{"id":1713,"date":"2021-06-18T11:51:55","date_gmt":"2021-06-18T11:51:55","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/modelo-global-de-marco-regulatorio-de-la-oms-para-dispositivos-medicos-incluyendo-dispositivos-medicos-para-diagnostico-in-vitro\/"},"modified":"2021-09-14T11:33:30","modified_gmt":"2021-09-14T11:33:30","slug":"orientacion-oms","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/documentos-de-la-organizacion-mundial-de-la-salud\/orientacion-oms\/?lang=es","title":{"rendered":"Modelo Global de Marco Regulatorio de la OMS para Dispositivos M\u00e9dicos, incluyendo dispositivos m\u00e9dicos para diagn\u00f3stico in vitro"},"content":{"rendered":"\n<section class=\"wp-block-uagb-columns uagb-columns__wrap uagb-columns__background-undefined uagb-columns__stack-mobile uagb-columns__valign-undefined uagb-columns__gap-0 alignundefined uagb-block-0d17a572\"><div class=\"uagb-columns__overlay\"><\/div><div class=\"uagb-columns__inner-wrap uagb-columns__columns-2\">\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-78ab7012\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"205\" height=\"265\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/09\/who_model_1_1_es.jpg\" alt=\"\" class=\"wp-image-2799\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-eeeda844\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<p class=\"mb-3\">El modelo sugiere un enfoque progresivo, estableciendo dos niveles de control a adoptar: b\u00e1sico y ampliado. El uso de estos niveles de control depender\u00e1 de la madurez del sistema regulatorio existente en el pa\u00eds. Tambi\u00e9n sugiere que los pa\u00edses utilicen mecanismos de confianza (un proceso en el que una autoridad reguladora considera la evaluaci\u00f3n realizada por otra autoridad en su proceso de toma de decisiones).<\/p>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/09\/WHO_Global_Model_Regulatory_Framework_for_Medical_Devices_including_in_v.._Espanol-13Sep21-edits-22Reliance22.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">LEER EL DOCUMENTO<\/a><\/div>\n<\/div>\n\n\n\n<p class=\"mb-3\">Traducci\u00f3n libre realizada por la Coalici\u00f3n<\/p>\n<\/div><\/div>\n<\/div><\/section>\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: #1e1e1e;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button:hover {background: #1e1e1e;}#sp-wp-carousel-free-id-118 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper .swiper-slide-kenburn, .wpcp-wrapper-118 .swiper-wrapper, .wpcp-wrapper-118 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alt=\"member_amid\" width=\"240\" height=\"98\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_advamed.jpg\" alt=\"member_advamed\" width=\"240\" height=\"65\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<div class=\"wpcp-swiper-dots swiper-pagination\"><\/div>\n\t\t\t\t<!-- If we need navigation buttons -->\n\t\t\t\t\t<div class=\"wpcp-prev-button swiper-button-prev\"><i class=\"fa fa-angle-left\"><\/i><\/div>\n\t\t\t<div class=\"wpcp-next-button swiper-button-next\"><i class=\"fa fa-angle-right\"><\/i><\/div>\n\t\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>El modelo sugiere un enfoque progresivo, estableciendo dos niveles de control a adoptar: b\u00e1sico y ampliado. El uso de estos niveles de control depender\u00e1 de la madurez del sistema regulatorio existente en el pa\u00eds. Tambi\u00e9n sugiere que los pa\u00edses utilicen mecanismos de confianza (un proceso en el que una autoridad reguladora considera la evaluaci\u00f3n realizada&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2245,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-1713","page","type-page","status-publish","hentry","description-off"],"acf":[],"featured_image_src":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Modelo Global de Marco Regulatorio de la OMS para Dispositivos M\u00e9dicos, incluyendo dispositivos m\u00e9dicos para diagn\u00f3stico in vitro - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/documentos-de-la-organizacion-mundial-de-la-salud\/orientacion-oms\/?lang=es\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Modelo Global de Marco Regulatorio de la OMS para Dispositivos M\u00e9dicos, incluyendo dispositivos m\u00e9dicos para diagn\u00f3stico in vitro - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"El modelo sugiere un enfoque progresivo, estableciendo dos niveles de control a adoptar: b\u00e1sico y ampliado. El uso de estos niveles de control depender\u00e1 de la madurez del sistema regulatorio existente en el pa\u00eds. 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