Middle East

A comprehensive guide to Saudi Arabia's SFDA MDS-G27 (2025) regulation on digital health. Understand the boundary between medical devices and wellness software.

MENA medical device labeling guide covering Arabic language rules, UDI requirements, halal certification, and country expectations for Saudi Arabia, UAE, Egypt, Israel, Turkey, and Qatar.

Guide to digital health and AI medical device regulation in MENA, covering Saudi SFDA, UAE EDE, Turkey TITCK, Israel AMAR, SaMD, mHealth, DTx, and compliance strategy.

Guide to Egypt EDA medical device registration in 2026, covering EU MDR-aligned classification, the MeDevice portal, ERH requirements, fees, timelines, and simplification measures.

Register medical devices in Qatar, Kuwait, Bahrain, and Oman, including Kuwait Decree 387/2025, Bahrain NHRA, Oman MOH, Qatar MOPH, and GCC alignment.

Compare IVD registration requirements across MENA, including Saudi SFDA, UAE EDE, Egypt EDA, Turkey TITCK, Israel AMAR, companion diagnostics, performance evidence, and point-of-care rules.

Compare MENA medical device clinical trial requirements, including Saudi SFDA, UAE, Egypt, Turkey, Israel, Qatar, authorization routes, evidence expectations, and multi-country trial planning.

Plan MENA medical device import, customs, and free zone strategy, including GCC tariffs, Saudi SABER and ZATCA, UAE EDE, Egypt EDA, Turkey TITCK, and duty optimization.

Analyze the 2026 MENA medical device market, including regional size, Saudi investment, GCC transactions, UAE and Egypt growth, digital health trends, and smart device demand.

Compare MENA medical device reimbursement systems, including Saudi CHI and NPHIES, UAE Daman, Turkey SGK, Israel Health Basket, Egypt UHIA, co-payments, and market access strategy.

Compare MENA post-market surveillance and vigilance rules for devices, including Saudi SFDA, UAE EDE, Turkey TITCK, Israel IRH, Egypt EDA, reporting timelines, PSURs, and shortage notices.

UAE medical device registration guide under EDE, covering classification, fees, LAR requirements, DHA/DOH differences, and the post-MOHAP transition process.

How to register medical devices in Saudi Arabia, UAE, and the GCC — SFDA requirements, UAE regulatory framework, GCC harmonization, and practical market entry guidance.