Regulations
The medical device market in the Middle East is governed by different regulatory systems that consider the health of the patient and quality of products. Although each nation such as Saudi Arabia, Kuwait, Qatar, and Turkey has its unique portal and regulating authority, they all share one common factor: a risk-based classification system.
Whether it is the “Saudi Route” approach by the SFDA or the European-style ÜTS framework adopted in Turkey, manufacturers need to have their technical documents and ISO 13485 certified internationally, and provide multiple labeling in order to obtain approval in the market. The following manual explains how that can be achieved. This guide provides an overview of the necessary routes, timeframes, and expenses involved in registering their products effectively in these major regional markets.
Morulaa Health Tech offers specialized knowledge and support for technical documentation, and timeline management customized to the specific legal requirements of your target markets. Our expertise verifies compliant pathways for your middle east medical device registrations.
SAUDI ARABIA MEDICAL DEVICE REGISTRATION
The Saudi Arabia medical device registration process follows a risk-based regulatory and requirements approach under the “Saudi Route” (MDMA2). This system focuses on independent technical evaluation rather than depending on foreign approvals. Foreign manufacturers must appoint a Saudi-based authorized representative to manage submissions through the GHAD portal and handle post-market compliance activities. Medical devices are classified from Class A low risk to Class D high risk.
The submission dossier must include technical specifications, an essential principles (EP) Checklist, Unique Device Identification (UDI) details, labeling and instructions for use (IFU) in both Arabic and English. The SFDA registration costs, which generally begin at around SAR 15,000 for Class A devices and can exceed SAR 40,000 for Class D devices.
The registration timeline includes an initial review of approximately 15 days, while the full technical review may take between 35 and 120 working days depending on the device classification. Additionally, priority assessment pathways are available for innovative medical technologies. Successfully reviewed the sFDA issues with the MDMA certificate. In 2026 SFDA regulations (MDS - REQ 10) now have a more required quality management system. Even with a valid ISO 13485, the SFDA now requires raw audit reports for all applications are class C and class D manufacturers, the SFDA has increased the frequency of its own on site or remote inspections, making a successful audit a potential precondition for MDMA approval.
KUWAIT MEDICAL DEVICE REGISTRATION
To register a device in Kuwait, manufacturers have to follow the regulatory requirements formed by the Ministry of Health and the MMPRRA. As per Ministerial Decree No. 387 Of 2025 manufacturers from outside Kuwait must have a representative in Kuwait.The LAR serves as the contact between the manufacturer and the Kuwaiti authorities, handling all submissions and ensuring compliance with the rules during the Kuwait medical device registration journey.
Medical devices are grouped into four classes: A, B, C and D. This includes a file for evaluation that is based on STE. Compliance with the ISO 13485 standard for medical device and quality management systems is mandatory. Labels on the device should be in both Arabic and English languages.
Kuwait's current regulatory system is the review pathway where devices that already hold approvals such as FDA clearance or CE marking can benefit from a fastrack review process, typically reducing approval timelines to around 3 to 6 months. While the standard registration may take approximately 6 to 9 months.
The official MOH registration fee is around 25 or 26 kuwaiti dinars (approximately USD 85) per application. To enhance efficiency and cost-effectiveness, the framework permits manufacturers to group as many as 50 associated products into one application.
QATAR MEDICAL DEVICE REGISTRATION
Qatar medical device registration requirements are managed by the Ministry of Public Health, through the Pharmacy and Drug Control Department. Qatar has a risk based classification system. High risk and implantable devices usually require a registration process with detailed technical evaluation, while low risk consumables and general devices may qualify for a simple import permit procedure. Obtaining clearance from international bodies, such as the US FDA, or verifying the device holds a CE mark from a European notified body is mandatory.
Manufacturers should provide the combined documentation for an approved Certificate of Free Sale (CFS), ISO 13485 certification, and technical documentation to prove the safety, efficacy, and performance of the medical device. Additionally, in Qatar all labels and IFUs should be provided in both English and Arabic languages.
In Qatar, processing timelines depend heavily on the device's risk category. Lower-risk devices can get import permits quickly, usually within 1 to 2 weeks. Higher-risk devices require a thorough technical examination, which typically takes 6 to 8 months for standard approval (or 3 to 5 months if eligible for a fast-track pathway).
TURKEY MEDICAL DEVICE REGISTRATION
Turkey medical device registration requirements are managed by the Turkish medicines and medical devices agency. The process is the product tracking system (ÜTS), a mandatory digital platform where every product must be recorded for market clearance. Since 2026 Turkey has integrated with EU MDR (2017/745) and IVDR (2017/746). Foreign companies cannot apply directly and must appoint a Turkish authorized representative to manage the ÜTS account and handle legal obligations within the country.
The submission dossier must have documents. These include a declaration of conformity, ISO 13485 certificate, updated technical documentation, product labels and Instructions for Use (IFU).
They must be translated into Turkish to comply with rules. After all documents are submitted through the ÜTS portal, the approval process generally takes between 60 and 120 days, depending on the device classification and the completeness and accuracy of the submitted documentation. Regarding fees, TİTCK publishes an annual price list in Turkish Lira. While simple product notifications may carry low costs, manufacturers must pay specific Certificate Registration Fees and annual system maintenance dues.
How Morulaa Can Help With Middle East Medical Device Registration
Middle East medical Device Registration shouldn't feel like an uphill battle against paperwork. At Morulaa, we act as your local regulatory department, handling the registration process. From navigating the GHAD portal in Saudi Arabia to coordinating with Turkey’s ÜTS system, we handle your registration from beginning to end. We help find your Local Authorized Representative, organize your ISO 13485 documents and check that every label is correctly translated into Arabic or Turkish. Our main aim is to cut the difficulties and get your products to market quickly. We want to make sure your products get to healthcare providers and patients who need them.
Is an authorized local representative required for the Middle East Medical device registration ?
Yes. It is not possible for foreign producers to register directly. You must engage an authorized local representative in each individual nation, such as through the GHAD portal in Saudi Arabia or ÜTS in Turkey.
Does a CE Mark or FDA approval guarantee registration?
No, but it fast-tracks it. While countries like Kuwait and Qatar use "abridged" pathways to reduce timelines to 3 to 6 months for approved devices, Saudi Arabia now requires a full technical review (MDMA2) regardless of foreign status.
What are the language requirements for labeling?
Bilingual labeling is essential. Arabic and English are mandatory for patient-facing materials (IFUs and labels) in Saudi Arabia, Egypt, Kuwait, and Qatar. Turkey requires all materials to be translated into Turkish.
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