{"id":1472,"date":"2021-06-17T17:33:59","date_gmt":"2021-06-17T17:33:59","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/la-coalicion\/terminos-de-referencia\/"},"modified":"2021-07-08T18:59:44","modified_gmt":"2021-07-08T18:59:44","slug":"terms-of-reference","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/about\/terms-of-reference\/?lang=es","title":{"rendered":"T\u00e9rminos de Referencia"},"content":{"rendered":"\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"181\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/header_about_ethics.png\" alt=\"\" class=\"wp-image-158\" srcset=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/header_about_ethics.png 1024w, https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/header_about_ethics-300x53.png 300w, https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/header_about_ethics-768x136.png 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<h2 class=\"has-normal-font-size wp-block-heading\"><strong>Visi\u00f3n<\/strong><\/h2>\n\n\n\n<p>La Visi\u00f3n de la Coalici\u00f3n Interamericana para la Convergencia Regulatoria para el Sector de Tecnolog\u00eda M\u00e9dica (\u201cla Coalici\u00f3n\u201d) es una norma, una prueba, aceptada en todas partes para cualquier \u00e1mbito de tecnolog\u00eda m\u00e9dica. Esta visi\u00f3n implica que los reguladores de tecnolog\u00eda m\u00e9dica en todo el hemisferio occidental basen sus regulaciones, normas y criterios para la evaluaci\u00f3n de la conformidad nacionales de dispositivos m\u00e9dicos en las normas internacionales relevantes para la tecnolog\u00eda m\u00e9dica.<\/p>\n\n\n\n<h2 class=\"has-normal-font-size wp-block-heading\"><strong>Misi\u00f3n<\/strong><\/h2>\n\n\n\n<p>La Misi\u00f3n de la Coalici\u00f3n es liderar la coordinaci\u00f3n de todas las partes interesadas materialmente afectadas para lograr esta Visi\u00f3n. Esto incluye promover la cooperaci\u00f3n regulatoria en todo el hemisferio occidental para lograr regulaciones, normas y requisitos para la evaluaci\u00f3n de la conformidad de tecnolog\u00eda m\u00e9dica alineados internacionalmente dentro de un proceso continuo de convergencia para maximizar el acceso de los pacientes a tecnolog\u00edas m\u00e9dicas innovadoras, efectivas, que salvan y mejoran vidas&nbsp;<sup>(1)<\/sup>.\r\n\r\n<\/p>\n\n\n\n<h2 class=\"has-normal-font-size wp-block-heading\"><strong>T\u00e9rminos de Gobernanza<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Los &#8220;Miembros Principales&#8221; de la Coalici\u00f3n incluyen asociaciones industriales relacionadas con el sector de la tecnolog\u00eda m\u00e9dica con sede en el hemisferio occidental.\r\n<\/li><li>La Coalici\u00f3n tambi\u00e9n da la bienvenida a las partes de normalizaci\u00f3n para que act\u00faen como `&#8221;Miembros de Normalizaci\u00f3n&#8221; que se definen como: (1) cualquier Organizaci\u00f3n de desarrollo de normas (SDO), organismo nacional miembro de ISO, IEC u otra SDO, u otra organizaci\u00f3n o comit\u00e9 t\u00e9cnico de la misma que participe en o se dedique a la normalizaci\u00f3n internacional de dispositivos m\u00e9dicos; (2) cualquier organizaci\u00f3n que participe en actividades relacionadas con la evaluaci\u00f3n de la conformidad de dispositivos m\u00e9dicos, incluida la normalizaci\u00f3n internacional de los criterios para la evaluaci\u00f3n de la conformidad de dispositivos m\u00e9dicos. Las condiciones para ser miembro de la Coalici\u00f3n para estas entidades son: (A) estar de acuerdo con la Visi\u00f3n, Misi\u00f3n y objetivos de la Coalici\u00f3n; (B) aprobaci\u00f3n de los miembros principales.\r\n<\/li><li>La Coalici\u00f3n da la bienvenida como &#8220;Observadores&#8221; a todas las partes interesadas afectadas, como autoridades gubernamentales y reguladoras, profesionales y organizaciones sanitarias, que pueden apoyar la Misi\u00f3n de la Coalici\u00f3n.