{"id":3706,"date":"2017-07-18T12:24:20","date_gmt":"2017-07-18T10:24:20","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=3706\/"},"modified":"2017-07-18T12:24:20","modified_gmt":"2017-07-18T10:24:20","slug":"vender-en-china-que-responsabilidades-tiene-el-legal-agent","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/vender-en-china-que-responsabilidades-tiene-el-legal-agent\/","title":{"rendered":"Vender en China: \u00bfqu\u00e9 responsabilidades tiene un Agente Autorizado?"},"content":{"rendered":"

Para vender dispositivos m\u00e9dicos en China es necesario designar a un Agente Autorizado establecido en tal pa\u00eds que desempe\u00f1e un papel importante tanto en la fase anterior como posterior a la comercializaci\u00f3n.
\nPara la registraci\u00f3n, el Agente Autorizado juega un papel de interfaz con la autoridad competente, ayuda al fabricante extranjero para una correcta clasificaci\u00f3n del dispositivo, en el proceso de registraci\u00f3n que hay que seguir y en la determinaci\u00f3n de la necesidad de llevar a cabo estudios clinicos. En general, el Agente Autorizado desempe\u00f1a un papel de coordinaci\u00f3n durante todo el proceso de registraci\u00f3n ante la autoridad competente (CFDA). Una vez obtenida la registraci\u00f3n, esta pertenece al Agente Autorizado, cuyas referencias deben necesariamente aparecer en la etiqueta. A partir de este momento el Agente Autorizado chino ser\u00e1 la referencia del CFDA para la gesti\u00f3n de cualquier comunicaci\u00f3n dirigida al fabricante extranjero. Adem\u00e1s, el Agente Autorizado tendr\u00e1 que garantizar el mantenimiento del certificado de registraci\u00f3n, su modificaci\u00f3n y actualizaci\u00f3n cuando sea necesario. Por \u00faltimo, las actividades de gesti\u00f3n de las reclamaciones, de notificaci\u00f3n y de retirada forman parte de sus competencias.<\/p>\n","protected":false},"excerpt":{"rendered":"

Para vender dispositivos m\u00e9dicos en China es necesario designar a un Agente Autorizado establecido en tal pa\u00eds que desempe\u00f1e un papel […]<\/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":[1557,891],"tags":[],"class_list":["post-3706","post","type-post","status-publish","format-standard","hentry","category-como-registrar-los-dispositivos-medicos-en-el-mundo-faq-es","category-faq-es"],"acf":[],"yoast_head":"\nVender en China: \u00bfqu\u00e9 responsabilidades tiene un Agente Autorizado?<\/title>\n<meta name=\"description\" content=\"Para vender dispositivos m\u00e9dicos en China es necesario designar a un Agente Autorizado establecido en tal pa\u00eds que desempe\u00f1e un papel importante...\" \/>\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\/2017\/07\/18\/vender-en-china-que-responsabilidades-tiene-el-legal-agent\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vender en China: \u00bfqu\u00e9 responsabilidades tiene un Agente Autorizado?\" \/>\n<meta property=\"og:description\" content=\"Para vender dispositivos m\u00e9dicos en China es necesario designar a un Agente Autorizado establecido en tal pa\u00eds que desempe\u00f1e un papel importante...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/vender-en-china-que-responsabilidades-tiene-el-legal-agent\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - 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