alineaci\u00f3n de las regulaciones t\u00e9cnicas, normas y criterios de evaluaci\u00f3n de la conformidad espec\u00edficos del sector de dispositivos m\u00e9dicos con las normas mundiales armonizadas internacionalmente.<\/p>\n\n\n\n<p>Seg\u00fan la OMS, m\u00e1s de dos millones de tipos diferentes de dispositivos m\u00e9dicos circulan en el mercado mundial, categorizados en m\u00e1s de 22,000 grupos de dispositivos gen\u00e9ricos. La regulaci\u00f3n de los dispositivos m\u00e9dicos contribuye a la reducci\u00f3n de los riesgos potenciales derivados de su uso y permite a la poblaci\u00f3n acceder a dispositivos m\u00e9dicos seguros, efectivos y de alta calidad, contribuyendo a mejores resultados en salud p\u00fablica.<\/p>\n\n\n\n<p class=\"mb-3\">Sobre el control de estos productos, es importante implementar un enfoque alineado mundialmente que, al mismo tiempo, contribuya al acceso de productos seguros y no impida la innovaci\u00f3n ni cree barreras innecesarias al comercio.<\/p>\n\n\n\n<p>En esta secci\u00f3n encontrar\u00e1s informaci\u00f3n \u00fatil sobre los siguientes temas:<\/p>\n\n\n\n<div class=\"wp-block-uagb-icon-list uagb-icon-list__outer-wrap uagb-icon-list__layout-vertical uagb-icon-list__icon-at-top uagb-block-b8834de2 mb-3\"><div class=\"uagb-icon-list__wrap\">\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-186a4b73\"><a target=\"_self\" aria-label=\"Documentos de la Organizaci\u00f3n Mundial de la Salud\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/documentos-de-la-organizacion-mundial-de-la-salud\/?lang=es\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Documentos de la Organizaci\u00f3n Mundial de la Salud<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-1cc56960\"><a target=\"_self\" aria-label=\"Foro Internacional de Reguladores de Dispositivos M\u00e9dicos\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/foro-internacional-de-reguladores-de-dispositivos-medicos\/?lang=es\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Foro Internacional de Reguladores de Dispositivos M\u00e9dicos<\/span><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-icon-list-child uagb-icon-list-repeater uagb-icon-list__wrapper uagb-block-1673074a\"><a target=\"_self\" aria-label=\"Programa de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos (MDSAP)\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/programa-de-auditoria-unica-de-dispositivos-medicos-mdsap\/?lang=es\"><\/a><div class=\"uagb-icon-list__content-wrap\"><span class=\"uagb-icon-list__source-wrap\"><span class=\"uagb-icon-list__source-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg><\/span><\/span><div class=\"uagb-icon-list__label-wrap\"><span class=\"uagb-icon-list__label\">Programa de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos (MDSAP)<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i {color: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i:hover {color: 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max-width: 12.5%; } } @media (min-width: 1200px) { .wpcpro-row .wpcpro-col-xl-1 { flex: 0 0 100%; max-width: 100%; } .wpcpro-row .wpcpro-col-xl-2 { flex: 0 0 50%; max-width: 50%; } .wpcpro-row .wpcpro-col-xl-3 { flex: 0 0 33.22222222%; max-width: 33.22222222%; } .wpcpro-row .wpcpro-col-xl-4 { flex: 0 0 25%; max-width: 25%; } .wpcpro-row .wpcpro-col-xl-5 { flex: 0 0 20%; max-width: 20%; } .wpcpro-row .wpcpro-col-xl-6 { flex: 0 0 16.66667%; max-width: 16.66667%; } .wpcpro-row .wpcpro-col-xl-7 { flex: 0 0 14.28571428%; max-width: 14.28571428%; } .wpcpro-row .wpcpro-col-xl-8 { flex: 0 0 12.5%; max-width: 12.5%; } }<\/style><div class=\"wpcp-carousel-wrapper wpcp-wrapper-118\">\n\t<div id=\"wpcp-preloader-118\" class=\"wpcp-carousel-preloader\"><img decoding=\"async\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/plugins\/wp-carousel-free\/public\/css\/spinner.svg\" alt=\"Preloader Image\" \/><\/div>\t<div 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