{"id":2401,"date":"2022-03-15T13:36:41","date_gmt":"2022-03-15T18:36:41","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=2401"},"modified":"2022-11-03T15:39:50","modified_gmt":"2022-11-03T20:39:50","slug":"switzerland-updates-registration-requirements","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/switzerland-updates-registration-requirements\/","title":{"rendered":"Swissmedic Updates Registration Guidance &#038; Announces New &#8220;Swiss EUDAMED&#8221;"},"content":{"rendered":"<p>[vc_row][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_empty_space height=&#8221;22px&#8221;][vc_column_text]<span style=\"color: #333333;\"><span class=\"tooltip tooltip-txt\" data-tooltip=\"Swissmedic is the competent authority in Switzerland, overseeing medical devices and IVDs.\" data-position=\"top\">Swissmedic<\/span>\n published additional updates regarding the Swiss Single Registration Number (CHRN) and device registration requirements.\u00a0\u00a0<\/span><\/p>\n<h4><span style=\"color: #101b29;\"><b>Quick Refresher<\/b>\u00a0<\/span><\/h4>\n<p><span style=\"color: #333333;\">The Swiss Single Registration Number (CHRN) is comparable to the European Single Registration Number (SRN). After the Mutual Recognition Agreement <span class=\"tooltip tooltip-txt\" data-tooltip=\"Agreement between Switzerland and the EU allowing for free movement of goods between the two markets. The current agreement refers to the old Directives. The MDR\/IVDR are not covered, i.e., after the dates of application for each regulation, the MRA is no longer valid. An updated or new agreement is needed to continue the free movement of goods. \" data-position=\"top\">(MRA)<\/span>\n for medical devices lapsed on 26 May 2021, Switzerland\u2019s access to <span class=\"tooltip tooltip-txt\" data-tooltip=\"EUDAMED is the European Database on Medical Devices. This central databank will house manufacturer, authorized representative and importer details. It will also house details about medical devices on the market, clinical investigations, vigilance and more.\" data-position=\"top\">EUDAMED<\/span>\n was removed. Therefore, Switzerland had to quickly find an alternate, equivalent system to identify Swiss Authorized Representatives, manufacturers and importers. \u00a0<\/span><\/p>\n<p><span style=\"color: #333333;\">CHRNs are only required for Swiss entities, i.e., non-Swiss manufacturers do not need to obtain a CHRN, but their Swiss Authorized Representatives and Importers must obtain one.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"color: #333333;\">Switzerland is also in the process of addressing the device registration gap, now that they no longer have Competent Authority level access to EUDAMED.\u00a0\u00a0<\/span><\/p>\n<h4><span style=\"color: #101b29;\"><b>The Update \u2013 Swiss Single Registration Number<\/b>\u00a0\u00a0\u00a0<\/span><\/h4>\n<p><span data-contrast=\"auto\"><span style=\"color: #333333;\">Swissmedic updated its Information Sheet<\/span> \u2018<\/span><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/registriernummer-chrn.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Unique Identification Number \u2013 CHRN<\/span><\/a><span data-contrast=\"auto\">\u2019<span style=\"color: #333333;\">, publishing a revised version on 1 March 2022. While it doesn\u2019t appear much has changed, the document outlines the information in a clearer way.<\/span><\/span><span style=\"color: #333333;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span style=\"color: #333333;\">CHRNs are required for Swiss-based Manufacturers, Authorized Representatives and Importers only; Distributors do not require a CHRN\u00a0<\/span><\/li>\n<li><span style=\"color: #333333;\">Steps to submit a CHRN application\u00a0<\/span><\/li>\n<li><span style=\"color: #333333;\">How to submit change notifications; Specifies that changes must be notified to Swissmedic within one week\u00a0<\/span><\/li>\n<li><span style=\"color: #333333;\">CHRN application fee: \u201c<i>Experience has shown that issuing the CHRN requires one hour of work, which therefore generally corresponds to a fee of CHF 200.<\/i>\u201d\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"color: #333333;\">CHRN requests must be made within three months of first placing a device onto the market and Swissmedic will issue the CHRN within 30 days.\u00a0\u00a0<\/span><\/p>\n<h4><span style=\"color: #101b29;\"><strong>The Update \u2013 Swiss Device Registration Database (&#8220;Swiss EUDAMED&#8221;)<\/strong><\/span><\/h4>\n<p><span style=\"color: #333333;\">Swissmedic advised the EUDAMED-like requirements for medical device registration are forthcoming, and that they are in the process of designing the database.<\/span><\/p>\n<p><span data-contrast=\"auto\"><span style=\"color: #333333;\">Swissmedic updated their medical device database\u2019<\/span>s <\/span><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank.html\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">webpage<\/span><\/a><span style=\"color: #333333;\"> to state that they \u201c<i>will communicate a schedule for the introduction of the medical devices database by the middle of this year<\/i>.\u201d <\/span><\/p>\n<p><span style=\"color: #333333;\">Further, that the new database will be similar to EUDAMED, \u201c<i>due to continuing aim of equivalence between regulation in Switzerland and the EU<\/i>.\u201d\u00a0<\/span><\/p>\n<p><span style=\"color: #333333;\"> Fortunately, economic operators (i.e., Swiss-bsaed manufacturers, authorized representatives and importers) do not need to re-register once the new system goes live. Swissmedic will migrate the data.\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><span style=\"color: #333333;\">In the meantime, industry should follow the current<\/span> <a href=\"https:\/\/casusconsulting.com\/services\/switzerland\/device-registration\/\" target=\"_blank\" rel=\"noopener\">Swiss registration requirements<\/a>.<\/span><\/p>\n<h4><span style=\"color: #101b29;\"><b>The Future<\/b>\u00a0<\/span><\/h4>\n<p><span style=\"color: #333333;\">The Information Sheet and Swissmedic website continue to indicate their longer-term intent to resolve the discontinuation of the MRA. The Information Sheet states the following, indicating they view the above as temporary measures:\u00a0\u00a0<\/span><\/p>\n<p><span style=\"color: #333333;\">\u201c<b><i>Until the MRA (Mutual Recognition Agreement) is updated,<\/i><\/b><i> Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland.<\/i>\u201d\u00a0<\/span><\/p>\n<p><span style=\"color: #333333;\" data-contrast=\"auto\">Pending the Swiss Federal Council and the EU Commission coming to terms and recreating the Single Market for medical devices, manufacturers must continue to comply with Switzerland\u2019s new requirements. This includes appointing a Swiss Authorized Representative if not located in Switzerland, as well as other requirements put into place to address the lapsed MRA.<\/span>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/6&#8243;][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Swissmedic published additional updates regarding the Swiss Single Registration Number (CHRN) and device registration requirements.\u00a0\u00a0Quick Refresher &#8211; The Swiss Single &#8230;<\/p>\n","protected":false},"author":1,"featured_media":2411,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[4],"tags":[56,9],"cp_meta_data":{"_edit_lock":["1654897776:4"],"_edit_last":["4"],"_wp_page_template":["default"],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-template":["intro"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-post-hide-image":["0"],"jbp-single-post":["a:3:{s:8:\"override\";s:1:\"0\";s:22:\"single_template_custom\";s:1:\"0\";s:5:\"nonce\";s:10:\"9143121d50\";}"],"_wpb_vc_js_status":["true"],"_thumbnail_id":["2411"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-meta-seo-title":["New Swiss 'EUDAMED-like' System Being Created"],"mfn-meta-seo-description":["Swissmedic published an update on medical device and economic operator registration requirements, including creation of a EUDAMED-like database. 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