{"id":18483,"date":"2021-06-24T10:50:49","date_gmt":"2021-06-24T08:50:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18483"},"modified":"2023-01-25T17:22:40","modified_gmt":"2023-01-25T16:22:40","slug":"saudi-arabia-new-market-access-procedure-medical-devices-coming-soon","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/06\/24\/saudi-arabia-new-market-access-procedure-medical-devices-coming-soon\/","title":{"rendered":"SAUDI ARABIA: new market access procedure coming soon"},"content":{"rendered":"\r\n<p>The <strong>Kingdom of Saudi Arabia (KSA)<\/strong> has officially introduced the new Medical Devices Regulation, which is expected to come into effect by 2021.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-18431\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/06\/arabia-saudita-nuovo-regolamento-dispositivi-medici-1024x536.jpg\" alt=\"Saudi Arabia new market access procedure medical devices coming soon\" \/>\r\n<figcaption>New market access procedure coming soon<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>The Regulations were approved by the Saudi Government through Royal Decree No. (M\/54) and will replace the temporary Regulations currently in effect but retain most of their rules.<\/p>\r\n\r\n\r\n\r\n<p>The new Regulation will be the basis for reference that will allow the <strong>Saudi Food and Drug Authority (SFDA) <\/strong>to regulate the entry of Medical Devices into Saudi Arabia efficiently and safely.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Marketing Authorisation Applications through the GHTF<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>The <strong>SFDA<\/strong> may recognize and accept applications for Medical Devices (<strong>Medical Devices Marketing Authorization MDMA<\/strong>) from one of the founding countries of the former <strong>Global Harmonization Task Force (GHTF)<\/strong> \u2013 an international volunteer group of representatives for medical regulation authorities \u2013 such as <strong>the EU, USA, Canada, Japan and Australia<\/strong>. However, such applications through the GHTF will only be accepted only <strong>until 1 January 2022<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>After 1 January 2022, applications for registration must be submitted to the SFDA through the <strong>Technical File Assessment (TFA) <\/strong>procedure, which requires manufacturers to provide more documentation to demonstrate the conformity of the device.<\/p>\r\n\r\n\r\n\r\n<p>At the moment, according to the GHTF procedure, the submission of the <strong>Technical File Assessment (TFA) <\/strong>is still optional but the SFDA reserves the right to request it if deemed necessary.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>How to register a Medical Device in Saudi Arabia<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>To register the device with the SFDA identifying the applicable procedure, you must first identify the <strong>hazard class of the Medical Device<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>In this regard, the SFDA has published <strong>Version 5.0 <\/strong>of the \u201c<strong>Saudi FDA Products Classification Guidance<\/strong>\u201d which provides <strong>classification criteria and rules<\/strong>, based on what has already been defined by the MDR (EU) 2017\/745.<\/p>\r\n\r\n\r\n\r\n<p>Foreign manufacturers of <strong>high-risk medical devices <\/strong>must also appoint an <strong>Authorised Representative <\/strong>responsible for device registration and compliance with Saudi regulations, said registration must be done through a new <strong>system<\/strong>, the electronic platform <strong>GHAD<\/strong>.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Support for the registration of medical devices in Saudi Arabia<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Thanks to our <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/\">strategic-regulatory consulting services<\/a><\/strong> we can support you while registering your Medical Devices in Saudi Arabia. <a href=\"mailto:sales@thema-group.it\"><strong>Contact us<\/strong><\/a> for more information.<\/p>\r\n\r\n\r\n\r\n<p><em>Sources: <\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/laws.boe.gov.sa\/BoeLaws\/Laws\/LawDetails\/9daec1bf-6bda-4a65-a111-ace90163af7e\/1\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Royal Decree No. (M\/54), Kingdom of Saudi Arabia (KSA), 18 february 2021  (si apre in una nuova scheda)\">Royal Decree No. (M\/54), Kingdom of Saudi Arabia (KSA), 18 february 2021<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2021-03\/SFDAMDSystem.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Medical Devices Regulation, SFDA, 18 february 2021  (si apre in una nuova scheda)\">Medical Devices Regulation, SFDA, 18 february 2021<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/sfda.gov.sa\/sites\/default\/files\/2021-04\/ProductCGuideline-V5.0%D9%8FEN.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">&#8220;Saudi FDA Products Classification Guidance\u201d, SFDA, 22 may 2021<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>The Kingdom of Saudi Arabia (KSA) has officially introduced the new Medical Devices Regulation, which is expected to come into effect  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23063,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-18483","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>SA: new market access procedure medical devices coming soon<\/title>\n<meta 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