{"id":27155,"date":"2023-02-16T09:05:21","date_gmt":"2023-02-16T08:05:21","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27155"},"modified":"2023-02-10T10:00:03","modified_gmt":"2023-02-10T09:00:03","slug":"saudi-arabia-marketing-authorisation-required-for-low-risk-medical-devices-and-supplies","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/02\/16\/saudi-arabia-marketing-authorisation-required-for-low-risk-medical-devices-and-supplies\/","title":{"rendered":"SAUDI ARABIA: marketing authorisation required for low-risk medical devices and supplies"},"content":{"rendered":"

According to Circular No. MDS-CIR-001-V1\/220324<\/a> published by SFDA<\/a> (Saudi Food and Drug Authority<\/em>, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs), the deadline for submitting new or renewal applications for Class A (low-risk, non-measurement and non-sterile) Medical<\/strong> Devices<\/strong> under the MDNR<\/a> was 27 September 2022.<\/h2>\n

It is therefore mandatory<\/strong> that all such medical devices have a valid <\/strong>marketing authorisation<\/strong> in Saudi Arabia, otherwise they must be withdrawn from the market immediately<\/strong>.<\/p>\n

SFDA has also established the process of receiving applications for marketing authorisations for low-risk, non-sterile, non-measurement Medical Devices in the following ways:<\/p>\n

    \n
  1. Applications registered before<\/strong> 27\/09\/2022 will be valid until their expiry date<\/strong>;<\/li>\n
  2. New applications<\/strong> accepted until 27\/9\/2022 will be valid for one year<\/strong> from the date of acceptance. In addition, while the registration is valid, compliance with MDMA requirements must be ensured and an Authorised Representative must be appointed for foreign manufacturers.<\/li>\n
  3. As of 27\/09\/2022 for non-sterile, non-measuring low-risk Medical Devices, MDMA can be applied for through the Ghad System (Unified Electronic System)<\/a>.<\/li>\n<\/ol>\n

    >> Do you want to market your devices in the KSA market?<\/strong><\/h3>\n

    Thema\u2019s experts<\/strong> are at your disposal to give you the right guidance to market Medical Devices and IVDs in Saudi Arabia through effective and high-level strategic-regulatory consulting<\/a> services.<\/p>\n

    >> Need to appoint an Authorised Representative? <\/strong><\/h3>\n

    Choose Thema, our Local Representative<\/a> service can support you in the marketing and registration<\/a> of your Medical Devices and IVDs in Saudi Arabia.<\/p>\n

    Stay up to date on KSA marketing requirements and subscribe to our Newsletter<\/a>.<\/p>\n

    Contact us<\/a> for more information.<\/p>\n

    Sources: https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2022-12\/MD7122022A.pdf<\/a><\/p>\n

    https:\/\/www.sfda.gov.sa\/sites\/default\/files\/2022-03\/%28002%29.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

    According to Circular No. MDS-CIR-001-V1\/220324 published by SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices […]<\/p>\n","protected":false},"author":114,"featured_media":27171,"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-27155","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nSAUDI ARABIA: marketing authorisation required for low-risk medical devices and supplies<\/title>\n<meta name=\"description\" content=\"According to Circular No. MDS-CIR-001-V1\/220324 published by SFDA, the deadline for submitting new or renewal applications...\" \/>\n<meta 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