{"id":1332,"date":"2022-11-12T09:32:16","date_gmt":"2022-11-12T09:32:16","guid":{"rendered":"https:\/\/operonstrategist.com\/uk\/?page_id=1332"},"modified":"2025-03-27T08:47:55","modified_gmt":"2025-03-27T08:47:55","slug":"sfda-approval","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-gb\/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<\/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-16433c1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"16433c1\" 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-33 elementor-top-column elementor-element elementor-element-22b8555\" data-id=\"22b8555\" 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-3a8e130 elementor-widget elementor-widget-heading\" data-id=\"3a8e130\" 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\">Saudi Arabia Medical Device Regulations - Overview<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d9e39ef elementor-widget elementor-widget-text-editor\" data-id=\"3d9e39ef\" 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<div style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr; font-family: 'Segoe UI', 'Segoe UI Web', Arial, Verdana, sans-serif; font-size: 12px;\"><section class=\"elementor-section elementor-top-section elementor-element elementor-element-20a476fd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"20a476fd\" data-element_type=\"section\"><div class=\"elementor-container elementor-column-gap-default\"><div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-95818d9\" data-id=\"95818d9\" data-element_type=\"column\"><div class=\"elementor-widget-wrap elementor-element-populated\"><div class=\"elementor-element elementor-element-3d9e39ef elementor-widget elementor-widget-text-editor\" data-id=\"3d9e39ef\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div><p><span style=\"font-size: 12pt;\">SFDA has issued various guidelines for the regulations of medical devices. if you want to place product in Saudi Arabia you need approval from MDMA I.e Medical Device Market Authorization. <\/span><\/p><p><span lang=\"EN-US\" style=\"font-size: 12pt;\" xml:lang=\"EN-US\" data-contrast=\"none\">This is an electronic system and the aim of the system is to authorize medical devices once they comply with MDIR, which means <\/span><span lang=\"EN-US\" style=\"font-size: 12pt;\" xml:lang=\"EN-US\" data-contrast=\"none\">Medical Device Interim Regulations<\/span><span lang=\"EN-US\" style=\"font-size: 12pt;\" xml:lang=\"EN-US\" data-contrast=\"none\">.\u00a0<\/span><\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div>\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-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=\"510\" src=\"https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-1024x510.jpg\" class=\"attachment-large size-large wp-image-2455\" alt=\"\" srcset=\"https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-1024x510.jpg 1024w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-300x150.jpg 300w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-768x383.jpg 768w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-1536x766.jpg 1536w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-2048x1021.jpg 2048w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-500x249.jpg 500w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-800x399.jpg 800w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-1280x638.jpg 1280w, https:\/\/operonstrategist.com\/en-gb\/wp-content\/uploads\/2023\/10\/Medical-Device-RegistrationinSaudi-01-1920x957.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<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-7e21094\" data-id=\"7e21094\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-d26e030\" data-id=\"d26e030\" 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-ba8fa27 elementor-widget elementor-widget-heading\" data-id=\"ba8fa27\" 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-medium\">\nLooking for Consultation Services for Medical Device Registration in Saudi Arabia<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5aa544b elementor-widget elementor-widget-text-editor\" data-id=\"5aa544b\" 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>Let\u2019s have a talk about your project<\/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-5566802 elementor-widget elementor-widget-shortcode\" data-id=\"5566802\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><style id=\"wpforms-css-vars-2403\">\n\t\t\t\t#wpforms-2403 {\n\t\t\t\t\n\t\t\t}\n\t\t\t<\/style><div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-2403\"><form id=\"wpforms-form-2403\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"2403\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-gb\/wp-json\/wp\/v2\/pages\/1332\" data-token=\"8eb9b7c06ac02b24e2433cec69c95427\" data-token-time=\"1776021732\"><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-2403-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2403-field_0\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-2403-field_0\" class=\"wpforms-field-large wpforms-field-required\" 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value=\"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/pages\/1332\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2403\" 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-gb\/wp-content\/plugins\/wpforms-lite\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container --><\/div>\n\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-946bbe5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"946bbe5\" 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-c9b6b40\" data-id=\"c9b6b40\" 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-9cc4889 elementor-widget elementor-widget-heading\" data-id=\"9cc4889\" 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 Devices Registration Process 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-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><span class=\"TextRun SCXW217760464 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW217760464 BCX0\">We can summarize the medical device registration and approval process in the following few steps:<\/span><\/span><span class=\"EOP SCXW217760464 BCX0\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p><ol><li><b><span data-contrast=\"auto\">Appoint a Saudi authorized representative (AR)<\/span><\/b>\u00a0<br \/><span data-contrast=\"auto\">Through a knowledgeable AR, legal manufacturers can have advanced regulatory support with the ever-changing SFDA regulations. Even if there was an appointed AR before, manufacturers can transfer to a new AR and transfer all old MDMA approvals. Contact us for more details.