<\/li><li>La Coalici\u00f3n tendr\u00e1: (a) un Comit\u00e9 Ejecutivo, compuesto por siete representantes de los &#8220;Miembros Principales&#8221; que se reunir\u00e1n peri\u00f3dicamente para promover el Plan de Acci\u00f3n de la Coalici\u00f3n, as\u00ed como para prepararse para las reuniones de la Coalici\u00f3n y compromisos externos, (b) un Secretario Ejecutivo y Secretariado T\u00e9cnico responsable de coordinar, asistir y ejecutar el trabajo de la Coalici\u00f3n seg\u00fan lo aconsejado por el Comit\u00e9 Ejecutivo. AdvaMed, ALDIMED y ALADDIV tendr\u00e1n un puesto permanente en el Comit\u00e9 Ejecutivo respectivamente, con cuatro puestos abiertos para la elecci\u00f3n de los miembros de la Coalici\u00f3n cada dos a\u00f1os. Cada uno de estos cuatro puestos debe representar a un pa\u00eds diferente. AdvaMed financiar\u00e1 al Secretariado T\u00e9cnico y administrar\u00e1 al Secretariado Ejecutivo, considerando la orientaci\u00f3n y la gu\u00eda del Comit\u00e9 Ejecutivo y los miembros de la Coalici\u00f3n.<\/li><li>El Comit\u00e9 Ejecutivo analizar\u00e1 y aprobar\u00e1 con voto por mayor\u00eda plena, los documentos propuestos por el Secretariado T\u00e9cnico para luego ser circulados a los Miembros Titulares, para su votaci\u00f3n seg\u00fan el proceso establecido en este documento.<\/li><li>Los miembros principales de la Coalici\u00f3n se reunir\u00e1n al menos dos veces por a\u00f1o calendario, con al menos una reuni\u00f3n presencial. La reuni\u00f3n puede ser convocada en cualquier pa\u00eds miembro de la Coalici\u00f3n.<\/li><li>La Coalici\u00f3n establecer\u00e1 un proceso acordado para permitir que los miembros principales y los miembros de normalizaci\u00f3n se unan y mantengan su buena reputaci\u00f3n una vez que se hayan unido.<\/li><li>La Coalici\u00f3n establecer\u00e1 un proceso para revisar, adoptar y\/o enmendar documentos de la Coalici\u00f3n nuevos o existentes, incluido el Plan de Acci\u00f3n, los T\u00e9rminos de Referencia y los recursos relevantes, entre otros. El Comit\u00e9 Ejecutivo revisar\u00e1 y proporcionar\u00e1 aportes sobre todos los documentos antes de que se distribuyan a los Miembros Principales. Una vez distribuidos, los miembros de la Coalici\u00f3n tendr\u00e1n un m\u00ednimo de treinta d\u00edas para hacer comentarios. Los miembros de la coalici\u00f3n pueden aprobar documentos finales por mayor\u00eda de votos. La Coalici\u00f3n deber\u00e1 esforzarse por lograr consenso; los miembros que no est\u00e9n de acuerdo con el resultado de una votaci\u00f3n deber\u00e1n tomar medidas correctivas con el Comit\u00e9 Ejecutivo. El Plan de Acci\u00f3n de la Coalici\u00f3n deber\u00e1 someterse a una revisi\u00f3n peri\u00f3dica cada dos a\u00f1os.<\/li><li>La Coalici\u00f3n y sus miembros cumplen con los&nbsp;<a href=\"\/ethics\/the-bogota-principles\/?lang=es\">Principios de Bogot\u00e1<\/a>.<\/li><\/ul>\n\n\n\n<p class=\"mt-3 mb-3\"><sup>(1)<\/sup> \u201dMedical Technologies\u201d incluye dispositivos m\u00e9dicos, productos de diagn\u00f3stico, tecnolog\u00edas de salud digital y se define formalmente en <a href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/MD-Definition-Website.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">GHTF\/SG1\/N071:2012<\/a> y como se les sigue haciendo referencia en los \u00faltimos documentos de la IMDRF.<\/p>\n\n\n\n<p>Puede descargar este documento en los enlaces siguientes:<\/p>\n\n\n\n<p><a href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/terms-of-reference-en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English: Terms of Reference<\/a><\/p>\n\n\n\n<p class=\"mb-3\"><a href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/terms-of-reference-es.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Espa\u00f1ol: T\u00e9rminos de Referencia<\/a><\/p>\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 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