{"id":6871,"date":"2018-03-16T17:27:04","date_gmt":"2018-03-16T16:27:04","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=6871"},"modified":"2023-01-24T15:05:26","modified_gmt":"2023-01-24T14:05:26","slug":"brasil-los-fabricantes-brasilenos-pueden-solicitar-la-certificacion-mdsap","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2018\/03\/16\/brasil-los-fabricantes-brasilenos-pueden-solicitar-la-certificacion-mdsap\/","title":{"rendered":"BRASIL: Los fabricantes brasile\u00f1os pueden solicitar la certificaci\u00f3n MDSAP"},"content":{"rendered":"<p>La certificaci\u00f3n MDSAP (Programa \u00danico de Auditor\u00eda de Dispositivos M\u00e9dicos) finalmente puede ser solicitada por<strong> fabricantes con sede en Brasil<\/strong> o en otros pa\u00edses pertenecientes al grupo del mercado \u00fanico de MERCOSUR (Argentina, Paraguay y Uruguay).<\/p>\n<p>Aunque el <strong>MDSAP<\/strong> es un programa de auditor\u00eda cuyos miembros son los EE. UU., Canad\u00e1, Brasil, Jap\u00f3n y Australia, hasta enero solo los fabricantes extranjeros registrados con ANVISA pod\u00edan solicitar dicha certificaci\u00f3n, excluyendo as\u00ed los fabricantes locales.<\/p>\n<p>Por lo tanto, es una novedad importante para el mercado brasile\u00f1o.\u00a0 De hecho, con la <strong>RDC 217\/2018<\/strong> emitida por la Autoridad Reguladora Brasile\u00f1a (ANVISA) en febrero de 2018, los fabricantes locales tienen la posibilidad de solicitar la certificaci\u00f3n del Sistema de Calidad de acuerdo con los requisitos del programa MDSAP.<\/p>\n<p>Para m\u00e1s informaci\u00f3n::<\/p>\n<p><a href=\"http:\/\/portal.anvisa.gov.br\/documents\/10181\/3612364\/RDC_217_2018_.pdf\/c510c05b-5693-469e-81b4-36bbd21324e5\">http:\/\/portal.anvisa.gov.br\/documents\/10181\/3612364\/RDC_217_2018_.pdf\/c510c05b-5693-469e-81b4-36bbd21324e5<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La certificaci\u00f3n MDSAP (Programa \u00danico de Auditor\u00eda de Dispositivos M\u00e9dicos) finalmente puede ser solicitada por fabricantes con sede en Brasil o  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-6871","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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