{"id":1332,"date":"2022-11-12T09:32:16","date_gmt":"2022-11-12T09:32:16","guid":{"rendered":"https:\/\/operonstrategist.com\/southafrica\/?page_id=1332"},"modified":"2025-03-28T05:26:46","modified_gmt":"2025-03-28T05:26:46","slug":"sfda-approval","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-za\/services\/regulatory-approvals\/sfda-approval\/","title":{"rendered":"SFDA APPROVAL"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1332\" class=\"elementor elementor-1332\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2216d1d2 banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2216d1d2\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3b28bbcd\" data-id=\"3b28bbcd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-935d77a banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"935d77a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">SFDA Medical Device Registration in South Africa<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4d69630e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4d69630e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7b3ce91f\" data-id=\"7b3ce91f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6bdf83cb elementor-widget elementor-widget-text-editor\" data-id=\"6bdf83cb\" 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<h2><b>SFDA Medical Device Registration and Regulations<\/b><\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1279a6c8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1279a6c8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-438c4d96\" data-id=\"438c4d96\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-694cc566 elementor-widget elementor-widget-text-editor\" data-id=\"694cc566\" 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 style=\"text-align: left;\">KSA (Kingdom of Saudi Arabia) has been rated among the top 20 economically competitive countries in the world. SFDA is a regulatory authority for medical devices and IVDs sold and distributed in Saudi Arabia. MDMA approval is needed to place your devices in the Saudi Arabian market. SFDA reviews MDMA applications and prepares your submission carefully. Saudi Arabia updated their medical device regulations between 2019 and 2022, which affected device classification and changed the concept and content of the MDMA (high-risk application). Due to the changes and updated guidance, previously approved devices, IVDs, and medical supplies must comply with new regulations. As a medical device regulatory consultant, we always keep an eye on changes in regulations and current updates so that we can serve our clients better.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-1e3d4024\" data-id=\"1e3d4024\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-76a8772c elementor-widget elementor-widget-image\" data-id=\"76a8772c\" 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=\"1024\" height=\"536\" src=\"https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-1024x536.jpg\" class=\"attachment-large size-large wp-image-1348\" alt=\"SFDA Medical Device Registration\" srcset=\"https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-768x402.jpg 768w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-1536x804.jpg 1536w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-2048x1072.jpg 2048w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-500x262.jpg 500w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-800x419.jpg 800w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-1280x670.jpg 1280w, https:\/\/operonstrategist.com\/en-za\/wp-content\/uploads\/2022\/11\/SFDA-Web-Image-1-4-1920x1005.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-64b0dfb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"64b0dfb\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-3ef679a\" data-id=\"3ef679a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d9c93c4 elementor-widget elementor-widget-heading\" data-id=\"d9c93c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medical Device Registration And Approvals in Saudi Arabia<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-afb4331 elementor-widget elementor-widget-text-editor\" data-id=\"afb4331\" 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><strong>Medical Device Marketing Authorization (MDMA)<\/strong><\/p><p>In Saudi Arabia, all medical devices (except certain classifications) require <strong>Medical Device Marketing Authorization (MDMA)<\/strong> for market entry. The <strong>Saudi Food and Drug Authority (SFDA)<\/strong> typically processes MDMA approvals within <strong>35 days<\/strong>. Approved licenses remain valid for either the <strong>original license duration<\/strong> or <strong>three years<\/strong> if no specific duration is defined.<\/p>\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-dba5ca6 elementor-widget elementor-widget-heading\" data-id=\"dba5ca6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">SFDA Registration Documents List:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21f4250 elementor-widget elementor-widget-text-editor\" data-id=\"21f4250\" 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<ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Application Form<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Authorized Representative<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Technical File<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Conformity Assessment Report<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Medical Device Market Authorization Certificate<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1d77b5a\" data-id=\"1d77b5a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4c4f9c4 elementor-widget elementor-widget-heading\" data-id=\"4c4f9c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Looking For Medical Device Regulatory Consultants?<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2e86fb elementor-widget elementor-widget-wpforms\" data-id=\"a2e86fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-2867\"><form id=\"wpforms-form-2867\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"2867\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-za\/wp-json\/wp\/v2\/pages\/1332\" data-token=\"59ab3d447f11d98b5ec67947155c4202\" data-token-time=\"1775825587\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-2867-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_0\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-2867-field_0\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][0]\" placeholder=\"Name\" aria-errormessage=\"wpforms-2867-field_0-error\" required><\/div><div id=\"wpforms-2867-field_3-container\" class=\"wpforms-field wpforms-field-number\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"number\" id=\"wpforms-2867-field_3\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][3]\" placeholder=\"Phone\" step=\"any\" aria-errormessage=\"wpforms-2867-field_3-error\" required><\/div><div id=\"wpforms-2867-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_1\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-2867-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Email\" spellcheck=\"false\" aria-errormessage=\"wpforms-2867-field_1-error\" required><\/div><div id=\"wpforms-2867-field_2-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_2\" aria-hidden=\"false\">Comment or Message <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-2867-field_2\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Message\" aria-errormessage=\"wpforms-2867-field_2-error\" required><\/textarea><\/div><div id=\"wpforms-2867-field_4-container\" class=\"wpforms-field wpforms-field-select wpforms-field-select-style-classic\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2867-field_4\" aria-hidden=\"false\">From where do you hear about us?