{"id":24297,"date":"2025-12-19T08:01:46","date_gmt":"2025-12-19T11:01:46","guid":{"rendered":"https:\/\/sobelconsult.com\/fda-publishes-q3e-for-extractables-leachables\/"},"modified":"2026-10-24T06:40:00","modified_gmt":"2026-10-24T09:40:00","slug":"fda-publishes-q3e-for-extractables-leachables","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/es\/fda-publishes-q3e-for-extractables-leachables\/","title":{"rendered":"Noticias: La FDA publica el Q3E de Extra\u00edbles y Lixiviables"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">La FDA ha publicado una <strong>nueva directriz alineada con la ICH Q3E para apoyar la evaluaci\u00f3n de los Extra\u00edbles y Lixiviables (E&amp;L), <\/strong>junto con documentaci\u00f3n de apoyo que incluye monograf\u00edas para los llamados lixiviables de Clase 3.<\/p>\n\n<p class=\"wp-block-paragraph\">El documento refuerza un enfoque basado en el riesgo, es decir,<strong>aumenta las expectativas en torno a<\/strong>:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>la solidez de los estudios anal\u00edticos,<\/li>\n\n\n\n<li>el establecimiento de l\u00edmites de exposici\u00f3n, y<\/li>\n\n\n\n<li>la l\u00f3gica que vincula los materiales, los procesos de fabricaci\u00f3n y el uso previsto del producto.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">En la pr\u00e1ctica, esto significa un mayor escrutinio de la trazabilidad de los datos, la coherencia cient\u00edfica y la justificaci\u00f3n toxicol\u00f3gica en todo el expediente.  <strong>Especialmente en las presentaciones a la FDA.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Para los fabricantes que dependen de <a href=\"https:\/\/sobelconsult.com\/es\/iso-10993-biocompatibility-what-changes-with-the-updated-standard\/\" target=\"_blank\" rel=\"noreferrer noopener\">las evaluaciones de biocompatibilidad<\/a>, la evaluaci\u00f3n del riesgo qu\u00edmico y la seguridad de los materiales. <strong>Es probable que<\/strong> este cambio <strong>afecte a la planificaci\u00f3n de los estudios, los plazos y la estrategia de documentaci\u00f3n.<\/strong> <\/p>\n\n<p class=\"wp-block-paragraph\">Las empresas que revisan proactivamente sus estrategias de evaluaci\u00f3n -alineando los estudios, informes y fundamentos normativos con las expectativas del Q3E- pueden reducir el riesgo de preguntas, solicitudes de informaci\u00f3n adicional y retrasos en el proceso normativo. Adem\u00e1s, pueden <strong>reforzar la calidad t\u00e9cnica general de sus presentaciones.<\/strong> <\/p>\n\n<p class=\"wp-block-paragraph\">Haz clic para comprobar la <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q3e-guideline-extractables-and-leachables\">directriz Q3E para Extra\u00edbles y Lixiviables.<\/a><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-health-canada-proposes-regulatory-changes-for-medical-devices\"><strong>Health Canada propone cambios normativos para los productos sanitarios<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Adem\u00e1s de la nueva directriz de la FDA sobre Extra\u00edbles y Lixiviables, <strong>el Ministerio de Sanidad de Canad\u00e1 tambi\u00e9n ha propuesto modernizar los requisitos reglamentarios de los productos sanitarios.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">En este contexto, la agencia canadiense ha <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/medical-devices-compliance-bulletin\/consultation-modernizing-mdel-framework-phase-ii.html\">abierto debates sobre iniciativas para actualizar el marco regulador de los productos sanitarios del pa\u00eds<\/a>. Los posibles ajustes pueden repercutir en los procesos de conformidad y vigilancia poscomercializaci\u00f3n. <\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Este tipo de cambio normativo merece una estrecha vigilancia<\/strong>, ya que puede influir en los plazos, los requisitos de pruebas y la planificaci\u00f3n de licencias a lo largo del ciclo de vida del producto.