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li><b><span data-contrast=\"auto\">Prepare the technical file for MDMA submission<\/span><\/b>\u00a0<br \/><span data-contrast=\"auto\">Companies must do a thorough gap analysis on the available file against the SFDA requirements in order to be ready for MDMA submission. Identifying the gaps is essential for determining the required research, reports, or post-approval commitments, such as PMCF in Saudi Arabia. Rejecting an application costs time and faces substantial SFDA expenses.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li><b><span data-contrast=\"auto\">MDMA Submission<\/span><\/b>\u00a0<br \/><span data-contrast=\"auto\">The SFDA will not accept a registration file that has clearly been submitted by a non-specialized regulatory professional. The SFDA\u2019s reply will not specify the gaps and what needs to be done; instead, the applicant will be asked to resubmit according to the applicable rules. If it was properly prepared, however, the applicant should expect technical inquiries similar to those received from notified bodies. The applicants will be given a limited number of waivers from responding to questions as well as a time frame.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li><b><span data-contrast=\"auto\">MDMA Approval<\/span><\/b>\u00a0<br \/><span data-contrast=\"auto\">Once granted by SFDA, the owner of the license, which is always the legal manufacturer, can ship the goods to Saudi with all necessary SFDA requirements for shipment clearance at Saudi ports.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ol>\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-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-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><b>SFDA Medical device registration and approval process:<\/b><\/p><p><b>\u00a0 \u00a0 \u00a0 \u00a0 Following are the Steps to register your medical devices:<\/b><\/p><p><b>\u00a0 \u00a0 \u00a0 \u00a01. Medical Device Classification:<\/b><\/p><p>\u00a0<\/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 second one is to assign a consulting office who can provide more power and freedom to the legal manufacturer in 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 device with SFDA and obtain a certificate from MDMA<\/span><b> (Medical Device Market Authorization) as per the MDIR (Medical Device Interim Regulations) 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<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<p><b>How we help you with regulatory service:<\/b><\/p><p><span style=\"font-weight: 400;\">If you are a new manufacturer or already active commercially, we Team of Operon Strategist ensure 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><div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6153a14a animated-slow animated fadeInUp\" data-id=\"6153a14a\" data-element_type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\u00a0<\/div>\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-0130792 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0130792\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-94ff265\" data-id=\"94ff265\" 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-486e25b elementor-widget elementor-widget-heading\" data-id=\"486e25b\" 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\">Operon Strategist Provides SFDA Registration Consultancy Services in Worldwide<\/h2>\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-0463d9b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0463d9b\" 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-7e9ae66\" data-id=\"7e9ae66\" 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-8f287be elementor-widget elementor-widget-text-editor\" data-id=\"8f287be\" 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><a href=\"https:\/\/operonstrategist.com\/en-sa\/services\/regulatory-approvals\/sfda-registration\/\"><strong>SFDA Registration for Medical Devices in the US<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-sa\/services\/regulatory-approvals\/sfda-registration\/\"><strong>SFDA Registration for Medical Devices in Saudi Arabia<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/regulatory-approvals\/sfda-medical-device-registration\/\"><strong>SFDA Registration for Medical Devices in Egypt<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/regulatory-approvals\/sfda-approval\/\"><strong>SFDA Registration for Medical Devices in the UK<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-de\/services\/regulatory-approvals\/sfda-approval\/\"><strong>SFDA Registration for Medical Devices in Germany<\/strong><\/a><\/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-e98e723\" data-id=\"e98e723\" 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-4451b64 elementor-widget elementor-widget-text-editor\" data-id=\"4451b64\" 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><a href=\"https:\/\/operonstrategist.com\/en-om\/services\/regulatory-approvals\/sfda-approval\/\"><strong>SFDA Registration for Medical Devices in Oman<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-za\/services\/regulatory-approvals\/sfda-approval\/\"><strong>SFDA Registration for Medical Devices in South Africa<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/medical-device-registration-in-saudi-arabia\/\"><strong>SFDA Registration for Medical Devices in India<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-ir\/sfda-approval\/\"><strong>SFDA Registration for Medical Devices in Iran<\/strong><\/a><\/p><p><a href=\"https:\/\/operonstrategist.com\/en-nl\/services\/regulatory-approvals\/sfda-approval\/\"><strong>SFDA Registration for Medical Devices in the Netherlands<\/strong><\/a><\/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\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 Saudi Arabia Medical Device Regulations &#8211; Overview SFDA has issued various guidelines for the regulations of medical devices. if you want to place product in Saudi Arabia you need approval from MDMA I.e Medical Device Market Authorization. This is an electronic system and the aim of the system is to authorize [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"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":""}},"footnotes":""},"class_list":["post-1332","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/pages\/1332","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/comments?post=1332"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/pages\/1332\/revisions"}],"predecessor-version":[{"id":2946,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/pages\/1332\/revisions\/2946"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/pages\/20"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/media?parent=1332"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}