{"id":9196,"date":"2019-03-18T11:43:12","date_gmt":"2019-03-18T10:43:12","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9196"},"modified":"2023-01-26T11:46:09","modified_gmt":"2023-01-26T10:46:09","slug":"brasil-nueva-ruta-de-notificacion-anvisa-para-dispositivos-medicos-de-clase-i","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/03\/18\/brasil-nueva-ruta-de-notificacion-anvisa-para-dispositivos-medicos-de-clase-i\/","title":{"rendered":"BRASIL: nueva ruta de notificaci\u00f3n ANVISA para dispositivos m\u00e9dicos de Clase I"},"content":{"rendered":"\r\n<p>Para simplificar el procedimiento para comercializar dispositivos m\u00e9dicos de bajo riesgo, el 1 de marzo de 2019, la Autoridad Reguladora de Brasil ANVISA (<em>Agencia Nacional de Vigil\u00e2ncia Sanit\u00e1ria<\/em>) emiti\u00f3 una <a href=\"http:\/\/portal.anvisa.gov.br\/documents\/10181\/3741322\/RDC_270_2019_.pdf\/c7b53ecb-21ba-4c6a-846a-ea9e4aca690d\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">RDC 270\/2019<\/a>, estableciendo una ruta basada en notificaciones de producto, una comunicaci\u00f3n simple, para dispositivos m\u00e9dicos de Clase I y IVD, que reemplaza al llamado \u00ab<em>Cadastramento<\/em>\u00ab.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-9150\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/03\/BRASILE-nuovo-percorso-di-notifica-ANVISA-per-i-dispositivi-medici-di-Classe-I-1024x536.png\" alt=\"\" \/>\r\n<figcaption><em>Nueva ruta de notificaci\u00f3n ANVISA para dispositivos m\u00e9dicos de Clase I en\u00a0Brasil<\/em><\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>Con la entrada en vigor de la RDC 270\/2019 en mayo de 2019, los registros de los dispositivos ya existentes incluidos en el \u00ab<em>cadastro<\/em>\u00bb se convertir\u00e1n autom\u00e1ticamente en notificaciones y su n\u00famero de notificaci\u00f3n ser\u00e1 id\u00e9ntico al n\u00famero de registro (antiguo).<\/p>\r\n\r\n\r\n\r\n<p>Una vez que la nueva ruta entre en vigor, ANVISA emitir\u00e1 un <em>notification number<\/em> al solicitante dentro de los 30 d\u00edas, public\u00e1ndolo en el sitio web de la Agencia en lugar de hacerlo en el Diario Oficial. Una vez emitido, el n\u00famero de notificaci\u00f3n debe agregarse a la etiqueta del producto para que el fabricante pueda comercializar sus dispositivos en Brasil.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Para simplificar el procedimiento para comercializar dispositivos m\u00e9dicos de bajo riesgo, el 1 de marzo de 2019, la Autoridad Reguladora de  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23440,"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":[3],"tags":[],"class_list":["post-9196","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BRASIL: nueva ruta de notificaci\u00f3n ANVISA para dispositivos m\u00e9dicos de Clase I - 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