{"id":30918,"date":"2023-10-20T17:22:38","date_gmt":"2023-10-20T15:22:38","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=30918"},"modified":"2023-10-20T17:23:46","modified_gmt":"2023-10-20T15:23:46","slug":"suiza-regulacion-de-los-productos-no-destinados-a-uso-medico","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/10\/20\/suiza-regulacion-de-los-productos-no-destinados-a-uso-medico\/","title":{"rendered":"SUIZA: regulaci\u00f3n de los productos no destinados a uso m\u00e9dico"},"content":{"rendered":"<h2>El 29 de septiembre de 2023, el Consejo Federal Suizo modific\u00f3 la Ordenanza de Productos Sanitarios para mejorar la seguridad de los productos no destinados a uso m\u00e9dico, <strong>aline\u00e1ndola<\/strong> con los requisitos de la Uni\u00f3n Europea. Tambi\u00e9n se aprovech\u00f3 la oportunidad para adaptar las Ordenanzas sobre productos sanitarios (ODmed) y sobre productos sanitarios para diagn\u00f3stico in vitro (ODIV) al Reglamento (UE) 2023\/607. Las revisiones de la ODmed y la ODIV, aprobadas el pasado mes de septiembre, entrar\u00e1n en vigor el <strong>1 de noviembre de 2023<\/strong>.<\/h2>\n<p>&nbsp;<\/p>\n<p>En cuanto a los productos sin finalidad m\u00e9dica, que se utilizan principalmente en cosm\u00e9tica, cirug\u00eda est\u00e9tica, modelado corporal y \u00f3ptica, se establece que, al igual que el MDR (UE) 2017\/745, ser\u00e1n regulados por el ODmed ya que sus funciones y perfiles de riesgo son similares a los de los productos sanitarios.<\/p>\n<p>&nbsp;<\/p>\n<p>Hay varias partes de la medida que ahora regulan estos dispositivos. El art\u00edculo 15 y el anexo 5 regulan la clasificaci\u00f3n de los productos no destinados a uso m\u00e9dico, mientras que el anexo 1 enumera los productos no destinados a uso m\u00e9dico para los que tambi\u00e9n ser\u00e1 obligatoria para Suiza la aplicaci\u00f3n de las especificaciones comunes establecidas en el Reglamento de Ejecuci\u00f3n (UE) 2022\/2346 y en el Reglamento de Ejecuci\u00f3n (UE) 2022\/2347 de la Comisi\u00f3n Europea.<\/p>\n<p>&nbsp;<\/p>\n<p>Con respecto a la ampliaci\u00f3n de los plazos transitorios para los productos sanitarios y los productos sanitarios para diagn\u00f3stico in vitro adoptada en la UE el 20 de marzo, el Consejo Federal Suizo aplic\u00f3 el Reglamento de Ejecuci\u00f3n (UE) 2023\/1194 concediendo la ampliaci\u00f3n hasta el 31 de diciembre de 2027 o 2028 dependiendo de la clase de riesgo del producto tambi\u00e9n a los productos sin finalidad m\u00e9dica.<\/p>\n<p>&nbsp;<\/p>\n<p>&gt;&gt; Si desea comercializar productos sanitarios y productos sanitarios para diagn\u00f3stico in vitro o productos sin finalidad m\u00e9dica en Suiza, Thema puede ayudarle con el servicio de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>Consultor\u00eda estrat\u00e9gica-regulatoria<\/strong><\/a> para la definici\u00f3n de la clasificaci\u00f3n y para comprobar la conformidad del producto (incluido el etiquetado) y la documentaci\u00f3n del sistema, actuando como\u00a0 <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\/\"><strong>Representante Suizo Autorizado (CH REP)<\/strong><\/a> y proporcionando apoyo en el\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/supporto-alla-certificazione-ce-dispositivi-medici-ivd\/\"><strong>registro<\/strong><\/a> de productos en Swissmedic.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Fuente<\/strong>:<\/p>\n<p><a href=\"https:\/\/fedlex.data.admin.ch\/filestore\/fedlex.data.admin.ch\/eli\/cc\/2001\/422\/20130101\/it\/pdf-a\/fedlex-data-admin-ch-eli-cc-2001-422-20130101-it-pdf-a.pdf\"><em>Legge federale sui medicamenti e i dispositivi medici<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 29 de septiembre de 2023, el Consejo Federal Suizo modific\u00f3 la Ordenanza de Productos Sanitarios para mejorar la seguridad de  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":30914,"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-30918","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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