{"id":7828,"date":"2018-08-29T09:42:24","date_gmt":"2018-08-29T07:42:24","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7828"},"modified":"2023-07-28T15:02:00","modified_gmt":"2023-07-28T13:02:00","slug":"que-es-el-numero-de-ingreso","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/08\/29\/que-es-el-numero-de-ingreso\/","title":{"rendered":"\u00bfQu\u00e9 es el N\u00famero de ingreso?"},"content":{"rendered":"<p>Para comercializar productos sanitarios que emiten determinados tipos de radiaci\u00f3n en los EE.UU. (v\u00e9ase 21 CFR 1002.1 para m\u00e1s detalles), debe presentarse un Informe (inicial) del producto al CDRH. El CDRH env\u00eda al fabricante una carta de acuse de recibo que contiene el n\u00famero de acceso, un identificador \u00fanico del informe presentado.<\/p>\n<p>Este n\u00famero de acceso permite a las autoridades aduaneras (personal de importaci\u00f3n de la FDA) confirmar que el fabricante ha cumplido al menos los requisitos de 21 CFR 1002.10 Informes de producto para el producto que se est\u00e1 importando. Sin este n\u00famero, se bloquear\u00e1 el tr\u00e1nsito del producto.<\/p>\n<p>En caso de que se produzca un cambio en la dosis de liberaci\u00f3n o un cambio en los informes de las pruebas de seguridad del producto, deber\u00e1 enviarse al CDRH un Informe Complementario que contenga la informaci\u00f3n modificada.<\/p>\n<p>Anualmente (antes del 1 de septiembre), tambi\u00e9n debe mantenerse la notificaci\u00f3n mediante el env\u00edo de un Informe Anual al CDRH en el que se indiquen, entre otras cosas, las unidades comercializadas en EE.UU. durante el periodo de notificaci\u00f3n.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Para comercializar productos sanitarios que emiten determinados tipos de radiaci\u00f3n en los EE.UU. (v\u00e9ase 21 CFR 1002.1 para m\u00e1s detalles), debe  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1562,891],"tags":[],"class_list":["post-7828","post","type-post","status-publish","format-standard","hentry","category-como-registrar-dispositivos-medicos-que-emiten-radiaciones-en-el-cdrh-es-faq-es","category-faq-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00bfQu\u00e9 es el N\u00famero de ingreso? - Thema - Medical Regulatory Consultancy<\/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.thema-med.com\/es\/2018\/08\/29\/que-es-el-numero-de-ingreso\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00bfQu\u00e9 es el N\u00famero de ingreso? - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"Para comercializar productos sanitarios que emiten determinados tipos de radiaci\u00f3n en los EE.UU. 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