{"id":1654,"date":"2021-06-18T10:45:08","date_gmt":"2021-06-18T10:45:08","guid":{"rendered":"https:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/nivel-2-buenas-practicas-regulatorias-reglamentos-tecnicos-normas-y-evaluacion-de-la-conformidad-en-el-sector-de-los-dispositivos-medicos\/"},"modified":"2021-06-18T14:40:43","modified_gmt":"2021-06-18T14:40:43","slug":"nivel-2","status":"publish","type":"page","link":"https:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/projects\/standards-alliance\/1-0\/nivel-2\/?lang=es","title":{"rendered":"Nivel 2 \u2013 Buenas pr\u00e1cticas regulatorias, reglamentos t\u00e9cnicos, normas y evaluaci\u00f3n de la conformidad en el sector de los dispositivos m\u00e9dicos"},"content":{"rendered":"\n<h2 class=\"has-medium-font-size wp-block-heading\">Fase 1: Creaci\u00f3n de la gu\u00eda de implementaci\u00f3n<\/h2>\n\n\n\n<p class=\"mb-3\">AdvaMed trabaj\u00f3 en estrecha colaboraci\u00f3n con el Foro Internacional de Reguladores de Dispositivos M\u00e9dicos (IMDRF), la Organizaci\u00f3n Panamericana de la Salud (OPS), la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA), la Alianza Latinoamericana de Tecnolog\u00eda M\u00e9dica (ALDIMED) y la Alianza Latinoamericana de Diagn\u00f3stico In Vitro (ALADDIV) para crear una lista de referencia f\u00e1cil de usar de los puntos de referencia internacionales para las regulaciones t\u00e9cnicas de dispositivos m\u00e9dicos, normas y mecanismos de evaluaci\u00f3n de la conformidad. Esta referencia se incluye a continuaci\u00f3n en <a href=\"https:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/nivel-2-documentos-de-referencia-global-marcos-regulatorios-del-sector-de-dispositivos-medicos-bpr-reglamentos-normas-mecanismos-de-evaluacion-de-la-conformidad\/?lang=es\">en Documentos de Referencia Internacional \u2013 Tier 2 (en ingl\u00e9s)<\/a>.<\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Fase 2: Evaluaci\u00f3n y an\u00e1lisis de brechas<\/h2>\n\n\n\n<p>Utilizando la gu\u00eda de referencia sectorial como punto focal, la Alianza por las Normas trabaj\u00f3 con los pa\u00edses participantes para llevar a cabo evaluaciones de las Buenas Pr\u00e1cticas Regulatorias, Reglamentos T\u00e9cnicos, Normas y Evaluaci\u00f3n de la Conformidad existentes para el sector de dispositivos m\u00e9dicos.<\/p>\n\n\n\n<p>El informe de an\u00e1lisis de carencias, que incluye informaci\u00f3n sobre los comit\u00e9s internacionales y nacionales de normalizaci\u00f3n pertinentes, est\u00e1 disponible a trav\u00e9s de los siguientes enlaces:<\/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-b73496eb 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-a90ae448\"><a target=\"_blank\" aria-label=\"Medical Device Regulatory \/ Standards GAP Analysis Report (English)\" rel=\"noopener noreferrer\" href=\"http:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/standard_alliance_tier2_final_report_es.pdf\"><\/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\">Informe de an\u00e1lisis GAP de regulaci\u00f3n \/ normas t\u00e9cnicas<\/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-69e624e6\"><a target=\"_blank\" aria-label=\"Medical Device Regulatory \/ Standards GAP Analysis Report (Portuguese)\" rel=\"noopener noreferrer\" href=\"http:\/\/staging.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/standard_alliance_tier2_final_report_pt.pdf\"><\/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\">Informe de an\u00e1lisis de GAP de normativas \/ normas de dispositivos m\u00e9dicos (Portugu\u00e9s)<\/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-00a447b4\"><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\">Medical Device Regulatory \/ Standards GAP Analysis Report Summary Video (Spanish with English subtitles)<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"Standards Alliance \u2013 Tier 2 Summary Video\" width=\"1200\" height=\"675\" src=\"https:\/\/www.youtube.com\/embed\/YAYh8kBO8tc?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen><\/iframe>\n<\/div><\/figure>\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-9cc90835 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-b1b6d60d\"><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\">Informe de An\u00e1lisis GAP de Regulaci\u00f3n\/ Normas de Dispositivos M\u00e9dicos \u2013 Informaci\u00f3n Suplementaria de SDO<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Fase 3: Cooperaci\u00f3n bilateral<\/h2>\n\n\n\n<p class=\"mb-3\">A partir del desarrollo del an\u00e1lisis de carencias, la Alianza por las Normas inici\u00f3 los trabajos con cada pa\u00eds del proyecto de forma bilateral para comenzar a abordar las brechas identificadas con los puntos de referencia internacionales.<\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Fase 4: Cooperaci\u00f3n Multilateral<\/h2>\n\n\n\n<p class=\"mb-3\">A partir del desarrollo del an\u00e1lisis de carencias, la Alianza por las Normas inici\u00f3 los trabajos con los pa\u00edses del proyecto, de forma multilateral para comenzar a abordar las brechas identificadas con los puntos de referencia internacionales. AdvaMed conect\u00f3 formalmente la Alianza por las Normas con la reuni\u00f3n anual de reguladores de dispositivos m\u00e9dicos de la Organizaci\u00f3n Panamericana de la Salud, compartiendo las mejores pr\u00e1cticas sobre buenas pr\u00e1cticas regulatorias espec\u00edficas de dispositivos m\u00e9dicos, reglamentos t\u00e9cnicos, normas y equipos de implementaci\u00f3n de pol\u00edticas de evaluaci\u00f3n de la conformidad de los pa\u00edses participantes.<\/p>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-38424bce\"><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 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper 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