{"id":20940,"date":"2022-05-30T13:53:12","date_gmt":"2022-05-30T11:53:12","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20940"},"modified":"2022-05-30T13:59:52","modified_gmt":"2022-05-30T11:59:52","slug":"brasil-rdc-665-2022-aplicacion-bgmp-brazilian-good-manufacturing-pratices","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2022\/05\/30\/brasil-rdc-665-2022-aplicacion-bgmp-brazilian-good-manufacturing-pratices\/","title":{"rendered":"BRASIL: RDC 665\/2022 por aplicaci\u00f3n BGMP (Brazilian Good Manufacturing Practices)"},"content":{"rendered":"\n

ANVISA<\/strong> – Autoridad Reguladora Brasile\u00f1a – ha publicado la RDC 665\/2022<\/strong> (entrada en vigor el pasado 2 de mayo), resoluci\u00f3n que reescribe los requisitos BGMP (Brazilian Good Manufacturing Practices) <\/strong>para los dispositivos m\u00e9dicos y los IVD, convirti\u00e9ndose ahora en el punto de referencia para la adaptaci\u00f3n del Sistema de Gesti\u00f3n de la Calidad de los Fabricantes que comercializan dispositivos en territorio brasile\u00f1o, ya sea sin o con adhesi\u00f3n al programa MDSAP.<\/p>\n\n\n\n

La RDC 665\/2022\nsustituye a la RDC 16\/2013 y a la IN 08\/2013.<\/p>\n\n\n\n

\"BRASIL:
BRASIL: RDC 665\/2022 por aplicaci\u00f3n BGMP (Brazilian Good Manufacturing Practices)<\/figcaption><\/figure>\n\n\n\n

Requisitos de la RDC 665\/2022<\/strong><\/h2>\n\n\n\n

La Resoluci\u00f3n 665\/2022<\/strong> de la RDC define los requisitos brasile\u00f1os del Sistema de Gesti\u00f3n de la Calidad (SGC) que deben seguirse con respecto a los m\u00e9todos, controles y otros procesos relacionados con el dise\u00f1o, la compra y la fabricaci\u00f3n de dispositivos m\u00e9dicos y el IVD.<\/p>\n\n\n\n

Entre los cambios\nm\u00e1s significativos se menciona la obligaci\u00f3n de establecer responsabilidades,\nautoridad e interrelaci\u00f3n de todo el personal que gestiona y verifica el\nsistema de gesti\u00f3n de la Calidad en la empresa, as\u00ed como la prueba de que los\nProveedores han recibido las especificaciones de los bienes y servicios\nsuministrados y la extensi\u00f3n a los Importadores de control de etiquetas e IFU. <\/p>\n\n\n\n

Los BGMP\nintroducidos por la Resoluci\u00f3n 665\/2022 de la RDC se aplican a los Fabricantes\ne Importadores, as\u00ed como a los distribuidores y revendedores que operan en\nBrasil. La entrada en vigor de esta resoluci\u00f3n hace necesaria la adaptaci\u00f3n del\nSistema de Gesti\u00f3n de la Calidad de la organizaci\u00f3n certificada por MDSAP o que\nsimplemente exporte los dispositivos al territorio a los requisitos\nactualizados.<\/p>\n\n\n\n

\u00bfSu empresa comercializa dispositivos m\u00e9dicos en Brasil? <\/strong><\/h2>\n\n\n\n

Le recordamos que\nsi su organizaci\u00f3n est\u00e1 certificada por MDSAP<\/strong> para el mercado brasile\u00f1o\no, de todos modos, comercializa dispositivos en Brasil, deber\u00e1 aplicar los\nrequisitos BGMP de la RDC 665\/2022 y aplicar los requisitos regulatorios para\nestar listo para la pr\u00f3xima visita de inspecci\u00f3n de MDSAP o ANVISA.<\/p>\n\n\n\n

Elija Thema como su socio de confianza<\/strong> para la adaptaci\u00f3n de su Sistema de Gesti\u00f3n de la Calidad a los requisitos\nBGMP ahora en vigor y podr\u00e1 comercializar sus dispositivos de forma r\u00e1pida y en\npleno cumplimiento de los requisitos reguladores requeridos.<\/p>\n\n\n\n

Se ponga en cont\u00e1cto con nuestro Customer Service<\/strong><\/a> para obtener m\u00e1s informaci\u00f3n!<\/p>\n\n\n\n

Fuente: <\/em><\/p>\n\n\n\n

RDC 665\/2022, Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria\n(ANVISA), 30 marzo 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

ANVISA – Autoridad Reguladora Brasile\u00f1a – ha publicado la RDC 665\/2022 (entrada en vigor el pasado 2 de mayo), resoluci\u00f3n que […]<\/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":[1,2],"tags":[],"class_list":["post-20940","post","type-post","status-publish","format-standard","hentry","category-news","category-news-en"],"acf":[],"yoast_head":"\nBRASIL: aplicaci\u00f3n BGMP (Brazilian Good Manufacturing Practices)<\/title>\n<meta name=\"description\" content=\"ANVISA ha publicado la RDC 665\/2022 que reescribe los requisitos BGMP (Brazilian Good Manufacturing Practices) para los dispositivos m\u00e9dicos y los IVD\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/es\/2022\/05\/30\/brasil-rdc-665-2022-aplicacion-bgmp-brazilian-good-manufacturing-pratices\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BRASIL: aplicaci\u00f3n BGMP (Brazilian Good Manufacturing Practices)\" \/>\n<meta property=\"og:description\" content=\"ANVISA ha publicado la RDC 665\/2022 que reescribe los requisitos BGMP (Brazilian Good Manufacturing Practices) para los dispositivos m\u00e9dicos y los IVD\" \/>\n<meta property=\"og:url\" content=\"http:\/\/www.thema-med.com\/es\/2022\/05\/30\/brasil-rdc-665-2022-aplicacion-bgmp-brazilian-good-manufacturing-pratices\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - 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