{"id":1744,"date":"2021-06-18T12:20:03","date_gmt":"2021-06-18T12:20:03","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/accion-de-la-coalicion\/posiciones-por-pais\/chile\/"},"modified":"2023-04-27T22:34:19","modified_gmt":"2023-04-27T22:34:19","slug":"chile","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/coalition-action\/posiciones-por-pais\/chile\/?lang=es","title":{"rendered":"Chile"},"content":{"rendered":"\n<div class=\"wp-block-uagb-info-box mb-1 uagb-infobox__outer-wrap uagb-block-b356390a\"><div class=\"uagb-infobox__content-wrap uagb-infobox uagb-infobox-has-image uagb-infobox-icon-left uagb-infobox-left uagb-infobox-stacked-tablet uagb-infobox-image-valign-middle uagb-infobox-enable-border-radius \"><div class=\"uagb-ifb-left-right-wrap\"><div class=\"uagb-ifb-image-icon-content uagb-ifb-imgicon-wrap\"><div class=\"uagb-ifb-image\"><div class=\"uagb-ifb-image-content\"><img decoding=\"async\" class=\"uagb-ifb-img-src\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/flag_chile.jpg\" alt=\"\"\/><\/div><\/div><\/div><div class=\"uagb-ifb-content\"><div class=\"uagb-ifb-title-wrap\"><h3 class=\"uagb-ifb-title\">NOTIFICACI\u00d3N WTO\/TBT G\/TBT\/N\/CHL\/536 DEL 9 DE OCTUBRE 2020 \u2013 BORRADOR DE LEY CHILENA QUE MODIFICA EL C\u00d3DIGO SANITARIO<\/h3><\/div><div class=\"uagb-ifb-text-wrap\"><\/div><\/div><\/div><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading line-height-1-5\" style=\"font-size:18px\"><strong>BORRADOR DE LEY CHILENA QUE MODIFICA EL C\u00d3DIGO SANITARIO<\/strong><\/h2>\n\n\n\n<p class=\"justified\">Como parte de los esfuerzos de colaboraci\u00f3n para influenciar el desarrollo y mejora de regulaciones t\u00e9cnicas para dispositivos m\u00e9dicos, la Coalici\u00f3n prepar\u00f3, en colaboraci\u00f3n con AdvaMed, ADIMECH y APIS, un posicionamiento sobre el impacto potencial de la implementaci\u00f3n de los cambios propuestos en el Borrador de Ley.<\/p>\n\n\n\n<p class=\"justified\">Ante la aprobaci\u00f3n inminente de una versi\u00f3n actualizaca de la ley mencionada en el p\u00e1rrafo anterior, la Agencia Nacional de Dispositivos M\u00e9dicos, Innovaci\u00f3n y Desarrollo (ANDID) requiere desarrollar la regulaci\u00f3n para operacionalizarla.<\/p>\n\n\n\n<p class=\"justified mb-3\">La Coalici\u00f3n, dentro de su trabajo continuo para apoyar a los reguladores de la regi\u00f3n en sus esfuerzos de convergencia, prepar\u00f3 un Posicionamiento sobre Buenas Pr\u00e1cticas Regulatorias, incluyendo las Obligaciones Comerciales y las Referencia en Salud m\u00e1s relevantes, para asistir a la ANDID en este proceso. El texto completo de este documento est\u00e1 disponible <a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2022\/03\/IACRC-Posicionamiento-Regulacio\u0301n-Chilena-Final.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">aqu\u00ed<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading line-height-1-5\" style=\"font-size:18px\"><strong>BORRADOR DE DECRETO CHILENO QUE SOMETE AL CONTROL DE LOS DISPOSITIVOS M\u00c9DICOS DISPUESTO EN EL ART\u00cdCULO 111\u00b0 DEL C\u00d3DIGO SANITARIO, A LOS \u201cREACTIVOS INMUNOHEMATOL\u00d3GICOS\u201d<\/strong><\/h2>\n\n\n\n<p class=\"justified\">Notificaci\u00f3n a la Organizaci\u00f3n Mundial de Comercio G\/TBT\/N\/CHL\/624 \u201cPropuesta de Decreto que somete al control de los dispositivos m\u00e9dicos dispuesto en el art\u00edculo 111\u00ba del C\u00f3digo Sanitario, a los &#8220;reactivos inmunohematol\u00f3gicos&#8221;\u201d.<\/p>\n\n\n\n<p class=\"justified mb-3\">Como parte de los esfuerzos de colaboraci\u00f3n para influenciar el desarrollo y mejora de regulaciones t\u00e9cnicas para dispositivos m\u00e9dicos, la Coalici\u00f3n prepar\u00f3, en colaboraci\u00f3n con los Miembros de la Coalici\u00f3n, un posicionamiento sobre el impacto potencial de la implementaci\u00f3n de los cambios propuestos en el Borrador de Decreto. El texto completo de este documento est\u00e1 disponible <a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/04\/Posicionamiento-IACRC-Reactivos-Inmunohematologicos-Abril-2023-Final-20Apr23-.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">aqu\u00ed<\/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 .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 .wpcpro-row{align-items: center;}#sp-wp-carousel-free-id-118 .wpcp-single-item {box-shadow: 0px 0px 0px 0px #dddddd;transition: all .3s;margin: 0px;}#sp-wp-carousel-free-id-118.swiper-flip .wpcp-single-item{margin: 0!important;}#sp-wp-carousel-free-id-118 .wpcp-single-item:hover {box-shadow: 0px 0px 0px 0px #dddddd;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-single-item {border: 0px solid transparent;}#sp-wp-carousel-free-id-118.sp-wpcp-118 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