{"id":5698,"date":"2025-09-15T08:30:00","date_gmt":"2025-09-15T08:30:00","guid":{"rendered":"https:\/\/pharmanomos.ch\/swissmedic-regulatory-news-2025-guidance-for-pharmacies-importers-and-wholesalers\/"},"modified":"2026-04-28T06:07:02","modified_gmt":"2026-04-28T06:07:02","slug":"swissmedic-regulatory-news-2025-guidance-for-pharmacies-importers-and-wholesalers","status":"publish","type":"post","link":"https:\/\/pharmanomos.ch\/en\/swissmedic-regulatory-news-2025-guidance-for-pharmacies-importers-and-wholesalers\/","title":{"rendered":"Swissmedic Regulatory News 2025: Guidance for Pharmacies, Importers and Wholesalers"},"content":{"rendered":"\n<h2 class=\"wp-block-heading has-large-font-size\">Swissdamed &#8211; UDI Devices Module<\/h2>\n\n<p class=\"has-medium-font-size\">As of <strong>Aug. 18, 2025<\/strong>, Swissmedic activated the <strong>UDI Devices<\/strong> module in the <strong>Swissdamed<\/strong> database, allowing voluntary registration of medical devices, IVDs, and kit\/process packs (SPPs).<br\/>From <strong>July 1, 2026<\/strong>, however, registration will become <strong>mandatory for all products placed on the Swiss market.<\/strong><br\/>There is also a short transition period until <strong>December 31, 2026<\/strong> <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/swissdamed-informationen\/registrierung-mepprodukte-moeglich.html?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\">swissmedic.ch+2swissmedic.ch+2<\/a>.<br\/><strong>Important<\/strong>: If a product is involved in a &#8220;Field Safety Corrective Action&#8221; (FSCA), there <strong>is no transition<\/strong>: registration is immediate from July 1, 2026<\/p>\n\n<p class=\"has-small-font-size\">For more info:<\/p>\n\n<ul class=\"wp-block-list link-verde has-small-font-size\">\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/swissdamed-informationen\/registrierung-mepprodukte-moeglich.html\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/swissdamed-informationen\/registrierung-mepprodukte-moeglich.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/produktregistrierung.html\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/produktregistrierung.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/faq.html\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/faq.html<\/a><\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading has-large-font-size\">eIFU (Electronic Operating Instructions)<\/h2>\n\n<p class=\"has-medium-font-size\">On <strong>Aug. 8, 2025<\/strong>, Swissmedic implemented EU Regulation 2025\/1234, extending the use of <strong>electronic instructions<\/strong> for use<em>(eIFUs<\/em>) to Switzerland as well, as long as they are intended for professionals.<br\/><strong>Instructions for use intended for the general public<\/strong> (e.g., patients) must remain in paper form.<br\/>The link to eIFUs must be registered in the UDI database.<\/p>\n\n<p class=\"has-small-font-size\">For more info:<\/p>\n\n<ul class=\"wp-block-list link-verde has-small-font-size\">\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/anwendbare-rechtsakte-gemaess-eu-mdr\/umsetzung-eu-durchfuehrungsverordnung-gebrauchsanweisungen.html?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/anwendbare-rechtsakte-gemaess-eu-mdr\/umsetzung-eu-durchfuehrungsverordnung-gebrauchsanweisungen.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medenvoyglobal.com\/blog\/new-eu-regulation-on-eifus-adopted-by-swissmedic\/\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/medenvoyglobal.com\/blog\/new-eu-regulation-on-eifus-adopted-by-swissmedic\/<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.swiss-medtech.ch\/en\/news\/eifu-regulation-switzerland\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swiss-medtech.ch\/en\/news\/eifu-regulation-switzerland<\/a><\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading has-large-font-size\"><strong>Traceability System (Swissdamed &#8211; Actor &amp; Device Registration)<\/strong><\/h2>\n\n<p class=\"has-medium-font-size\">The Swissdamed system consists of two main parts:<\/p>\n\n<ul class=\"wp-block-list has-medium-font-size\">\n<li class=\"has-medium-font-size\"><strong>Actors Module<\/strong> (active from August 2024): register of economic operators (manufacturers, authorized representatives, assemblers).