The Crosswalk

    AMAR / MoH

    Flag of IsraelIsrael — AMAR / MoH

    MandatoryLast updated · 2024 (MoH cybersecurity circular refresh)Verified · 2026-05-28

    Medical Devices Law 5772-2012 + MoH Cybersecurity Circular

    Authority

    Medical Devices Division (AMAR), Israeli Ministry of Health

    Enforced

    2019 (cybersecurity circular)

    Legal framework

    Medical Devices Law + MoH Director-General Circulars + INCD guidance

    FDA package reuse

    ~90%

    Scope

    All medical devices marketed in Israel; reference jurisdiction model accepts FDA, CE, Health Canada, TGA, PMDA approvals.

    Pre-market

    Cybersecurity risk management dossier, threat model, evidence of secure SDLC, alignment to FDA/IMDRF accepted.

    Post-market

    Adverse-event and cyber-incident reporting to MoH; coordination with INCD for critical infrastructure.

    SBOM

    Recommended

    Strongly encouraged; aligned to FDA expectations for dual-market devices.

    Vulnerability disclosure

    INCD (Israel National Cyber Directorate) coordinated disclosure recommended.

    Penalty

    Registration suspension, recall orders, criminal liability under Medical Devices Law.

    Unique requirements

    • 01Israeli Registration Holder required
    • 02Hebrew labelling for end users
    • 03INCD critical-infrastructure notifications for hospital systems

    Highlights

    • Reference-jurisdiction abridged route
    • INCD overlay for hospital-deployed devices
    • Strong alignment to FDA SPDF

    Aligns with

    FDA 2023 Guidance IMDRF N60 IEC 81001-5-1

    Timeline

    1. 2012

      Medical Devices Law enacted

    2. 2019

      MoH cybersecurity circular issued

    3. 2023

      Updated alignment with FDA / IMDRF

    Key documents

    Related markets

    Frequently asked about Israel

    Is SBOM required for medical devices in Israel?

    Recommended. Strongly encouraged; aligned to FDA expectations for dual-market devices.

    What does AMAR / MoH require for pre-market cybersecurity?

    Cybersecurity risk management dossier, threat model, evidence of secure SDLC, alignment to FDA/IMDRF accepted.

    What are the post-market cybersecurity obligations under AMAR / MoH?

    Adverse-event and cyber-incident reporting to MoH; coordination with INCD for critical infrastructure.

    What is the penalty for non-compliance with AMAR / MoH cybersecurity rules?

    Registration suspension, recall orders, criminal liability under Medical Devices Law.

    How much of my FDA cybersecurity package is reusable in Israel?

    Roughly 90% — an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).