{"id":8728,"date":"2025-09-30T11:05:14","date_gmt":"2025-09-30T03:05:14","guid":{"rendered":"https:\/\/regask.com\/?p=8728"},"modified":"2025-09-30T11:05:14","modified_gmt":"2025-09-30T03:05:14","slug":"estados-unidos-inicia-una-investigacion-sobre-las-importaciones-de-dispositivos-medicos-y-epi","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/u-s-launches-investigation-into-medical-device-and-ppe-imports\/","title":{"rendered":"EE.UU. inicia investigaci\u00f3n sobre dispositivos m\u00e9dicos y EPI\u2026"},"content":{"rendered":"<p>En <strong>26 de septiembre de 2025<\/strong>, el <a href=\"https:\/\/media.bis.gov\/\"><strong>Oficina de Industria y Seguridad (BIS) del Departamento de Comercio de los Estados Unidos<\/strong><\/a> anunci\u00f3 un <strong>Investigaci\u00f3n de la secci\u00f3n 232<\/strong> sobre si la dependencia de las importaciones de <strong>equipo de protecci\u00f3n personal (EPP), consumibles m\u00e9dicos y dispositivos m\u00e9dicos<\/strong> plantea riesgos para la seguridad nacional de EE. UU. El Departamento est\u00e1 invitando al p\u00fablico a comentar sobre el asunto, con una fecha l\u00edmite de presentaci\u00f3n de <strong>17 de octubre de 2025<\/strong>.<\/p>\n<div class=\"row\"  id=\"row-1439296421\">\n\n\t<div id=\"col-223330519\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Alcance de la investigaci\u00f3n<\/h3>\n\t<div id=\"gap-392937950\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-392937950 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La investigaci\u00f3n abarca una amplia gama de productos relacionados con la atenci\u00f3n sanitaria, incluidos <strong>EPI (mascarillas, guantes)<\/strong>, <strong>consumibles m\u00e9dicos (jeringas, bolsas intravenosas)<\/strong>, <strong>equipo m\u00e9dico duradero (camas de hospital)<\/strong>, y <strong>dispositivos m\u00e9dicos (marcapasos, ventiladores)<\/strong>El BIS evaluar\u00e1 la capacidad de producci\u00f3n interna en relaci\u00f3n con la demanda, los riesgos vinculados a las cadenas de suministro extranjeras concentradas y las posibles vulnerabilidades creadas por las pr\u00e1cticas comerciales globales.<\/p>\n<p>El Departamento est\u00e1 particularmente interesado en datos sobre:<\/p>\n<ul>\n<li>El equilibrio entre <strong>Capacidad de fabricaci\u00f3n nacional y demanda estadounidense<\/strong>.<\/li>\n<li>Riesgos de <strong>subsidios extranjeros, restricciones a la exportaci\u00f3n y pr\u00e1cticas comerciales predatorias<\/strong>.<\/li>\n<li>La viabilidad de <strong>Aumentar la capacidad de producci\u00f3n de EE.UU.<\/strong> para reducir la dependencia de las importaciones.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-223330519 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-674491798\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Fecha l\u00edmite para comentarios<\/h3>\n\t<div id=\"gap-1211297105\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1211297105 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los comentarios p\u00fablicos deben enviarse a la <a href=\"https:\/\/www.regulations.gov\/\"><strong>Portal de reglamentaci\u00f3n federal<\/strong><\/a><strong> para el 17 de octubre de 2025<\/strong>La informaci\u00f3n comercial confidencial debe estar claramente identificada y acompa\u00f1ada de una versi\u00f3n no confidencial para el registro p\u00fablico.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-674491798 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-187248334\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Por qu\u00e9 es importante<\/h3>\n\t<div id=\"gap-1770625251\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1770625251 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta investigaci\u00f3n tiene implicaciones significativas para la industria de la salud. Si la BIS determina que la dependencia de las importaciones socava la seguridad nacional de EE. UU., el potencial... <strong>restricciones comerciales como aranceles o cuotas<\/strong> Podr\u00edan seguir estas medidas. <strong>aumentar los costos de adquisici\u00f3n<\/strong>, interrumpir <strong>cadenas de suministro globales<\/strong>y aumentar la presi\u00f3n sobre los fabricantes estadounidenses para que aumenten r\u00e1pidamente la producci\u00f3n. <strong>proveedores de atenci\u00f3n m\u00e9dica, distribuidores y empresas de dispositivos<\/strong>, el resultado podr\u00eda afectar <strong>Precios, estrategias de abastecimiento y acceso oportuno de los pacientes<\/strong> a productos cr\u00edticos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-187248334 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1675597359\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u00bfQui\u00e9n deber\u00eda prestar atenci\u00f3n?<\/h3>\n\t<div id=\"gap-902940626\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-902940626 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Este aviso es especialmente relevante para <strong>fabricantes, distribuidores, proveedores de atenci\u00f3n m\u00e9dica y asociaciones industriales<\/strong> dedicada a la producci\u00f3n, importaci\u00f3n o distribuci\u00f3n de EPP, consumibles y dispositivos m\u00e9dicos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1675597359 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-28855397\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Pr\u00f3ximos pasos<\/h3>\n\t<div id=\"gap-597916612\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-597916612 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dada la breve ventana de comentarios, se recomienda a las partes interesadas que: <strong>Preparar presentaciones formales con datos, an\u00e1lisis y perspectivas<\/strong> sobre c\u00f3mo las posibles restricciones podr\u00edan afectar las operaciones. Seguimiento estrecho del expediente de investigaci\u00f3n y consulta con <strong>asesor comercial y regulatorio<\/strong> Se recomiendan, ya que cualquier resultado de pol\u00edtica podr\u00eda transformar <strong>Resiliencia de la cadena de suministro y obligaciones de cumplimiento<\/strong> en el corto plazo.<\/p>\n<p>Al participar activamente, las organizaciones pueden garantizar que sus inquietudes sean escuchadas y que las futuras decisiones pol\u00edticas reflejen la realidad de las cadenas de suministro de productos m\u00e9dicos. Esta tambi\u00e9n es una oportunidad crucial para alinear las estrategias de abastecimiento con los marcos comerciales y regulatorios en constante evoluci\u00f3n.