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-anvisa-updates-medical-device-regularization-manual\"><strong>Anvisa actualiza el Manual de Regularizaci\u00f3n de Productos Sanitarios<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">En Brasil, Anvisa ha publicado una <strong>nueva versi\u00f3n del <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2025\/anvisa-publica-nova-versao-de-manual-para-regularizacao-de-equipamentos-medicos\">Manual de Regularizaci\u00f3n de Productos Sanitarios<\/a>.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">El manual consolida las orientaciones actualizadas sobre <strong>clasificaci\u00f3n, requisitos de documentaci\u00f3n y procedimientos para la regularizaci\u00f3n reglamentaria en el pa\u00eds.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Como resultado, se espera que el material ayude a reducir las interpretaciones divergentes y apoye a los fabricantes en la toma de decisiones relacionadas con la clasificaci\u00f3n reglamentaria, la documentaci\u00f3n y las estrategias de presentaci\u00f3n.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"612\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-1024x612.jpg\" alt=\"Registro de productos sanitarios de Anvisa en el ordenador port&#xE1;til.\" class=\"wp-image-19147\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-1024x612.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-300x179.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-768x459.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration.jpg 1500w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-china-publishes-new-guidelines-to-accelerate-cosmetic-market-entry\"><strong>China publica nuevas directrices para acelerar la entrada en el mercado de los cosm\u00e9ticos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">M\u00e1s all\u00e1 de la actualizaci\u00f3n del manual de Brasil y de la directriz E&amp;L de la FDA, <strong>China ha publicado <a href=\"https:\/\/english.www.gov.cn\/news\/202511\/17\/content_WS691b1a63c6d00ca5f9a079e3.html\">nuevas directrices destinadas a estimular la innovaci\u00f3n y acelerar el acceso al mercado de los productos cosm\u00e9ticos<\/a>.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Las medidas pretenden aumentar la previsibilidad normativa, ajustar los procesos de evaluaci\u00f3n e incentivar los productos innovadores.<\/p>\n\n<p class=\"wp-block-paragraph\">Como resultado, las marcas que se plantean una expansi\u00f3n internacional (o que ya operan en la regi\u00f3n) tienen otra se\u00f1al clara de que el <strong>entorno normativo est\u00e1 evolucionando para equilibrar la rapidez y la supervisi\u00f3n.<\/strong><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-sobel-tip-iso-10993-1-guide-for-medical-devices\"><strong>Consejo Sobel: Gu\u00eda ISO 10993-1 para productos sanitarios<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Antes hemos hablado de la evaluaci\u00f3n de Extra\u00edbles y Lixiviables. Pero, \u00bfsab\u00edas que esto forma parte de una estrategia de biocompatibilidad m\u00e1s amplia <strong>estructurada en torno a la norma ISO 10993-1?<\/strong> <\/p>\n\n<p class=\"wp-block-paragraph\">Esta norma es la base de la evaluaci\u00f3n del riesgo biol\u00f3gico y qu\u00edmico de los productos sanitarios y orienta sobre c\u00f3mo definir, justificar y documentar la estrategia de pruebas a lo largo del ciclo de vida del producto.<\/p>\n\n<p class=\"wp-block-paragraph\">Recientemente, <strong>la norma ha sufrido importantes actualizaciones.<\/strong> Para facilitar la comprensi\u00f3n del \u00abantes y el despu\u00e9s\u00bb, hemos preparado una <a href=\"https:\/\/sobelconsult.com\/es\/materiais\/iso-10993-12025-guide\/\">Gu\u00eda ISO 10993-1:2025<\/a>.<\/p>\n\n<p class=\"wp-block-paragraph\">Desarrollada por el equipo de Seguridad Humana de Sobel, la gu\u00eda explica c\u00f3mo era la ISO 10993-1 anteriormente, qu\u00e9 ha cambiado y qu\u00e9 acciones se esperan de los fabricantes.  <strong>Y lo mejor de todo: \u00a1se puede descargar gratis!<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Desc\u00e1rgalo ahora:<\/strong> haz clic aqu\u00ed: https:\/\/sobelconsult.com\/materiais\/iso-10993-12025-guide<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-why-do-these-updates-matter\">\u00bfPor qu\u00e9 son importantes estas actualizaciones?