<\/li>\n\n\n\n<li><strong>UDI Devices Module<\/strong> (activated from August 2025): register of devices and IVDs intended for the Swiss market.<\/li>\n<\/ul>\n\n<p class=\"has-medium-font-size\">You are prompted to create the <strong>economic profile<\/strong> (Actor) before starting device registration.<\/p>\n\n<p class=\"has-small-font-size\">For more info:<\/p>\n\n<ul class=\"wp-block-list link-verde has-small-font-size\">\n<li><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medenvoyglobal.com\/blog\/swissmedic-rolls-out-new-swissdamed-udi-devices-module\/\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/medenvoyglobal.com\/blog\/swissmedic-rolls-out-new-swissdamed-udi-devices-module\/<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/cmcmedicaldevices.com\/swissdamed-udi-devices-module-medical-device-registration-now-available\/\" target=\"_blank\" rel=\"noopener\" title=\"\">https:\/\/cmcmedicaldevices.com\/swissdamed-udi-devices-module-medical-device-registration-now-available\/<\/a><\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Guidelines for SPP &#8211; Systems and Procedure Packs.<\/h2>\n\n<p class=\"has-medium-font-size\">An information document was published in <strong>2025<\/strong> aligning Swiss regulations with EU regulations (MDR\/IVDR) for <strong>SPPs<\/strong>. Those assembling and marketing these products are required to register within <strong>3 months<\/strong> of first placing on the market. The obligation also includes <strong>post-market surveillance<\/strong>.  <a href=\"https:\/\/www.pureglobal.com\/news\/swissmedic-2025-guidance-on-systems-and-procedure-packs?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/p>\n\n<p class=\"has-small-font-size\">For more info:<\/p>\n\n<ul class=\"wp-block-list has-small-font-size\">\n<li class=\"link-verde\"><a href=\"https:\/\/www.pureglobal.com\/news\/swissmedic-2025-guidance-on-systems-and-procedure-packs\">https:\/\/www.pureglobal.com\/news\/swissmedic-2025-guidance-on-systems-and-procedure-packs<\/a><\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Operational Summary (Table)<\/h2>\n\n<figure class=\"wp-block-table link-verde\"><table class=\"has-fixed-layout\"><thead><tr><th class=\"has-text-align-left\" data-align=\"left\">Theme<\/th><th class=\"has-text-align-left\" data-align=\"left\">Key Expiration<\/th><th class=\"has-text-align-left\" data-align=\"left\">Obligated<\/th><th class=\"has-text-align-left\" data-align=\"left\">Official links<\/th><\/tr><\/thead><tbody><tr><td class=\"has-text-align-left\" data-align=\"left\">UDI Devices (Swissdamed)<\/td><td class=\"has-text-align-left\" data-align=\"left\">Mandatory as of 1\/7\/2026<\/td><td class=\"has-text-align-left\" data-align=\"left\">Manufacturers, representatives, assemblers<br\/><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/swissdamed-informationen\/registrierung-mepprodukte-moeglich.html?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/td><td class=\"has-text-align-left\" data-align=\"left\"><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/swissdamed-informationen\/registrierung-mepprodukte-moeglich.html\" target=\"_blank\" rel=\"noopener\" title=\"Link 1\">Link 1<\/a> and <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html\" target=\"_blank\" rel=\"noopener\" title=\"link 2\">link 2<\/a><\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">eIFU (electronic)<\/td><td class=\"has-text-align-left\" data-align=\"left\">Active as of 8\/8\/2025<\/td><td class=\"has-text-align-left\" data-align=\"left\">Manufacturers to be included UDI URL<br\/><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/anwendbare-rechtsakte-gemaess-eu-mdr\/umsetzung-eu-durchfuehrungsverordnung-gebrauchsanweisungen.html?