{"id":8280,"date":"2020-11-22T14:50:44","date_gmt":"2020-11-22T11:50:44","guid":{"rendered":"https:\/\/mr-gate.com\/sfdas-products-classification-guidance\/"},"modified":"2023-10-01T23:11:56","modified_gmt":"2023-10-01T20:11:56","slug":"sfdas-products-classification-guidance","status":"publish","type":"post","link":"https:\/\/mr-gate.com\/zh-hans\/sfdas-products-classification-guidance\/","title":{"rendered":"SFDA&#8217;s Products Classification Guidance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8280\" class=\"elementor elementor-8280 elementor-5209\">\n\t\t\t\t\t\t\t        <section class=\"elementor-section elementor-top-section elementor-element elementor-element-759deef7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"759deef7\" 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-6f254358\" data-id=\"6f254358\" data-element_type=\"column\">\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\n                        \t\t<div class=\"elementor-element elementor-element-5876f5bb elementor-widget elementor-widget-text-editor\" data-id=\"5876f5bb\" 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;\">SFDA has recently published a Guidance for Product Classification Criteria; Click <a href=\"https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2020-10\/SFDAProductsClassificationGuidance-e.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a> to read the official document.<\/h4>\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\">Scope<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>This guidance document pertains to a product or category of products that is under the responsibility of each sector within <a href=\"https:\/\/www.sfda.gov.sa\/en\" target=\"_blank\" rel=\"noopener\">SFDA<\/a> regulation.<\/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\">Objective<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>This guidance presents the Saudi Food and Drug Authority\u2019s (SFDA\u2019s) current view on specific products or a category of products and whether it should be under the responsibility of Saudi Food and Drug Authority and particularly where the regulation may be on the borderline between two or more SFDA sectors. However, this guidance is not all-inclusive. Moreover, it does not provide any information about risk classes of medical devices.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\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\">e-Product Classification System (PCS) Use Process<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>In this guidance, SFDA states the services provided on this online system and the general process of obtaining a classification result from SFDA on your products<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\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-10-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\">Major Changes\/Updates: 4.1 Human Pharmaceutical Drug<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Ear Saline Preparations are considered now as <a href=\"https:\/\/mr-gate.com\/zh-hans\/service\/services-in-ksa\/\">Medical Devices<\/a> (Point 6.18)<\/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>Major Changes\/Updates: 4.4.2 Health Products<\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Nasal saline are considered as medical devices (Point 6.18)<\/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>Major Changes\/Updates: 6.16 Devices registered as<\/strong> <strong>Medical Devices without<\/strong> <strong>an intended medical purpose:<\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Dermal fillers containing Hyaluronic acid are considered<br>as medical devices<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-9 kt-pane_252123-c9\">\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>Major Changes\/Updates: <\/strong>6.17 Ophthalmic Products<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Eye drops intended for the alleviation dryness or discomfort caused by environmental factors are considered medical devices (See Point 6.17.2)<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-10 kt-pane_da8fdf-34\">\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>Major Changes\/Updates: 6.18 Nasal and Ear Saline Preparations<\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Nasal and ear saline preparations are considered medical<br>devices<\/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 for Product Clas [&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-8280","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":"<!-- 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