{"id":8249,"date":"2020-12-29T13:56:05","date_gmt":"2020-12-29T10:56:05","guid":{"rendered":"https:\/\/mr-gate.com\/extending-deadline-for-receiving-requests-for-marketing-authorization-applications-via-ghtf-route\/"},"modified":"2023-10-01T23:06:49","modified_gmt":"2023-10-01T20:06:49","slug":"extending-deadline-for-receiving-requests-for-marketing-authorization-applications-via-ghtf-route","status":"publish","type":"post","link":"https:\/\/mr-gate.com\/zh-hans\/extending-deadline-for-receiving-requests-for-marketing-authorization-applications-via-ghtf-route\/","title":{"rendered":"Extending deadline for receiving requests for Marketing Authorization Applications via GHTF route."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8249\" class=\"elementor elementor-8249 elementor-5379\">\n\t\t\t\t\t\t\t        <section class=\"elementor-section elementor-top-section elementor-element elementor-element-66080b1f elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"66080b1f\" data-element_type=\"section\">\n            \n                        <div class=\"elementor-container elementor-column-gap-wider \">\n                    <div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-58c2b8b7\" data-id=\"58c2b8b7\" data-element_type=\"column\">\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\n                        \t\t<div class=\"elementor-element elementor-element-18eb1cd elementor-widget elementor-widget-text-editor\" data-id=\"18eb1cd\" 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<p><\/p>\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<p><\/p>\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_f38315-6e\">\n<div class=\"kt-inside-inner-col\">\n<p><\/p>\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<p><\/p>\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_97fb67-c7\">\n<div class=\"kt-inside-inner-col\">\n<p><\/p>\n<h4 id=\"kt-adv-heading_af9b0c-4f\" class=\"kt-adv-heading_af9b0c-4f wp-block-kadence-advancedheading\" style=\"text-align: center;\">SFDA has recently announced extending the deadline for receiving requests for Medical Device Marketing Authorization applications; Click <a href=\"https:\/\/sfda.gov.sa\/sites\/default\/files\/2020-12\/SFDA-MDaa1.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a> to read the official document.<\/h4>\n<p><\/p>\n<p class=\"has-text-align-center\">Published on: 28th December, 2020<\/p>\n<p><\/p>\n<\/div>\n<\/div>\n<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\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<p><\/p>\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<p><\/p>\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<p><\/p>\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<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\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<p><\/p>\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<p><\/p>\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<p><\/p>\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<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\n<\/div>\n<\/div>\n<p><\/p>\n<\/div>\n<div class=\"kt-row-layout-bottom-sep kt-row-sep-type-sltl\"> <\/div>\n<\/div>\n<\/div>\n<p><\/p>\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<p><\/p>\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_c46290-ad\">\n<div class=\"kt-inside-inner-col\">\n<p><\/p>\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<p><\/p>\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<p><\/p>\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<p><\/p>\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_b4bb58-96\">\n<div class=\"kt-inside-inner-col\">\n<p><\/p>\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<p><\/p>\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><\/p>\n<p>This announcement is intended for <a href=\"https:\/\/mr-gate.com\/zh-hans\/service\/services-in-ksa\/\">Medical Devices<\/a> Marketing Authorizations Applications <\/p>\n<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\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><\/p>\n<p>This announcement applies to local and Overseas Medical Devices Manufacturers and Authorized Representatives.<\/p>\n<p><\/p>\n<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane_224e4f-02\">\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\">General Notes<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p><\/p>\n<p>In reference to the requirements for Medical Devices listing and Marketing Authorization published on 22nd June 2020, Stating that the last day for accepting applications via the GHTF route is 01st January 2021. <a href=\"https:\/\/www.sfda.gov.sa\/en\" target=\"_blank\" rel=\"noopener\">SFDA<\/a> would like to inform you the following:<\/p>\n<p><\/p>\n<ul>\n<li><em>Receiving new marketing authorization requests via the GHTF route will be extended until (01\/07\/2021), and optionally via the Saudi Route (TFA), SFDA reserve the right to request the technical file or part of it whenever needed. <\/em><\/li>\n<li><em>Receiving renewal and updating marketing authorization requests via the GHTF route will be until 01\/01\/2022<\/em><\/li>\n<\/ul>\n<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><\/p>\n<\/div>\n<\/div>\n<p><\/p>\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_fa00c6-87\">\n<div class=\"kt-inside-inner-col\">\n<p><\/p>\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<p><\/p>\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane_01f627-99\"> <\/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<p><\/p>\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<p><\/p>\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_20a4ed-c6\">\n<div class=\"kt-inside-inner-col\">\n<p><\/p>\n<div class=\"wp-block-group\">\n<div class=\"wp-block-group__inner-container\">\n<p><\/p>\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<p><\/p>\n<\/div>\n<\/div>\n<p><\/p>\n<div class=\"wp-block-group\">\n<div class=\"wp-block-group__inner-container\">\n<p><\/p>\n<p class=\"has-text-align-center\"> <\/p>\n<p><\/p>\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 announced extending the deadline for  [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":7525,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[170],"tags":[184,173,174,175,176,171,172],"class_list":["post-8249","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-announcements-zh-hans","tag-applications-zh-hans","tag-authorized-representative-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>Marketing Authorization Applications - requests via GHTF<\/title>\n<meta name=\"description\" content=\"Medical 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