{"id":19641,"date":"2021-11-25T12:05:09","date_gmt":"2021-11-25T11:05:09","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=19641"},"modified":"2021-11-29T11:15:09","modified_gmt":"2021-11-29T10:15:09","slug":"saudi-arabia-udi-deadlines-for-medical-devices-postponed","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/11\/25\/saudi-arabia-udi-deadlines-for-medical-devices-postponed\/","title":{"rendered":"SAUDI ARABIA: UDI deadlines for Medical Devices postponed"},"content":{"rendered":"\n<p><strong>Saudi Food and Drug Authority (SFDA) <\/strong>\u2013 Regulatory Authority of Medical Devices market in Saudi Arabia \u2013 <strong>aims to<\/strong> increase patients\u2019 safety <strong>by optimizing devices traceability.<\/strong> As a consequence of this, SFDA decided to <strong>postpone UDI deadlines for Medical Devices<\/strong>, to give involved Operators more time to comply with Unique Medical Device Identifier System (UDI).<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/11\/arabia-saudita-proroga-scadenze-udi-dispositivi-medici-1024x536.jpg\" alt=\"Saudi Arabia UDI deadlines for Medical Devices postponed\" class=\"wp-image-19622\"\/><figcaption>UDI deadlines for Medical Devices postponed<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Which are the new UDI deadlines for Medical Devices?<\/strong><\/h2>\n\n\n\n<p><strong>UDI deadlines<\/strong> have been <strong>postponed as follow<\/strong>, according to\nmedical devices risk class:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Class D<\/strong> (high risk): from August 1, 2021, to <strong>September 1,\n2022<\/strong>.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Class B\nand C<\/strong> (medium risk): from February 1, 2022, to <strong>September\n1, 2022<\/strong>.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Class A<\/strong> (low risk): from February 1, 2023, to <strong>September 1,\n2023.<\/strong> <\/li><\/ul>\n\n\n\n<p>On September 2020, with regard to UDI requirements, SFDA published an\nupdate on the \u201c<strong>Guidance on Requirements for Unique Device Identification\n(UDI) for Medical Devices (MDS-G34)\u201d <\/strong>document to offer Manufacturers and\nother stakeholders, <strong>useful information<\/strong> on <strong>UDI system main\nrequirements<\/strong>. These need to be applied on devices authorised to be placed\non Saudi Arabia market. The document also offers crucial information on <strong>UDI\ndatabase (Saudi-DI)<\/strong> which is a fundamental element for unique devices\nidentification system because it contains updated info on products.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Main goals of UDI system implementation<\/strong><\/h2>\n\n\n\n<p>According to SFDA guideline, the main<strong> goals of the UDI system\nimplementation<\/strong> are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Providing accurate identification of Medical Devices and device-specific data.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Ensuring Medical Devices traceability.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Managing\ninformation in case of recalls, corrective measures, counterfeit devices, and\nadverse event reporting.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Establishing effective checks on Medical Devices during their life cycle. <\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Guaranteeing\nthat products are use in effective and safe ways.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you need more information on Medical Devices\nRegulation in Saudi Arabia?<\/strong><\/h2>\n\n\n\n<p>Thema experts are available for <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"consultancy (si apre in una nuova scheda)\">consultancy<\/a><\/strong> and to offer you information on regulatory scenario in Saudi Arabia. Additionally, if you want to <strong>register your devices<\/strong>, Thema experts will help during the whole registration process to market your products in full compliance with the Regulation.<\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-med.com\">Contact us<\/a><\/strong><a href=\"mailto:sales@thema-med.com\"> <\/a>for additional information!<\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2021-08\/SFDAUDI.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"UDI deadline extension for Medical Devices, SFDA, 2021 (si apre in una nuova scheda)\">UDI deadline extension for Medical Devices, SFDA, 2021<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2020-09\/MDS-G34e.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (MDS-G34), SFDA, 2020<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Saudi Food and Drug Authority (SFDA) \u2013 Regulatory Authority of Medical Devices market in Saudi Arabia \u2013 aims to increase patients\u2019  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":22222,"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":[1,2],"tags":[],"class_list":["post-19641","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","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>SAUDI ARABIA SFDA: UDI deadlines for medical devices postponed<\/title>\n<meta name=\"description\" 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