{"id":18733,"date":"2022-03-14T12:17:42","date_gmt":"2022-03-14T11:17:42","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=18733"},"modified":"2023-06-23T12:09:14","modified_gmt":"2023-06-23T10:09:14","slug":"swiss-authorised-representative-service","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/swiss-authorised-representative-service\/","title":{"rendered":"Swiss Authorised Representative"},"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\" class=\"wp-image-18734\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/08\/swiss-authorised-representative-service-1024x536.jpg\" alt=\"Swiss Authorised Representative Thema service\"><figcaption>Swiss Authorised Representative Service<\/figcaption><\/figure>\n<\/div>\n<\/p>\n<p>Are you a <strong>Manufacturer domiciled outside of Switzerland <\/strong>and wanting to <strong>market your Medical Devices in Switzerland<\/strong>?<\/p>\n<\/p>\n<p><strong>Since 26 May 2021<\/strong>, with the full application of the <strong>MDR (EU) 2017\/745 <\/strong>and having not reached an institutional agreement, <strong>Switzerland<\/strong> is officially considered a <strong>\u201cThird Country\u201d for Europe<\/strong>.<\/p>\n<\/p>\n<p><strong>What is the timetable for appointing a Swiss AR?<\/strong><\/p>\n<\/p>\n<p><strong>Art. 104<\/strong> of <strong>MedDo<\/strong> outlines the following <strong>transition periods<\/strong> for the appointment of a Swiss Authorised Representative:<\/p>\n<\/p>\n<ul class=\"wp-block-list\">\n<li>by <strong>31 December 2021 <\/strong>for class III devices, class IIb implantable devices and active implantable devices;<\/li>\n<li>by <strong>31 March 2022 <\/strong>for non-implantable class IIb devices and class lla devices;<\/li>\n<li>by <strong>31 July 2022 <\/strong>for class I devices.<\/li>\n<\/ul>\n<\/p>\n<p>For systems and procedure packs, a Swiss AR must be appointed by 31 July 2022 (Art. 51 paragraph 5).<\/p>\n<\/p>\n<p><strong>Thema is able to carry out the service of Swiss Authorised Representative in full compliance with the Swiss regulation. <\/strong><\/p>\n<\/p>\n<p>As Swiss Authorised Representative (CH REP), <strong>Thema is in charge <\/strong>of:<\/p>\n<\/p>\n<ul class=\"wp-block-list\">\n<li>Fulfilling reporting obligations to the Regulatory Authority Swissmedic.<\/li>\n<li>Taking action in case of field corrective actions and adverse events.<\/li>\n<li>Ensuring compliance with post-market surveillance obligations.<\/li>\n<li>Registering the devices on the Swissmedic database within the prescribed time.<\/li>\n<\/ul>\n<\/p>\n<p>Thema assures <strong>compliance with the assigned obligations<\/strong> through a process-managed corporate structure according to <strong>ISO 13485 Standard<\/strong>.<\/p>\n<\/p>\n<p><strong>Download <\/strong><a href=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/CH-REP_EN.pdf\" target=\"_blank\" rel=\"noopener\"><strong>CH REP service document<\/strong><\/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><span style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); font-weight: var(--awb-text-font-weight); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\">For further details and to request <\/span>our Swiss Authorised Representative service<\/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\/en\/contact-us-2\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">CONTACT US<\/span><\/a><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":7094,"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-18733","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>Swiss Authorised Representative Thema service CH REP<\/title>\n<meta name=\"description\" content=\"Thema provides the service of Swiss Authorised Representative in full compliance with Swiss regulations. 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