<\/h2>\n\n<p class=\"wp-block-paragraph\">Estas actualizaciones refuerzan una tendencia mundial: un mayor rigor t\u00e9cnico, un impulso a la previsibilidad y actualizaciones continuas de los requisitos normativos, ya sea en temas muy t\u00e9cnicos (como Extra\u00edbles y Lixiviables) o en cambios estructurales de los marcos normativos y las orientaciones operativas.<\/p>\n\n<p class=\"wp-block-paragraph\">Para las empresas que operan en mercados regulados, mantenerse cerca de estos desarrollos forma parte de una planificaci\u00f3n eficaz del cumplimiento.<\/p>\n\n<p class=\"wp-block-paragraph\">Y recuerda: si quieres recibir estas actualizaciones r\u00e1pidamente, suscr\u00edbete gratis al <a href=\"https:\/\/sobelconsult.com\/es\/?popup=810\">Resumen de Noticias Sobel<\/a> y recibe en tu bandeja de entrada todo lo que pueda afectar a tu negocio.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La FDA ha publicado una nueva directriz alineada con la ICH Q3E para apoyar la evaluaci\u00f3n de los Extra\u00edbles y Lixiviables (E&amp;L), junto con documentaci\u00f3n de apoyo que incluye monograf\u00edas para los llamados lixiviables de Clase 3. El documento refuerza un enfoque basado en el riesgo, es decir,aumenta las expectativas en torno a: En la [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":24013,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"page_builder":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"categories":[140],"tags":[237,550],"market":[502],"content_type":[518],"class_list":["post-24297","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-productos-sanitarios","tag-evaluacion-biologica","tag-toxicologia-es","market-ee-uu","content_type-noticias-es"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Noticias: La FDA publica el Q3E de Extra\u00edbles y Lixiviables - Sobel<\/title>\n<meta name=\"description\" content=\"Mira qu\u00e9 cambia con la directriz Q3E de la FDA sobre Extra\u00edbles y Lixiviables, junto con las actualizaciones clave de Canad\u00e1, Brasil y China.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/es\/fda-publishes-q3e-for-extractables-leachables\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Noticias: La FDA publica el Q3E de Extra\u00edbles y Lixiviables\" \/>\n<meta property=\"og:description\" content=\"Mira qu\u00e9 cambia con la directriz Q3E de la FDA sobre Extra\u00edbles y Lixiviables, junto con las actualizaciones clave de Canad\u00e1, Brasil y China.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/es\/fda-publishes-q3e-for-extractables-leachables\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-19T11:01:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-10-24T09:40:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Maik Endler\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Maik Endler\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/fda-publishes-q3e-for-extractables-leachables\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/fda-publishes-q3e-for-extractables-leachables\\\/\"},\"author\":{\"name\":\"Maik Endler\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#\\\/schema\\\/person\\\/7cb020654e2f235d6175a2734c2b5e28\"},\"headline\":\"Noticias: La FDA publica el Q3E de Extra\u00edbles y Lixiviables\",\"datePublished\":\"2025-12-19T11:01:46+00:00\",\"dateModified\":\"2026-10-24T09:40:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/fda-publishes-q3e-for-extractables-leachables\\\/\"},\"wordCount\":839,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/fda-publishes-q3e-for-extractables-leachables\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/medical-device-ivd.jpg\",\"keywords\":[\"Evaluaci\u00f3n biol\u00f3gica\",\"Toxicolog\u00eda\"],\"articleSection\":[\"Productos sanitarios\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/fda-publishes-q3e-for-extractables-leachables\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/es\\\/fda-publishes-q3e-for-extractables-leachables\\\/\",\"name\":\"Noticias: La FDA publica el Q3E de Extra\u00edbles y Lixiviables - 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