{"id":1446,"date":"2023-06-02T15:02:24","date_gmt":"2023-06-02T13:02:24","guid":{"rendered":"https:\/\/tradee.ch\/blog\/rechtliche-anforderungen-an-schweizer-importeure\/"},"modified":"2023-07-10T10:14:42","modified_gmt":"2023-07-10T08:14:42","slug":"legal-requirements-for-swiss-importers","status":"publish","type":"post","link":"https:\/\/tradee.yelpix.net\/en\/blog\/legal-requirements-for-swiss-importers\/","title":{"rendered":"Legal requirements for Swiss importers"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1446\" class=\"elementor elementor-1446\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4710f1b e-flex e-con-boxed e-con e-parent\" data-id=\"4710f1b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b98fba8 e-con-full e-flex e-con e-parent\" data-id=\"b98fba8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-14f9f41 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-text-editor\" data-id=\"14f9f41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><b>Are you unsure what requirements you need to meet as an importer? Here you can get all the information.  <\/b><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ebb695 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"8ebb695\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f786c8 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"8f786c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t1\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">General requirements<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t2\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Quality management system <\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t3\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Regulations as importer<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#t4\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">More information<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b102b35 e-con-full e-flex e-con e-parent\" data-id=\"b102b35\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c781b5 elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"5c781b5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><b>Are you unsure what requirements you need to meet as an importer? Here you can get all the information.  <\/b><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3bf6aee elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3bf6aee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-efe07c7 elementor-widget elementor-widget-heading\" data-id=\"efe07c7\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t1\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">General requirements<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aac4d35 elementor-widget elementor-widget-text-editor\" data-id=\"aac4d35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As an importer of medical devices in Switzerland, you must comply with the applicable legal guidelines and requirements. The most important regulations include the Medical Devices Ordinance (MPV) and the Ordinance on the Recording, Assessment and Compensation of Damages in Connection with Medical Devices (MepV). In addition, you must ensure that the products you import meet the<\/span> <b> CE marking <\/b><span style=\"font-weight: 400;\">and comply with the relevant European standards and directives.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d32ae2 elementor-widget elementor-widget-heading\" data-id=\"3d32ae2\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t2\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Quality management system<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7142e75 elementor-widget elementor-widget-text-editor\" data-id=\"7142e75\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As an importer, you are also required to implement a <\/span><b>quality management system<\/b><span style=\"font-weight: 400;\">  implement and maintain a system that ensures that the products you import comply with applicable requirements. In addition, you need to make sure you have adequate liability insurance to cover any potential damages.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It is also important to note that as an importer, you are responsible for the <\/span><b>safety of the products <\/b> <span style=\"font-weight: 400;\">responsible for the products you bring to the Swiss market. If a medical device you import has a safety problem, you are required to report it to the authorities immediately and take appropriate action to correct the problem.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Overall, as an importer of medical devices in Switzerland, you must ensure that you comply with applicable regulations and requirements to ensure that the products you import are safe and effective and meet the requirements of the Swiss regulatory authorities.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ab2ef4 elementor-widget elementor-widget-heading\" data-id=\"1ab2ef4\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t3\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Regulations as importer<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59925fc elementor-widget elementor-widget-text-editor\" data-id=\"59925fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In order to operate as an importer of medical devices in Switzerland, various regulations and requirements must be met. These include:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Registration with the Swiss Agency for Therapeutic Products Swissmedic as an importer of medical devices.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Compliance with the requirements of the Swiss Medical Devices Ordinance (MepV) and the European Medical Devices Regulation (MDR).<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Ensure compliance of imported medical devices with MepV and MDR requirements.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Documenting the compliance of imported medical devices and conducting risk assessments.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Compliance with the requirements for handling personal data in the context of import activities.<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-258d944 elementor-widget elementor-widget-image\" data-id=\"258d944\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"688\" height=\"456\" src=\"https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Rechtliche-Anforderungen-an-Schweizer-Importeure2-2.png\" class=\"attachment-large size-large wp-image-1489\" alt=\"\" srcset=\"https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Rechtliche-Anforderungen-an-Schweizer-Importeure2-2.png 688w, https:\/\/tradee.yelpix.net\/wp-content\/uploads\/2023\/06\/Rechtliche-Anforderungen-an-Schweizer-Importeure2-2-300x199.png 300w\" sizes=\"(max-width: 688px) 100vw, 688px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0be7a8 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c0be7a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed72910 elementor-widget elementor-widget-text-editor\" data-id=\"ed72910\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>  <span style=\"font-weight: 400;\">Overview of the requirements to be met as an importer.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-198daab elementor-widget elementor-widget-heading\" data-id=\"198daab\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"t4\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">More information<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8143bf4 elementor-widget elementor-widget-text-editor\" data-id=\"8143bf4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In addition, depending on the type and intended use of the imported medical devices, further regulations and requirements may arise, for example with regard to the safety and efficacy of the products. It is therefore important to obtain in-depth information on the applicable regulations and requirements before engaging in import activities, and to consult external experts if necessary.<\/span><\/p><p><span style=\"font-weight: 400;\">Do you have further questions about the applicable regulations and requirements? tradee.ch is your competent partner for regulatory and quality assurance matters in the area of direct and parallel import with a focus on the Swiss market&#8230;. Our team is at your side to support you in complying with the applicable regulations efficiently and reliably<\/span><\/p><p><span style=\"font-weight: 400;\">You can also find more information about the specifications and requirements of direct import here: <\/span><a href=\"https:\/\/tradee.yelpix.net\/en\/blog\/what-are-the-obligations-of-a-swiss-importer\/\"><br \/><span style=\"font-weight: 400;\">What are the obligations of a Swiss importer?<\/span><br \/><br \/><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Are you unsure what requirements you need to meet as an importer? Here you can get all the information. General requirements Quality management system Regulations as importer More information Are you unsure what requirements you need to meet as an importer? Here you can get all the information. General requirements As an importer of medical [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1032,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25,28],"tags":[],"class_list":["post-1446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-import","category-legal"],"acf":[],"_links":{"self":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/posts\/1446","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/comments?post=1446"}],"version-history":[{"count":0,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/posts\/1446\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/media\/1032"}],"wp:attachment":[{"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/media?parent=1446"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/categories?post=1446"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tradee.yelpix.net\/en\/wp-json\/wp\/v2\/tags?post=1446"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}