Israel

Country-by-country labeling requirements for medical devices across MENA — Saudi Arabia (Arabic+English mandatory), UAE (Arabic with equal prominence), Egypt (Arabic or English), Israel (Hebrew+Arabic+English for consumer), Turkey (Turkish for consumer). Halal certification frameworks (GSO 2055-1:2015, SFDA-approved logos, UAE MOIAT, Qatar MOPH). UDI requirements across Saudi Arabia, UAE, Egypt, and Turkey.

Complete guide to digital health and AI medical device regulation across MENA — SFDA MDS-G27 guidance on digital health products (SaMD, mHealth, DTx, AI/ML, telemedicine, wearables, VR/AR), UAE EDE AI registration frameworks and National AI Strategy 2031, Turkey TITCK software medical device classification and exclusion list, Israel AMAR software requirements, and practical compliance strategies for each market.

Complete guide to in vitro diagnostic (IVD) registration across MENA — Saudi SFDA IVD classification (A–D) and companion diagnostic guidance, UAE EDE IVD requirements and fees, Egypt EDA IVD classes with ISO 15189/CLSI performance evaluation, Turkey TITCK IVDR-aligned framework, Israel AMAR IVD declaration route, and point-of-care testing requirements.

How medical devices get reimbursed across MENA — Saudi Arabia CHI/NPHIES/AR-DRG value-based system, UAE mandatory insurance (Daman/Thiqa/AED 320 basic plan), Turkey SGK SUT codes and DMO procurement, Israel Health Basket, and Egypt UHIA universal insurance rollout. Market data, fees, co-payments, and market access strategies for device manufacturers.

Complete guide to post-market surveillance and vigilance requirements for medical devices across MENA — SFDA MDS-REQ11 (2-day/10-day/30-day reporting, change notifications, 90-day renewal), UAE EDE biennial PSUR for high-risk devices, Turkey TITCK 6-month shortage notification, Israel IRH periodic post-marketing reports, and Egypt EDA vigilance obligations.

Everything you need to know about registering medical devices in Israel in 2026 — including AMAR classification, declaration and fast-track routes, Israel Registration Holder (IRH) requirements, reference country approvals, SII certification, labeling in Hebrew, Arabic, and English, and step-by-step registration instructions.