{"id":32892,"date":"2024-07-22T15:21:07","date_gmt":"2024-07-22T13:21:07","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/07\/22\/novita-per-gli-operatori-economici-linea-guida-per-gli-incidenti-e-modulo-di-registrazione\/"},"modified":"2024-07-23T08:45:25","modified_gmt":"2024-07-23T06:45:25","slug":"novita-per-gli-operatori-economici-linea-guida-per-gli-incidenti-e-modulo-di-registrazione","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/07\/22\/novita-per-gli-operatori-economici-linea-guida-per-gli-incidenti-e-modulo-di-registrazione\/","title":{"rendered":"Novedad para los operadores econ\u00f3micos: directriz sobre accidentes y formulario de inscripci\u00f3n"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2><strong>A partir del 3 de junio de 2024 <\/strong>es v\u00e1lido en Suiza el <strong><em>Guidance Document Incident Economic Operators<\/em>, <\/strong>un documento que en once puntos describe y aclara los requisitos a cumplir en caso de accidente, especificando las obligaciones para los Operadores Econ\u00f3micos: Fabricantes, Distribuidores, Importadores y Representantes Autorizados.<\/h2>\n<p>El documento aclara, en primer lugar, la diferencia <strong>entre accidente y accidente grave<\/strong>, primer aspecto que debe aclararse para operar en plena conformidad.<\/p>\n<p>Un <strong>accidente <\/strong>es un suceso resultante de cualquier mal funcionamiento o deterioro de las caracter\u00edsticas o prestaciones de un producto comercializado, incluidos los errores de uso debidos a caracter\u00edsticas ergon\u00f3micas, as\u00ed como cualquier insuficiencia en la informaci\u00f3n facilitada por el fabricante. Seg\u00fan el Reglamento suizo sobre productos sanitarios MedDO, el t\u00e9rmino accidente abarca tambi\u00e9n cualquier efecto secundario no deseado y, en el caso del Reglamento sobre productos para diagn\u00f3stico in vitro IvDO, tambi\u00e9n cubre cualquier da\u00f1o resultante de una decisi\u00f3n o acci\u00f3n m\u00e9dica no adoptada sobre la base de la informaci\u00f3n o los resultados proporcionados por el producto.<\/p>\n<p>Un <strong>accidente grave <\/strong>es un accidente que ha causado, puede haber causado o puede causar, directamente o indirectamente, la muerte de un paciente, usuario u otra persona; el deterioro grave temporal o permanente del estado de salud de un paciente, usuario u otra persona; una amenaza grave para la salud p\u00fablica. <strong>Los incidentes graves <\/strong>ocurridos en Suiza deben notificarse a <strong>Swissmedic<\/strong>, que recoge y examina sistem\u00e1ticamente cada informe.<\/p>\n<p>El documento aclara las funciones y responsabilidades de los <strong>agentes econ\u00f3micos <\/strong>implicados tras un accidente: los fabricantes, importadores y distribuidores tienen obligaciones espec\u00edficas, al igual que el papel del <strong>representante autorizado<\/strong> <strong>local<\/strong>. Por ejemplo, si el fabricante no tiene su sede en Suiza o Liechtenstein, su <strong>Representante<\/strong> <strong>Autorizado <\/strong>es responsable de informar; el Representante Autorizado tambi\u00e9n est\u00e1 obligado a informar inmediatamente al fabricante de cualquier reclamaci\u00f3n o informe relativo a un producto para el que haya sido designado Representante Autorizado.<\/p>\n<p>La directriz define detalladamente <strong>c\u00f3mo debe transmitirse electr\u00f3nicamente el informe <\/strong>de incidente grave. Es esencial ser consciente de lo ajustado del plazo: si el incidente grave constituye claramente, o puede constituir, una amenaza grave e inminente para <strong>la vida o la salud de un gran n\u00famero de personas<\/strong>, el informe debe presentarse <strong>inmediatamente, y a m\u00e1s tardar dos d\u00edas naturales <\/strong>despu\u00e9s de que se haya tenido conocimiento del mismo.<br \/>\nSi el accidente grave ha provocado la muerte o el deterioro grave e imprevisto del estado de salud de una persona, el informe debe presentarse sin demora y a m\u00e1s tardar en el <strong>plazo de 10 d\u00edas naturales. <\/strong>Todos los dem\u00e1s incidentes graves deben notificarse sin demora y <strong>a m\u00e1s tardar<\/strong> <strong>15 d\u00edas naturales <\/strong>despu\u00e9s de haber tenido conocimiento del incidente.<\/p>\n<p>Las disposiciones aplicables deben resumirse y presentarse en un lenguaje f\u00e1cilmente comprensible y de forma que puedan utilizarse directamente en la pr\u00e1ctica.<\/p>\n<p>El sistema de notificaci\u00f3n est\u00e1 dise\u00f1ado para proteger la salud de pacientes y usuarios. En concreto, pretende evitar que se repitan accidentes basados en problemas de dise\u00f1o, fabricaci\u00f3n o uso de los productos.<\/p>\n<p>Encontrar\u00e1 mucha m\u00e1s informaci\u00f3n en la <a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/de\/dokumente\/medizinprodukte\/mep_urr\/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf\/MU680_20_009d_WL_Vorkommnis_Wirtschaftsakteure.pdf\">gu\u00eda completa<\/a>.<\/p>\n<h2><strong>Formulario de inscripci\u00f3n Swissdamed<\/strong><\/h2>\n<p>Relevante para quienes comercializan productos sanitarios en Suiza es el <strong>formulario de solicitud CHRN <\/strong>que, a partir de <strong>agosto de 2024, <\/strong>estar\u00e1 disponible para el registro de Operadores Econ\u00f3micos. Con este formulario, los Operadores Econ\u00f3micos se registrar\u00e1n exclusivamente a trav\u00e9s de la base de datos suiza <strong>sobre productos sanitarios (SWISSDAMED), la <\/strong>base de datos que, al igual que Eudamed, pretende crear m\u00e1s transparencia, en particular mejorando el acceso a la informaci\u00f3n para el p\u00fablico y los profesionales de la salud.<br \/>\nSe recuerda que el CHRN es un n\u00famero de registro suizo \u00fanico que Swissmedic asigna previa solicitud, una sola vez, a los Operadores Econ\u00f3micos interesados.<\/p>\n<p>Las solicitudes de registro y modificaci\u00f3n de la CHRN, as\u00ed como las notificaciones de mandatos, seguir\u00e1n acept\u00e1ndose en formato PDF hasta el <strong>26 de julio de 2024 <\/strong>(fecha de presentaci\u00f3n). Despu\u00e9s de esta fecha, ya no se tendr\u00e1n en cuenta estos formularios.<\/p>\n<p>&gt;&gt; \u00bfEs usted un fabricante con sede fuera de Suiza y desea comercializar sus productos en Suiza? Thema puede ser su <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/servizio-rappresentante-autorizzato-svizzero\/\">representante autorizado suizo (CH REP)<\/a>, garantizando el cumplimiento de todas las obligaciones y acompa\u00f1\u00e1ndole con \u00e9xito al mercado.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>FUENTES: <\/strong><\/p>\n<p><strong><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/de\/dokumente\/medizinprodukte\/mep_urr\/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf\/MU680_20_009d_WL_Vorkommnis_Wirtschaftsakteure.pdf\">Guidance document Incident Economic Operators<\/a><\/strong><\/p>\n<p><strong><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/registriernummer-chrn.html\">Registering economic operators (CHRN) (swissmedic.ch)<\/a><\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32885,"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-32892","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 - 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