{"id":1532,"date":"2021-06-17T18:53:59","date_gmt":"2021-06-17T18:53:59","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/politica\/normalizacion-internacional\/"},"modified":"2021-07-12T17:22:46","modified_gmt":"2021-07-12T17:22:46","slug":"international-standardization","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/?lang=es","title":{"rendered":"Normalizaci\u00f3n Internacional"},"content":{"rendered":"\n<p class=\"mb-3\">La <strong>Normalizaci\u00f3n Internacional<\/strong>&nbsp;se refiere al trabajo realizado dentro de las Organizaciones de Desarrollo de Normas (SDO) internacionales para desarrollar y mantener los documentos armonizados a nivel mundial que definen los criterios t\u00e9cnicos en constante evoluci\u00f3n que sustentan el dise\u00f1o, el desempe\u00f1o, la seguridad, la interoperabilidad, la ciberseguridad y la regulaci\u00f3n de los dispositivos m\u00e9dicos. De acuerdo con las directrices de la Organizaci\u00f3n Mundial de la Salud (WHO) y la obligaci\u00f3n legalmente vinculante de la Organizaci\u00f3n Mundial del Comercio (OMC), los reguladores de dispositivos m\u00e9dicos deben utilizar las normas internacionales como base para sus regulaciones t\u00e9cnicas nacionales de dispositivos m\u00e9dicos. Las normas internacionales tambi\u00e9n definen las reglas para la evaluaci\u00f3n de la conformidad, que son los diversos mecanismos mediante los cuales la industria puede demostrar el cumplimiento de las normas.<\/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-92b0487f 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-50c5de87\"><a target=\"_self\" aria-label=\"Normalizaci\u00f3n y Evaluaci\u00f3n de la Conformidad\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/international-standardization\/normalizacion-y-evaluacion-de-la-conformidad\/?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\">Normalizaci\u00f3n y Evaluaci\u00f3n de la Conformidad<\/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-177097b8\"><a target=\"_self\" aria-label=\"Organizaciones de Desarrollo de Normas, Comit\u00e9s y Normas para Tecnolog\u00eda M\u00e9dica\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/international-standardization\/organismos-nacionales-de-estandarizacion-de-las-americas\/?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\">Organizaciones de Desarrollo de Normas, Comit\u00e9s y Normas para Tecnolog\u00eda M\u00e9dica<\/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-9854b24f\"><a target=\"_self\" aria-label=\"Uso de Normas Internacionales por Reguladores de Dispositivos M\u00e9dicos\" rel=\"noopener noreferrer\" href=\"\/regulatory-convergence\/policy\/international-standardization\/uso-de-estandares-internacionales-por-los-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\">Uso de Normas Internacionales por Reguladores de Dispositivos M\u00e9dicos<\/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: #fff;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button {background: 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