{"id":8241,"date":"2020-12-29T14:51:46","date_gmt":"2020-12-29T11:51:46","guid":{"rendered":"https:\/\/mr-gate.com\/sfdas-guidance-on-importation-requirements-of-medical-devices-intended-for-demonstration-or-training-purpose-only\/"},"modified":"2023-10-01T23:06:04","modified_gmt":"2023-10-01T20:06:04","slug":"sfdas-guidance-on-importation-requirements-of-medical-devices-intended-for-demonstration-or-training-purpose-only","status":"publish","type":"post","link":"https:\/\/mr-gate.com\/zh-hans\/sfdas-guidance-on-importation-requirements-of-medical-devices-intended-for-demonstration-or-training-purpose-only\/","title":{"rendered":"SFDA&#8217;s Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purpose only."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8241\" class=\"elementor elementor-8241 elementor-5406\">\n\t\t\t\t\t\t\t        <section class=\"elementor-section elementor-top-section elementor-element elementor-element-5fa3dfdc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5fa3dfdc\" data-element_type=\"section\">\n            \n                        <div class=\"elementor-container elementor-column-gap-default \">\n                    <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-480e61e\" data-id=\"480e61e\" data-element_type=\"column\">\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\n                        \t\t<div class=\"elementor-element elementor-element-3b84c951 elementor-widget elementor-widget-text-editor\" data-id=\"3b84c951\" data-element_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\n<div class=\"wp-block-kadence-rowlayout alignfull\">\n<div id=\"kt-layout-id_228ce2-af\" class=\"kt-row-layout-inner kt-row-has-bg kt-layout-id_228ce2-af\">\n<div class=\"kt-row-column-wrap kt-has-1-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_f38315-6e\">\n<div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-rowlayout alignnone\">\n<div id=\"kt-layout-id_6c66e0-d8\" class=\"kt-row-layout-inner kt-layout-id_6c66e0-d8\">\n<div class=\"kt-row-column-wrap kt-has-1-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_97fb67-c7\">\n<div class=\"kt-inside-inner-col\">\n<h4 id=\"kt-adv-heading_af9b0c-4f\" class=\"kt-adv-heading_af9b0c-4f wp-block-kadence-advancedheading\" style=\"text-align: center;\"><a href=\"https:\/\/www.sfda.gov.sa\/en\" target=\"_blank\" rel=\"noopener\">SFDA<\/a> has recently published a Guidance on the requirements of Medical Devices Intended for Demonstration or Training Purpose only; Click <a href=\"https:\/\/sfda.gov.sa\/sites\/default\/files\/2020-12\/MDS-G8En_0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a> to read the official document.<\/h4>\n\n<p class=\"has-text-align-center\">Published on: 27th December, 2020<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-rowlayout alignnone\">\n<div id=\"kt-layout-id_1c6b4e-77\" class=\"kt-row-layout-inner kt-layout-id_1c6b4e-77\">\n<div class=\"kt-row-column-wrap kt-has-3-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_5be84a-98\">\n<div class=\"kt-inside-inner-col\"> <\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_29fa01-c7\">\n<div class=\"kt-inside-inner-col\"> <\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-column inner-column-3 kadence-column_caef82-c5\">\n<div class=\"kt-inside-inner-col\"> <\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-rowlayout alignnone\">\n<div id=\"kt-layout-id_c5f39e-c7\" class=\"kt-row-layout-inner kt-layout-id_c5f39e-c7\">\n<div class=\"kt-row-column-wrap kt-has-3-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_5d88a8-c1\">\n<div class=\"kt-inside-inner-col\"> <\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_504838-8e\">\n<div class=\"kt-inside-inner-col\"> <\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-column inner-column-3 kadence-column_5b230b-c5\">\n<div class=\"kt-inside-inner-col\"> <\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"kt-row-layout-bottom-sep kt-row-sep-type-sltl\"> <\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-rowlayout alignfull\">\n<div id=\"kt-layout-id_08da4d-c5\" class=\"kt-row-layout-inner kt-row-has-bg kt-layout-id_08da4d-c5\">\n<div class=\"kt-row-layout-top-sep kt-row-sep-type-sltl\"> <\/div>\n<div class=\"kt-row-column-wrap kt-has-1-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_c46290-ad\">\n<div class=\"kt-inside-inner-col\">\n<h3 id=\"kt-adv-heading_4e33e5-3b\" class=\"kt-adv-heading_4e33e5-3b wp-block-kadence-advancedheading\" style=\"text-align: center; color: #2b6dfe; letter-spacing: 4px;\"> <\/h3>\n\n<h2 id=\"kt-adv-heading_fe9db7-0b\" class=\"kt-adv-heading_fe9db7-0b wp-block-kadence-advancedheading\" style=\"text-align: center;\">Highlights from this Document<\/h2>\n\n<div class=\"wp-block-kadence-rowlayout alignnone\">\n<div id=\"kt-layout-id_519397-49\" class=\"kt-row-layout-inner kt-layout-id_519397-49\">\n<div class=\"kt-row-column-wrap kt-has-2-columns kt-gutter-narrow kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row kt-custom-first-width-50 kt-custom-second-width-50\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_b4bb58-96\">\n<div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-accordion alignnone\">\n<div class=\"kt-accordion-wrap kt-accordion-wrap kt-accordion-id_474feb-76 kt-accordion-has-4-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width: none;\">\n<div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane_436481-c3\">\n<div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">Purpose<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>This guidance is intended to specify the requirements for obtaining an importation license for medical devices intended for demonstration or training purpose only.