{"id":20268,"date":"2022-03-14T12:17:42","date_gmt":"2022-03-14T11:17:42","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=20268"},"modified":"2023-06-23T12:11:30","modified_gmt":"2023-06-23T10:11:30","slug":"representante-autorizado-suizo","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/representante-autorizado-suizo\/","title":{"rendered":"REPRESENTANTE AUTORIZADO SUIZO"},"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\"><\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" width=\"1024\" height=\"536\" class=\"wp-image-20271\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-1024x536.jpg\" alt=\"representante-autorizado suizo ch rep thema\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-200x105.jpg 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-300x157.jpg 300w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-400x209.jpg 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-600x314.jpg 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-768x402.jpg 768w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-800x419.jpg 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema-1024x536.jpg 1024w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/representante-autorizado-suizo-ch-rep-thema.jpg 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption>Servicio de Representante Autorizado Suizo<\/figcaption><\/figure>\n<\/div>\n<\/p>\n<p>Eres un <strong>Fabricante con sede fuera del territorio suizo<\/strong> y quieres <strong>comercializar<\/strong> <strong>tus Dispositivos M\u00e9dicos en Suiza<\/strong>?<\/p>\n<\/p>\n<p>A partir <strong>del 26 de mayo 2021<\/strong>, con plena aplicaci\u00f3n del <strong>MDR (UE) 2017\/745<\/strong> y en ausencia de acuerdo istitucional, <strong>Suiza<\/strong> se considera oficialmente un <strong>\u201cTercer pa\u00eds\u201d para Europa.<\/strong><\/p>\n<\/p>\n<p><strong>\u00bfCu\u00e1l es el plazo l\u00edmite de nominaci\u00f3n del Representante Autorizado Suizo?<\/strong><\/p>\n<\/p>\n<p>El Art. 104 del MedDo prev\u00e9 los seguintes per\u00edodos transitorios para la nominaci\u00f3n de un Representante Autorizado Suizo:<\/p>\n<\/p>\n<ul class=\"wp-block-list\">\n<li><strong>31 de diciembre de 2021<\/strong> para los productos de la clase III, los productos implantables de la clase IIb y los productos m\u00e9dicos implantables activos;<\/li>\n<li><strong>31 de marzo de 2022<\/strong> para los productos no implantables de clase IIb y de los productos de la clase IIa;<\/li>\n<li><strong>31 de julio de 2022<\/strong> para los productos de la clase I.<\/li>\n<\/ul>\n<\/p>\n<p>Para los sistemas e Kit de procedimiento, es necesario nombrar un Representante Autorizado Suizo antes del <strong>31 de julio de 2022<\/strong> (Art.51 p\u00e1rrafo 5).<\/p>\n<\/p>\n<p><strong>Thema proporciona el servicio de Representante Autorizado Suizo en conformidad de la reglamentaci\u00f3n suiza.<\/strong><\/p>\n<\/p>\n<p>C\u00f3mo Representante Autorizado Suizo (CH REP), Thema tiene que:<\/p>\n<\/p>\n<ul class=\"wp-block-list\">\n<li>Cumplir las obligaciones de comunicaci\u00f3n con la Autoridad Reguladora Swissmedic.<\/li>\n<li>Actuar en el caso de medidas correctoras en el campo y acontecimientos adversos.<\/li>\n<li>Cumplir sus obligaciones establecidas de supervisi\u00f3n posventa.<\/li>\n<li>Registrar los dispositivos en la base de datos Swissmedic respectado los ls plazos previstos.<\/li>\n<\/ul>\n<\/p>\n<p>Thema garantiza el respecto de las obligaciones contra\u00eddas gracias a una organizazi\u00f3n por procesos seg\u00fan la <strong>norma ISO 13485.<\/strong><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/08\/CH-REP_ES.pdf\" target=\"_blank\" rel=\"noopener\">Ir a la pagina CH REP<\/a><\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background 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-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-padding-bottom:20px;--awb-padding-right-small:20px;--awb-padding-left-small:20px;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:10px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);\"><p>Para m\u00e1s informaci\u00f3n y para solicitar el servicio de Representante Autorizado Suizo<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_accent_color:#ffffff;--button_accent_hover_color:var(--awb-custom12);--button_border_hover_color:var(--awb-color1);--button-border-radius-top-left:10px;--button-border-radius-top-right:10px;--button-border-radius-bottom-right:10px;--button-border-radius-bottom-left:10px;--button_gradient_top_color:var(--awb-custom12);--button_gradient_bottom_color:var(--awb-custom12);--button_gradient_top_color_hover:var(--awb-color1);--button_gradient_bottom_color_hover:var(--awb-color1);--button_text_transform:var(--awb-typography4-text-transform);--button_font_size:var(--awb-typography4-font-size);--button_line_height:var(--awb-typography4-line-height);--button_typography-letter-spacing:var(--awb-typography4-letter-spacing);--button_typography-font-family:&quot;Montserrat&quot;;--button_typography-font-style:normal;--button_typography-font-weight:700;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/es\/contactanos\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">CONT\u00c1CTANOS<\/span><\/a><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":7095,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-20268","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Representante Autorizado Suizo CH REP servicio Thema<\/title>\n<meta name=\"description\" content=\"Thema proporciona el servicio de Representante Autorizado Suizo en conformidad de la reglamentaci\u00f3n suiza.\ufeff \u00a1Descubre el servicio!\" \/>\n<meta name=\"robots\" content=\"index, follow, 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