MIDDLE EAST
Our Objective
Our objective in the Middle East is to enable medical device and digital health companies to achieve efficient, compliant, and sustainable market access across a diverse and fast-growing regulatory environment. We aim to simplify regulatory complexity, anticipate evolving requirements, and support our partners with clear strategies, local insight, and end-to-end regulatory support, ensuring that innovative technologies reach patients safely and in full alignment with national health authorities across the region.
Gulf Cooperation Council
Saudi Arabia: Operates under a sophisticated, risk-based regulatory framework managed by the SFDA, requiring mandatory medical device marketing authorization (MDMA) and strict GHTF alignment for all international manufacturers.
United Arab Emirates: Utilizes a highly efficient, innovation-driven registration system via MOHAP, prioritizing rapid market entry through site registration and the recognition of world-class quality standards (CE/FDA).
Qatar: Maintains a quality-centric regulatory environment overseen by the MoPH, emphasizing prior international approvals and rigorous oversight for high-risk and implantable medical technologies.
Kuwait: Follows a structured procurement and registration model through the MoH, requiring comprehensive documentation and strict legalization protocols to ensure the safety of imported medical devices.
Bahrain: Operates an agile and transparent regulatory system under the NHRA, utilizing an integrated digital platform (Meidca) to streamline the oversight of medical consumables and equipment.
Oman: Features a developing regulatory landscape governed by the MOH, focusing on localized distribution compliance and a centralized technical review process for all medical equipment.
Levant
Jordan: Functions as a regional medical hub with a rigorous technical framework managed by the JFDA, emphasizing clinical evidence and detailed technical dossiers for market authorization
Lebanon: Operates a resilient market framework via the MOPH, focusing on product registration and pricing compliance to integrate into the national healthcare reimbursement system.
Syria: Maintains a centralized regulatory oversight through the MoH, focusing on healthcare stabilization and compliance with fundamental medical safety laws during the market entry process.
Palestine: Navigates a unique regulatory environment managed by the MoH, ensuring medical devices meet essential safety standards while coordinating with specific logistical and import protocols
Israel: Offers a tech-forward regulatory pathway through the AMAR unit, featuring expedited « recognition tracks » for devices already cleared by major global regulatory bodies (FDA/CE).
The Middle East is a region of strong growth and strategic opportunities, particularly in healthcare and digital health — yet its regulatory landscape is fragmented and rapidly evolving. Multiple regulatory authorities, country-specific requirements, and different levels of regional alignment mean that successful market access requires deep regional expertise and strong local partnerships.
At Simon MedTech Solutions, we support your expansion across the Middle East with clarity and confidence. From the Gulf Cooperation Council (GCC) to the Levant, our team helps ensure your medical devices and medical software reach patients safely, efficiently, and in full compliance with national regulatory frameworks.
