{"id":8272,"date":"2020-11-22T18:15:29","date_gmt":"2020-11-22T15:15:29","guid":{"rendered":"https:\/\/mr-gate.com\/sfdas-guidance-on-requirements-for-medical-masks-and-particulate-respirators\/"},"modified":"2023-10-01T23:10:27","modified_gmt":"2023-10-01T20:10:27","slug":"sfdas-guidance-on-requirements-for-medical-masks-and-particulate-respirators","status":"publish","type":"post","link":"https:\/\/mr-gate.com\/zh-hans\/sfdas-guidance-on-requirements-for-medical-masks-and-particulate-respirators\/","title":{"rendered":"SFDA&#8217;s Guidance on Requirements for Medical Masks and Particulate Respirators"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8272\" class=\"elementor elementor-8272 elementor-5228\">\n\t\t\t\t\t\t\t        <section class=\"elementor-section elementor-top-section elementor-element elementor-element-60a7169f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"60a7169f\" 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-f4716fe\" data-id=\"f4716fe\" data-element_type=\"column\">\n            <div class=\"elementor-widget-wrap elementor-element-populated\">\n                        \t\t<div class=\"elementor-element elementor-element-2b3d8dc2 elementor-widget elementor-widget-text-editor\" data-id=\"2b3d8dc2\" 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 on Medical Masks and Particulate Respirators -Recognized Standards; Click <a href=\"https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2020-10\/MDS-G46e.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a> to read the official document.<\/h4>\n\n<p class=\"has-text-align-center\">Published on: 26th October, 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 document clarifies the requirements for obtaining Medical Devices Marketing Authorization of Medical Masks, in order to place them on the market within KSA.<\/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 guidance applies to: Manufacturers, Authorized Representatives, Importers and distributors.<\/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\">What is not included?<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Non Medical Masks that are labeled as &#8220;For Non-Medical Use&#8221; which are regulated by the Saudi Standards, <a href=\"https:\/\/saso.gov.sa\/en\/pages\/default.aspx\" target=\"_blank\" rel=\"noopener\">Metrology and Quality Organization (SASO)<\/a>.<\/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\">General<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Medical masks and particulate respirators shall obtain <a href=\"https:\/\/mr-gate.com\/zh-hans\/service\/services-in-ksa\/\">Medical Devices <\/a>Marketing Authorization (MDMA), and shall comply with the requirements specified in \u201cGuidance on Requirements for Listing and Medical Device Marketing Authorization (MDS \u2013 G5)\u201d, including \u201cEssential Principles of Safety and Performance\u201d specified in the mentioned guidance.<\/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>Classification and Applications of Medical Face Masks<\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Medical Face masks can be divided into three levels:<\/p>\n\n<ul>\n<li>Level (A): BFE \u2265 95%<br>To be used for general medical procedures where there is no risk of blood or body fluid splash.<\/li>\n<\/ul>\n\n<ul>\n<li>Level (B): BFE \u2265 98% without or with low splash resistance.<br>To be used in Emergency, change dressing room, dentistry, and other similar procedures<\/li>\n<\/ul>\n\n<ul>\n<li>Level (C): BFE \u2265 98% with high splash resistance.<br>To be used in surgical procedures or other procedures with similar requirements<\/li>\n<\/ul>\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>Examples of Requires Tests<\/strong> for Medical Masks<\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<p>Required tests for medical mask:<\/p>\n\n<ul>\n<li>Bacterial filtration efficiency (BFE)<\/li>\n<li>Breathability (Differential pressure)<\/li>\n<li>Splash resistance\/Penetration by Synthetic Blood<\/li>\n<li>Microbial cleanliness (Bioburden)<\/li>\n<li>Biocompatibility<\/li>\n<li>Sub-Micron Particulate Filtration<\/li>\n<li>Flammability test<\/li>\n<\/ul>\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><strong>Examples of Requires Tests for Particulate Respirators<\/strong><\/strong><\/span><\/span><\/button><\/div>\n<div class=\"kt-accordion-panel\">\n<div class=\"kt-accordion-panel-inner\">\n<ul>\n<li>Differential pressure following appropriate NIOSH standard test procedures (STPs)<\/li>\n<li>Particulate filtration efficiency following appropriate NIOSH standard test procedure<\/li>\n<li>Exhalation valve leakage following appropriate NIOSH standard test procedure (STP)<\/li>\n<\/ul>\n\n<p>Biocompatibility<\/p>\n\n<ul>\n<li>Splash resistance\/Penetration by Synthetic Blood<\/li>\n<li>Practical performance<\/li>\n<li>Leakage<\/li>\n<li>Flammability<\/li>\n<li>Carbon dioxide content of the inhalation air<\/li>\n<li>Strength of attachment of exhalation valve housing<\/li>\n<li>Breathing Resistance<\/li>\n<li>Clogging<\/li>\n<\/ul>\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 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       <\/section>\n        \t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>SFDA has recently published a Guidance on Medical Masks [&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-8272","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>Medical Masks and Particulate Respirators requirement<\/title>\n<meta name=\"description\" content=\"Medical Masks and 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