{"id":5292,"date":"2026-06-01T10:52:14","date_gmt":"2026-06-01T10:52:14","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=5292"},"modified":"2026-07-27T11:13:31","modified_gmt":"2026-07-27T11:13:31","slug":"swissmedic-announces-medical-device-registration-fees-for-swissdamed","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/swissmedic-announces-medical-device-registration-fees-for-swissdamed\/","title":{"rendered":"Swissmedic Announces Medical Device Registration Fees for Swissdamed"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 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:1248px;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:20px;--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-1\"><p>Swissmedic has published further details on the registration fees that will apply to medical devices, systems and procedure packs registered in the swissdamed database ahead of\u00a0<b>the mandatory registration requirements coming into force on 1 July 2026.<\/b><\/p>\n<p>According to the authority, all devices, systems and procedure packs placed on the Swiss market from that date must be registered in the UDI Devices module of swissdamed,\u00a0<b>with a transitional period remaining in place until 31 December 2026.<\/b><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/swissmedic-announces-medical-device-registration-fees-for-swissdamed\/#Registration_Fee_Structure\" >Registration Fee Structure<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/swissmedic-announces-medical-device-registration-fees-for-swissdamed\/#When_do_the_fees_first_become_payable\" >When do the fees first become payable?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/swissmedic-announces-medical-device-registration-fees-for-swissdamed\/#Invoicing\" >Invoicing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/swissmedic-announces-medical-device-registration-fees-for-swissdamed\/#Key_Points_for_Manufacturers\" >Key Points for Manufacturers<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/swissmedic-announces-medical-device-registration-fees-for-swissdamed\/#Prepare_for_swissdamed_Now\" >Prepare for swissdamed Now<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Registration_Fee_Structure\"><\/span>Registration Fee Structure<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Swissmedic has confirmed the following\u00a0<u>fee model for device registration<\/u>:<\/p>\n<ul>\n<li>CHF 200 for the first device per year and CHF 20 for each additional device<\/li>\n<li>A maximum of CHF 10,000 per year per manufacturer \/ person who assembles systems or procedure packs (no additional costs for 492 devices or more per year)<\/li>\n<\/ul>\n<h2 class=\"fusion-responsive-typography-calculated\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"When_do_the_fees_first_become_payable\"><\/span>When do the fees first become payable?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Swissmedic highlighted several important considerations for economic operators:<\/p>\n<ul>\n<li>On 31.12.2026 for all UDI-DIs with the status &#8216;On the market&#8217;<\/li>\n<li>No fee if the device is marked as &#8216;No longer placed on the market&#8217; as at 31.12.2026<\/li>\n<\/ul>\n<p>The registration requirement applies to\u00a0<strong>all products sold in Switzerland.<\/strong><\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Invoicing\"><\/span>Invoicing<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Key information on fee payment and invoicing timelines has now been confirmed by Swissmedic.<\/p>\n<ul>\n<li>First invoice for devices registered up to 31 December 2026 will be issued in January 2027<\/li>\n<li>Followed by regular invoicing for new registrations<\/li>\n<li>New calendar year = new fee calculation<\/li>\n<\/ul>\n<h2 class=\"fusion-responsive-typography-calculated\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Key_Points_for_Manufacturers\"><\/span>Key Points for Manufacturers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Swissmedic highlighted several important considerations for economic operators:<\/p>\n<ul>\n<li>Fees are charged per manufacturer or person assembling systems and procedure packs<\/li>\n<li>Updates to existing device data are free of charge<\/li>\n<li>A fee is payable for the new registration of a device that was \u201cdiscarded\u201d<\/li>\n<\/ul>\n<h2 class=\"\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Prepare_for_swissdamed_Now\"><\/span>Prepare for swissdamed Now<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><i>With mandatory registration starting on 1 July 2026 and the transition period ending on 31 December 2026, medical device companies should begin preparing their registration strategy, reviewing device portfolios and ensuring their data is ready for compliance.Need support with medical device registration in Switzerland? Contact our experts to ensure a smooth and compliant registration process.<\/i><\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-swissdamed-registration\/\"><span class=\"fusion-button-text\">Button TextStart Your swissdamed Registration Now<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-margin-top:50px;--awb-max-width:800px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1000\" height=\"390\" title=\"footer cross &#8211; 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