{"id":144991,"date":"2025-07-03T21:25:55","date_gmt":"2025-07-03T18:25:55","guid":{"rendered":"https:\/\/www.salamahlaw.com\/?p=144991"},"modified":"2025-07-03T21:32:03","modified_gmt":"2025-07-03T18:32:03","slug":"how-to-secure-a-license-to-establish-and-import-medical-devices-in-saudi-arabia","status":"publish","type":"post","link":"https:\/\/www.salamahlaw.com\/en\/how-to-secure-a-license-to-establish-and-import-medical-devices-in-saudi-arabia\/","title":{"rendered":"How to Secure a License to Establish and Import Medical Devices in Saudi Arabia"},"content":{"rendered":"

Licensing Requirements Under Saudi Medical Device Regulations<\/b><\/h2>\n

Article 15 of the Implementing Regulations on Medical Devices and Products\u2014issued by the Board of Directors of the Saudi Food and Drug Authority (SFDA) on 29\/12\/1429H\u2014requires importers and distributors of medical devices to obtain licensing for their facilities, branches, and warehouses from the SFDA. In this article, Salamah Law Firm outlines the legal requirements for investors seeking to obtain establishment and import licenses for medical devices <\/span>in Saudi Arabia.<\/span><\/p>\n

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What Is a Medical Device Establishment License in Saudi Arabia?<\/b><\/h2>\n

According to the Medical Devices and Supplies Law (1442H), a <\/span>medical device<\/b> is defined broadly as:<\/span><\/p>\n

“Any instrument, apparatus, appliance, implant, in vitro reagent, calibrator, software, or related item, whether used alone or in combination, intended by the manufacturer to be used for human diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, life support, or to assist in conception, sterilization, or medical information purposes derived from human samples. Devices do not achieve their primary intended action in\/on the human body through pharmacological, immunological, or metabolic means.”<\/span><\/p>\n

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Article 2 of the law specifies that the regulation applies to the <\/span>design, manufacture, import, marketing,<\/b> distribution, and storage<\/b> of such devices.<\/span><\/p>\n

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Legal Prohibition on Practicing Without a License<\/b><\/h2>\n

Article 6 clearly states:<\/span><\/p>\n

“No establishment may engage in any regulated activities without proper registration, licensing, and\u2014if a manufacturing facility\u2014an industrial license from the competent authority.”<\/span><\/p>\n

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Steps to Obtain a Medical Device Establishment License<\/b><\/h2>\n

To secure a new license for importing and distributing medical devices and products, investors must:<\/span><\/p>\n

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  1. Open an account<\/b> on the SFDA’s unified electronic platform (GHAD) to obtain a company account number.<\/span><\/li>\n
  2. Register on the GHAD platform<\/b> to apply for a license to conduct import and distribution activities.<\/span><\/li>\n
  3. Upon approval, <\/span>pay the licensing fees<\/b>. The license is granted only after implementing and documenting a <\/span>Quality Management System (QMS)<\/b> compliant with <\/span>ISO 13485:2016 (GSO\/SFDA equivalent)<\/b>.<\/span><\/li>\n
  4. Undergo an <\/span>on-site inspection<\/b> by SFDA officers.<\/span><\/li>\n<\/ol>\n

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    Conditions for Importing Medical Devices in Saudi Arabia<\/b><\/h2>\n

    To obtain an import license for medical devices, the applicant must provide:<\/span><\/p>\n