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Israel

7 articles

Regulatory

Israel MOH Device Register: 28,800 Devices, 92% Imports, and Importer Concentration

Israel's MOH register lists 28,821 medical devices — 91.8% imported, the US/Germany/China supply 53.6%, and 2,111 importers (IRHs) hold the licence layer.

Labeling & UDI

Arabic Labeling, UDI & Halal Certification for Medical Devices in MENA (2026)

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.

Digital Health & AI

Digital Health & AI Medical Device Regulation in MENA: SFDA, EDE & TITCK Frameworks

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.

IVD & Diagnostics

MENA IVD & Diagnostics Registration: Country-by-Country Requirements

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.

Reimbursement & Market Access

MENA Medical Device Reimbursement and Health Insurance Guide (2026)

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.

Post-Market Surveillance

MENA Post-Market Surveillance & Vigilance: SFDA, EDE & Regional Requirements (2026)

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.

Regulatory

Israel AMAR Medical Device Registration Guide (2026): Fees, Timelines, Requirements

Guide to Israel AMAR medical device registration in 2026, including classification, declaration and fast-track routes, IRH duties, approvals, SII, and labeling.