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/td><td class=\"has-text-align-left\" data-align=\"left\"><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/anwendbare-rechtsakte-gemaess-eu-mdr\/umsetzung-eu-durchfuehrungsverordnung-gebrauchsanweisungen.html\" target=\"_blank\" rel=\"noopener\" title=\"Link 1\">Link 1<\/a> and <a href=\"https:\/\/medenvoyglobal.com\/blog\/new-eu-regulation-on-eifus-adopted-by-swissmedic\/\" target=\"_blank\" rel=\"noopener\" title=\"\">link 2<\/a><\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">SPP<\/td><td class=\"has-text-align-left\" data-align=\"left\">Registration within 3 months<\/td><td class=\"has-text-align-left\" data-align=\"left\">SPP Assemblers<br\/><a href=\"https:\/\/www.pureglobal.com\/news\/swissmedic-2025-guidance-on-systems-and-procedure-packs?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/td><td class=\"has-text-align-left\" data-align=\"left\"><a href=\"https:\/\/www.pureglobal.com\/news\/swissmedic-2025-guidance-on-systems-and-procedure-packs\" target=\"_blank\" rel=\"noopener\" title=\"\">Link 1<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Implications for Pharmacies, Importers and Wholesalers<\/h2>\n\n<p class=\"has-medium-font-size\"><strong>Pharmacies<\/strong>: need to apply for registration only if they act as SPP assemblers; otherwise, especially in preparations, it is important to be ready on eIFU and ter compliance.<\/p>\n\n<p class=\"has-medium-font-size\"><strong>Importers<\/strong>: must be registered as &#8220;actor&#8221; in Swissdamed, linked to the imported devices, but cannot register the devices themselves; this is the prerogative of the manufacturer or authorized representative.<\/p>\n\n<p class=\"has-medium-font-size\"><strong>Wholesalers\/Distributors<\/strong>: must ensure traceability and UDI alignment, but registration is left to the lead actor. Use of eIFU and participation in supervision is crucial. <\/p>\n\n<h2 class=\"wp-block-heading has-large-font-size\">Why get help?<\/h2>\n\n<p class=\"has-medium-font-size\">These changes require <strong>proactive planning<\/strong> especially for importers, manufacturers and pharmacies involved in SPP tracking, surveillance or assembly. For technical or operational support, we can align your current procedures to <strong>ensure compliance<\/strong>. <\/p>\n\n<div class=\"wp-block-uagb-buttons uagb-buttons__outer-wrap uagb-btn__default-btn uagb-btn-tablet__default-btn uagb-btn-mobile__default-btn uagb-block-e038fb4f\"><div class=\"uagb-buttons__wrap uagb-buttons-layout-wrap \">\n<div class=\"wp-block-uagb-buttons-child uagb-buttons__outer-wrap uagb-block-80a1dd4c wp-block-button\"><div class=\"uagb-button__wrapper\"><a class=\"uagb-buttons-repeater wp-block-button__link\" aria-label=\"\" href=\"mailto:info@pharmanomos.ch\" rel=\"follow noopener\" target=\"_self\" role=\"button\"><div class=\"uagb-button__link\">Contact Us Now<\/div><\/a><\/div><\/div>\n<\/div><\/div>\n\n<p class=\"has-medium-font-size\"><em><strong>Free consultation!<\/strong><\/em><\/p>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Swissdamed &#8211; UDI Devices Module As of Aug. 18, 2025, Swissmedic activated the UDI Devices module in the Swissdamed database, allowing voluntary registration of medical devices, IVDs, and kit\/process packs (SPPs).From July 1, 2026, however, registration will become mandatory for all products placed on the Swiss market.There is also a short transition period until December [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5174,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5698","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-senza-categoria"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Swissmedic Regulatory News 2025: UDI, eIFU and Swissdamed<\/title>\n<meta name=\"description\" content=\"Guide to Swissmedic 2025 news: UDI registration in Swissdamed, electronic eIFUs, traceability, and obligations for pharmacies and importers .\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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