<\/label><select id=\"wpforms-2867-field_4\" class=\"wpforms-field-large\" name=\"wpforms[fields][4]\"><option value=\"Google\/Web Search\"  class=\"choice-1 depth-1\"  >Google\/Web Search<\/option><option value=\"Social Media\"  class=\"choice-2 depth-1\"  >Social Media<\/option><option value=\"Email Marketing\"  class=\"choice-3 depth-1\"  >Email Marketing<\/option><option value=\"Shows\/Exhibitions\"  class=\"choice-4 depth-1\"  >Shows\/Exhibitions<\/option><option value=\"Print Advertisements\"  class=\"choice-5 depth-1\"  >Print Advertisements<\/option><option value=\"Other\"  class=\"choice-6 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"2867\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/1332\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2867\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/en-za\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7c0b34ec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7c0b34ec\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1516889b\" data-id=\"1516889b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e462925 elementor-widget elementor-widget-heading\" data-id=\"e462925\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">SFDA Medical Device Registration and Approval Process<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52cabd4c elementor-widget elementor-widget-text-editor\" data-id=\"52cabd4c\" 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><strong>Following Are the Steps to Register Your Medical Devices:<\/strong><\/p><p><b>\u00a0 \u00a0 \u00a0 \u00a01. Medical Device Classification:<\/b><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-314ceedb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"314ceedb\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-45e69e86\" data-id=\"45e69e86\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3aa75aa7 elementor-widget elementor-widget-text-editor\" data-id=\"3aa75aa7\" 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<table><tbody><tr><td><p><b>SFDA device classification\u00a0<\/b><\/p><\/td><td><p><b>Risk class<\/b><\/p><\/td><td><p><b>MDR rule\u00a0<\/b><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">A<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">low<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">I<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">A-sterile\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low-medium\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Is<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">A-Measuring functions\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low \u2013medium\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Im<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">A-Reusable surgical instrument\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low-Medium\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Ir<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">B<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low-Medium<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">IIa\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">C<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Medium -High<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">IIb<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">D<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">High\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">III<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4184d137\" data-id=\"4184d137\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2ceb452f elementor-widget elementor-widget-text-editor\" data-id=\"2ceb452f\" 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;\">The SFDA is also adopting the European medical device regulation IVDR:<\/span><\/p><p>\u00a0<\/p><table><tbody><tr><td><p><span style=\"font-weight: 400;\">SFDA medical devices class<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Risk class<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Classification rule\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">A<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">A<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">B<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Moderate\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">B<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">C<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Moderate-High<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">D<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">High<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">D<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d1639e1 elementor-widget elementor-widget-text-editor\" data-id=\"6d1639e1\" 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<ol start=\"2\"><li><b>Appointment of AR If Needed<\/b><\/li><\/ol><p><span style=\"font-weight: 400;\">Authorized representatives (AR) need to be registered and approved by SFDA. The legal manufacturers have two options one is to assign their local distributor and the second one is to assign a consulting office that can provide more power and freedom to the legal manufacturer in the market. Low-risk medical devices don\u2019t need AR.<\/span><\/p><ol start=\"3\"><li><b>Apply to MDMA and Medical device registration:<\/b><\/li><\/ol><p><span style=\"font-weight: 400;\">Medical device manufacturers need to register their devices with SFDA and obtain a certificate from MDMA<\/span><b> (Medical Device Market Authorization) as per the MDIR (Medical Device Interim Regulations) in Saudi Arabia. MDMA is needed for high-risk devices whereas low-risk devices (non-sterile, non-measuring) don&#8217;t require prolonged MDMA.<\/b><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2d24729 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2d24729\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-89c0bfa\" data-id=\"89c0bfa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5d6c7035 elementor-widget elementor-widget-text-editor\" data-id=\"5d6c7035\" 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<h2>How We Help You With Regulatory Service<\/h2><p><span style=\"font-weight: 400;\">If you are a new manufacturer or already active commercially, our Team of Operon Strategists ensures compliance and efficient regulatory support through\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u00a0Providing Assistance in regulatory processes<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u00a0Providing Guidance for QMS establishments<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">We help our clients in design and development &amp; GAP analysis for products and companies.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">We create technical files for submission.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Provide proper response and submission to SFDA inquiries<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Follow up till regulatory approval.\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Feel free to ask any related query or avail <span style=\"box-sizing: border-box;\">yourself of our services\u00a0<a href=\"https:\/\/operonstrategist.com\/southafrica\/contact-us\/\" target=\"_blank\" rel=\"noopener\">by contacting us.<\/a><\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>SFDA Medical Device Registration in South Africa SFDA Medical Device Registration and Regulations KSA (Kingdom of Saudi Arabia) has been rated among the top 20 economically competitive countries in the world. SFDA is a regulatory authority for medical devices and IVDs sold and distributed in Saudi Arabia. MDMA approval is needed to place your devices [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":1348,"parent":20,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_vp_format_video_url":"","_vp_image_focal_point":[],"footnotes":""},"class_list":["post-1332","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/1332","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/comments?post=1332"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/1332\/revisions"}],"predecessor-version":[{"id":3500,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/1332\/revisions\/3500"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/pages\/20"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/media\/1348"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-za\/wp-json\/wp\/v2\/media?parent=1332"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}