Regulations
Last Updated: 08 August 2026
Navigating Middle East Medical Device Registration across various markets requires understanding systems concerning patient safety and product quality. Despite each country, such as Saudi Arabia, Kuwait, Qatar, and Turkey, having their own portal and regulatory authority, the countries have one thing in common: a risk based classification system.
Whether it is the “Saudi Route” of the SFDA or the European style ÜTS in Turkey, companies need to prepare their technical files and have ISO 13485 international certification and multiple labeling to get their products approved in the Middle Eastern market. Below you will find a brief description of the ways to register your devices in these countries, including approximate time and cost frames. Morulaa Health Tech can assist you with technical documentation, and timeline preparation according to the required regulations in your chosen country/countries. Our experts ensure the correct route for your Middle East Medical Device Registration.
Middle East Medical Device Registration: Saudi Arabia medical device registration Guidelines
The Saudi Arabia medical device registration procedure is conducted by applying the risk based regulation and requirements according to "Saudi Route" (MDMA2). The approach relies on the independent technical assessment of a medical product rather than the certification in other jurisdictions. The representatives of foreign manufacturing companies are obliged to have the authorized representative established in Saudi Arabia to submit the application via the GHAD portal for saudi arabia medical device registration as well as to coordinate the post market compliance procedures. The medical devices are classified into Class A (low risk), Class B, Class C, and Class D (high risk) groups. The dossier should contain the technical documentation, essential principles (EP) checklist, Unique Device Identification (UDI) data, labeling and IFU in Arabic and English language. The SFDA registration fees vary starting from SAR 15,000 for Class A products up to SAR 40,000 for Class D devices. The registration process includes the first review lasting approximately 15 days, technical assessment (between 35 and 120 working days) depending on the classification of the medical device. Besides, there is a possibility of obtaining a priority assessment pathway for innovative medical technologies. Successfully reviewed by the FDA, increases the chances of the Saudi Arabia medical device registration certificate being issued. Now, SFDA has a MDS REQ 10 regulation for 2026 that imposes the more strict quality management system requirement. Having a valid ISO 13485 certificate is a supplementary option as SFDA can demand this while the SFDA demands raw audit reports from all class C and class D manufacturers. Furthermore, the SFDA increases the number of their own on site/remote audits which makes a successful audit a possible pre condition for MDMA approval.
Kuwait medical device registration
To complete a Kuwait medical device registration, the manufacturers are required to adhere to the regulations developed by the Ministry of Health and the MMPRRA. According to Ministerial Decree No. 387 Of 2025, manufacturers from countries other than Kuwait will need to have representatives in Kuwait. The LAR acts as a liaison between the manufacturer and the Kuwait authorities during the submission process and ensures that the regulations are followed through the entire Kuwait medical device registration process. Medical devices are classified in four classes: A, B, C, and D. This requires that there will be a file for evaluation which is based on STE. Compliance with the ISO 13485 standard of medical device and quality management systems is a requirement. It is important that labels in the device be in the two languages: Arabic and English. The current regulatory process in Kuwait is the review pathway. Devices that already have approvals, such as FDA clearance and CE Marking, will go through the fast track process and will only take three to six months to gain approval. Standard Kuwait medical device registration may take six to nine months. The official MOH registration fee is estimated at 25 or 26 Kuwaiti dinars (equivalent to USD 85). To improve efficiency and cost effectiveness, the process allows grouping up to fifty associated products in one application.
Qatar Medical Device Registration
Qatar medical device registration requirements are regulated by the Ministry of Public Health via the Pharmacy and Drug Control Department. Qatar follows a risk based classification scheme. In case of high risk and implantable devices, a qatar medical device registration procedure with a comprehensive technical evaluation is necessary, while low risk consumables and general devices might be suitable for the import permit procedure. Getting approvals from the international regulatory bodies like the US FDA, or having the CE mark issued by the European notified body is mandatory.
Manufacturers have to submit the combined documentation for obtaining an approved Certificate of Free Sale (CFS), ISO 13485 certification, and technical documentation proving the safety, efficacy, and performance of the medical device. Moreover, all labeling and IFUs in Qatar should be available in both English and Arabic languages.
The timeframes for Qatar medical device registration are largely dependent on the risk category of the product. Low risk devices could obtain an import permit rather quickly within 1 2 weeks. High risk devices will need to pass a comprehensive technical evaluation process which usually takes 6-8 months for standard approval (3-5 months for fast track procedure).
Turkey Medical Device Registration
Registration requirements for turkey medical device registration are regulated by the medicines and medical devices agency in Turkey. This procedure consists of the product tracking system (ÜTS), which is the mandatory electronic system where each product should be registered in order to be cleared to enter the market. In 2026 Turkey will harmonize its legislation with EU MDR (2017/745) and IVDR (2017/746). Companies from other countries cannot apply directly but should authorize their representative in Turkey who will control the turkey medical device registration account in ÜTS. The submission dossier should contain documents. This list includes the declaration of conformity, ISO 13485 certificate, the updated technical documentation, product label and Instruction for use (IFU). All documents should be translated to Turkish according to the requirement. After all documents are submitted to the ÜTS system, the turkey medical device registration procedure will take from 60 to 120 days. Speaking about the cost, each year TİTCK presents an annual fee table in Turkish Lira. Although there may be small fees for simple notifications, the manufacturer has to pay a certain Certificate Registration Fee and system maintenance fee.
Middle East Medical Device Registration: Ways Morulaa Can Assist You
Middle East Medical Device Registration should not be an uphill struggle with the paperwork. At Morulaa, we work as your local regulatory authority in managing the whole registration process. From accessing the GHAD portal in Saudi Arabia to working with the Turkish ÜTS portal, we take care of all the steps in the process of registration. We will help in finding your LAR, arranging the ISO 13485 documents and ensuring that all labels have been accurately translated in Arabic/Turkish language. The most important thing for us is to minimize problems and ensure quick delivery of your products to the market.
Is an authorized local representative required for the Middle East Medical device registration ?
Yes. It is impossible to register directly with government authorities. You are required to appoint an authorized local representative in every country where you are registering. For example, in Saudi Arabia it is through the portal GHAD, while ÜTS is the competent authority in Turkey.
Does a CE Mark or FDA approval guarantee registration?
Unfortunately, no. However, it does expedite the registration process. For instance in Kuwait and Qatar, countries that utilize an abridged procedure, your device may take 3-6 months to register if it has pre market approval elsewhere. In Saudi Arabia however, all devices, foreign or domestic, now require a full technical assessment (MDMA2).
What are the language requirements for labeling?
Bilingual labeling is required in Saudi Arabia, Egypt, Kuwait, Qatar. In Turkey all documents must be translated into Turkish. In Saudi Arabia, patient facing documents should be in Arabic and English. The same applies to Egypt, Kuwait, Qatar.