{"id":7832,"date":"2018-08-29T09:47:51","date_gmt":"2018-08-29T07:47:51","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7832"},"modified":"2023-07-28T15:05:24","modified_gmt":"2023-07-28T13:05:24","slug":"que-es-el-product-initial-report-para-el-cdrh","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/08\/29\/que-es-el-product-initial-report-para-el-cdrh\/","title":{"rendered":"\u00bfQu\u00e9 es el Product (Initial) Report para el CDRH?"},"content":{"rendered":"<p>Para comercializar en EE.UU. productos sanitarios que emiten determinados tipos de radiaci\u00f3n (v\u00e9ase 21 CFR 1002.1 para m\u00e1s detalles), debe enviarse un Informe (Inicial) del Producto al CDRH para obtener un N\u00famero de Admisi\u00f3n. Se recomienda que el informe se env\u00ede al CDRH al menos un mes antes de la fecha prevista de comercializaci\u00f3n para que el CDRH disponga de tiempo suficiente para enviar al fabricante la carta de acuse de recibo con el n\u00famero de acceso, es decir, el n\u00famero de identificaci\u00f3n del informe presentado.<\/p>\n<p>El N\u00famero de Admisi\u00f3n debe comunicarse entonces al importador en el territorio para efectuar la entrada legal en los EE.UU.. Este N\u00famero de Admisi\u00f3n ser\u00e1 comprobado por la Aduana a la entrada de la mercanc\u00eda y, en su ausencia, se bloquear\u00e1 su tr\u00e1nsito.<\/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>Adem\u00e1s, la notificaci\u00f3n anual (antes del 1 de septiembre) debe realizarse 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 en EE.UU. productos sanitarios que emiten determinados tipos de radiaci\u00f3n (v\u00e9ase 21 CFR 1002.1 para m\u00e1s detalles), debe enviarse  [&#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-7832","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 Product (Initial) Report para el CDRH? 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