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane_266c48-d6\">\n<div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">Scope<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>This document is applicable to:<\/p>\n\n<ul>\n<li><em><a href=\"https:\/\/mr-gate.com\/zh-hans\/service\/services-in-ksa\/\">Medical devices establishments<\/a> wishing to import medical devices intended for demonstration or training purpose only. <\/em><\/li>\n<li><em>Establishments organizing exhibitions and other establishments wishing to import medical devices intended for demonstration and training purpose at exhibitions. <\/em><\/li>\n<\/ul>\n\n<p> <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<p> <\/p>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_fa00c6-87\">\n<div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-accordion alignnone\">\n<div class=\"kt-accordion-wrap kt-accordion-wrap kt-accordion-id_aef34a-67 kt-accordion-has-11-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width: none;\">\n<div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-4 kt-pane_1828c3-b6\">\n<div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">Required Documents<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Page 5 in the guidance states all the required documents needed to obtain approval for demonstration or training purpose only.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane_01f627-99\">\n<div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Annex (1)<\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Application form for Medical Devices intended for Demonstration or Training Purpose Only.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-8 kt-pane_25c373-d8\">\n<div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Annex (2)<\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Attestation for Importers of Medical Devices Intended for Demonstration or Training Purpose only.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"kt-row-layout-bottom-sep kt-row-sep-type-sltl\"> <\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-rowlayout alignfull\">\n<div id=\"kt-layout-id_a7db02-fd\" class=\"kt-row-layout-inner kt-layout-id_a7db02-fd\">\n<div class=\"kt-row-column-wrap kt-has-1-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_20a4ed-c6\">\n<div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-group\">\n<div class=\"wp-block-group__inner-container\">\n<p class=\"has-text-align-center has-medium-font-size\"><strong><em>For any questions, please drop us a message and we will contact you shortly <\/em><\/strong><\/p>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-group\">\n<div class=\"wp-block-group__inner-container\">\n<p class=\"has-text-align-center\"> <\/p>\n\n<div class=\"wp-block-kadence-form kadence-form-_0c2d69-82 kb-form-wrap\"><form class=\"kb-form\" action=\"\" method=\"post\">\n<div class=\"kadence-blocks-form-field kb-field-desk-width-100 kb-input-size-standard\"><label for=\"kb_field__0c2d69-82_0\">Name<\/label><input id=\"kb_field__0c2d69-82_0\" class=\"kb-field kb-text-style-field kb-text-field kb-field-0\" name=\"kb_field_0\" type=\"text\" value=\"\" placeholder=\"\" data-label=\"Name\" data-type=\"text\"><\/div>\n<div class=\"kadence-blocks-form-field kb-form-field-1 kb-field-desk-width-100 kb-input-size-standard\"><label for=\"kb_field__0c2d69-82_1\">Email<span class=\"required\">*<\/span><\/label><input id=\"kb_field__0c2d69-82_1\" class=\"kb-field kb-text-style-field kb-email-field kb-field-1\" name=\"kb_field_1\" type=\"email\" value=\"\" placeholder=\"\" data-label=\"Email\" data-type=\"email\" data-required=\"yes\"><\/div>\n<div class=\"kadence-blocks-form-field kb-form-field-2 kb-field-desk-width-100 kb-input-size-standard\"><label for=\"kb_field__0c2d69-82_2\">Message<span class=\"required\">*<\/span><\/label><textarea id=\"kb_field__0c2d69-82_2\" class=\"kb-field kb-text-style-field kb-textarea-field kb-field-2\" name=\"kb_field_2\" rows=\"4\" placeholder=\"\" data-label=\"Message\" data-type=\"textarea\" data-required=\"yes\"><\/textarea><\/div>\n<\/form><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t            <\/div>\n        <\/div>\n                            <\/div>\n        <\/section>\n        \t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>SFDA has recently published a Guidance on the requireme [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":7525,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[183],"tags":[173,181,174,175,176,171,172],"class_list":["post-8241","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sfda-regulations-zh-hans","tag-authorized-representative-zh-hans","tag-classification-zh-hans","tag-medical-devices-zh-hans","tag-mrg-zh-hans","tag-registration-zh-hans","tag-regulations-zh-hans","tag-sfda-zh-hans"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Importation Requirements of Medical Devices - MRGate<\/title>\n<meta name=\"description\" content=\"Importation requirements of medical devices intended for demonstration or training purposes only applicable to medical devices establishment\" \/>\n<meta name=\"robots\" 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