<\/p>\n<p>A medida que las empresas eval\u00faan el impacto de estos desarrollos, recurren cada vez m\u00e1s a soluciones de inteligencia regulatoria avanzada para obtener informaci\u00f3n predictiva y agilidad en el cumplimiento.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a><strong> es una soluci\u00f3n de agente impulsada por IA para inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo <\/strong>Esto simplifica el cumplimiento normativo, reduce el riesgo y acelera la entrada al mercado. Al combinar contenido seleccionado, informaci\u00f3n pr\u00e1ctica y documentaci\u00f3n inteligente con una comunidad conectada de m\u00e1s de 1700 expertos en la materia, RegASK permite una ejecuci\u00f3n regulatoria inteligente de principio a fin durante todo el ciclo de vida del producto.<\/p>\n<p><a href=\"https:\/\/regask.com\/es\/producto\/\">M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reservar una demostraci\u00f3n<\/a> hoy.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-28855397 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1329882233\">\n\n\t<div id=\"col-902787124\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n\t<div id=\"gap-1418379337\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1418379337 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1038938204\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1038938204 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 es una investigaci\u00f3n de la Secci\u00f3n 232?<\/h4>\n\t<div id=\"gap-681022854\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-681022854 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Una investigaci\u00f3n de la Secci\u00f3n 232 eval\u00faa si ciertas importaciones plantean riesgos a la seguridad nacional de Estados Unidos, lo que podr\u00eda dar lugar a medidas comerciales como aranceles o cuotas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-902787124 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-534249409\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfQu\u00e9 productos est\u00e1n incluidos en esta investigaci\u00f3n?<\/h4>\n\t<div id=\"gap-1986045794\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1986045794 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La investigaci\u00f3n abarca <strong>EPP (mascarillas, guantes), consumibles m\u00e9dicos (jeringas, bolsas de suero), equipo m\u00e9dico duradero (camas de hospital) y dispositivos m\u00e9dicos (marcapasos, ventiladores)<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-534249409 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-515093363\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfCu\u00e1l es la fecha l\u00edmite para enviar comentarios?<\/h4>\n\t<div id=\"gap-1161116335\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1161116335 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los comentarios p\u00fablicos deben enviarse a la <a href=\"https:\/\/www.regulations.gov\/\"><strong>Portal de reglamentaci\u00f3n federal<\/strong><\/a><strong> para el 17 de octubre de 2025<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-515093363 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-360320834\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfQu\u00e9 papel juega el RegASK para ayudar a las organizaciones a adaptarse a los cambios regulatorios?<\/h4>\n\t<div id=\"gap-354776802\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-354776802 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/es\/\">RegASK<\/a> Ayuda a las organizaciones a adaptarse a los cambios regulatorios mediante inteligencia artificial y orquestaci\u00f3n de flujos de trabajo. Permite a los equipos realizar un seguimiento oportuno de las actualizaciones, evaluar los riesgos y optimizar las respuestas, garantizando el cumplimiento normativo incluso durante cambios en las pol\u00edticas, como la investigaci\u00f3n de la Secci\u00f3n 232.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-360320834 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On September 26, 2025, the U.S. Department of Commerce\u2019s Bureau of Industry and Security (BIS) announced a Section 232 investigation into whether reliance on imports of personal protective equipment (PPE), medical consumables, and medical devices poses risks to U.S. national security. The Department is inviting public comments on the matter, with a submission deadline of&#8230;<\/p>","protected":false},"author":32,"featured_media":8729,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,39],"tags":[],"class_list":["post-8728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>U.S. Launches Investigation into Medical Device and PPE Imports | RegASK<\/title>\n<meta name=\"description\" content=\"The U.S. is examining national security risks of imported medical devices and PPE. 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Submit your comments before the deadline.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/estados-unidos-inicia-una-investigacion-sobre-las-importaciones-de-dispositivos-medicos-y-epi\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-30T03:05:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/us-launches-investigation-medical-device-ppe-imports.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Hannah Nordin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Hannah Nordin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/\"},\"author\":{\"name\":\"Hannah Nordin\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\"},\"headline\":\"U.S. Launches Investigation into Medical Device and PPE&hellip;\",\"datePublished\":\"2025-09-30T03:05:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/\"},\"wordCount\":739,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/us-launches-investigation-medical-device-ppe-imports.png\",\"articleSection\":[\"United States\",\"Regulatory News\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/\",\"name\":\"U.S. Launches Investigation into Medical Device and PPE Imports | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/u-s-launches-investigation-into-medical-device-and-ppe-imports\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/us-launches-investigation-medical-device-ppe-imports.png\",\"datePublished\":\"2025-09-30T03:05:14+00:00\",\"description\":\"The U.S. is examining national security risks of imported medical devices and PPE. 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