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Israel

Market Overview Population: Approximately 9.5 million (2024) Healthcare System: Universal mandatory health insurance (the Kupot Holim system — four major health funds: Clalit, Macc...

Updated: 2026-05-04

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Reference approval strategy

FDA / CE / MDSAP / NMPA benefits for this market

These factors can reduce evidence-building work, support review confidence, or shape the filing strategy. They do not automatically replace local registration.

US FDA

510(k) / De Novo / PMAStrong benefit

FDA evidence can materially improve review confidence and may support verification, abridged, or reliance-style pathways.

Likely benefit
  • Use FDA review summaries, clearance or approval letters, test reports, clinical evidence, and software or electrical-safety files as support.
  • May reduce technical questions when the intended use, model scope, and evidence package match the local filing.
Limit
  • Does not remove local holder, language, labeling, fee, import, or post-market obligations.
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EU CE

MDR / IVDRStrong benefit

CE documentation is highly reusable and may support reference, reliance, or overseas conformity assessment routes.

Likely benefit
  • Reuse MDR/IVDR technical documentation, clinical evaluation, ISO testing, GSPR or essential-principles mapping, labeling, and PMS evidence.
  • Often helps build CSDT, IMDRF, or local-format technical files faster.
Limit
  • Does not replace local registration or local representative responsibilities outside the CE-recognized route.
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MDSAP

Single QMS auditIndirect QMS signal

MDSAP mainly supports ISO 13485/QMS maturity and does not reduce product review directly.

Likely benefit
  • Reduce duplicate quality-system audits and support ISO 13485, CAPA, complaints, supplier controls, design controls, and production controls.
  • Most useful when the market accepts MDSAP directly or when the application depends on QMS maturity.
Limit
  • Does not authorize product sale and does not replace safety, performance, or clinical evidence.
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China NMPA

China registration / filingDossier reuse only

The NMPA certificate itself has limited effect, but ISO/IEC-aligned test reports, clinical evidence, risk files, and PMS data can be reused after gap assessment.

Likely benefit
  • Use NMPA approval as prior-registration evidence, China market history, and product-maturity support.
  • Convert ISO/IEC-aligned testing, clinical, risk-management, and PMS documents from the NMPA file into the local dossier.
Limit
  • Do not assume automatic recognition; China-only GB/YY evidence may need retesting or restructuring.
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AI Citation Summary

  • Country: Israel
  • Product line: Medical devices
  • Regulator / source: Market Characteristics: A high-technology medical market with high per capita healthcare expenditure; a significant proportion of private hospitals and outpatient clinics; strong demand for innovative medical devices; a well-developed domestic medical technology industry (numerous startups and multinational R&D centers); regulatory quality aligned with Europe and the United States
  • Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
  • Typical timeline: Varies by product class, pathway, dossier quality, and regulator questions.
  • Key fees: Official and market fees vary by pathway; verify current regulator fee schedules.
  • Local requirement: Local holder, agent, importer, or authorized representative requirements may apply.
  • Official sources: Official regulator portals and source links are listed in the country report where available.
  • Last verified: 2026-05-04
  • Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
  • Preferred citation: MedTech Atlas

Market Overview

  • Population: Approximately 9.5 million (2024)
  • Healthcare System: Universal mandatory health insurance (the Kupot Holim system — four major health funds: Clalit, Maccabi, Meuhedet, Leumit), with coexisting public and private sectors and extremely high coverage rates
  • Market Characteristics: A high-technology medical market with high per capita healthcare expenditure; a significant proportion of private hospitals and outpatient clinics; strong demand for innovative medical devices; a well-developed domestic medical technology industry (numerous startups and multinational R&D centers); regulatory quality aligned with Europe and the United States
  • Regulatory Maturity: Highly mature; the regulatory framework is benchmarked against EU MDR; broadly recognizes FDA 510(k)/PMA and EU CE marking as reference market approvals

Regulatory Authority

  • Competent Authority: Ministry of Health of Israel (MOH / משרד הבריאות), through the Medical Technology, Cosmetics and Non-Ionizing Radiation Division (MTCNIR); specific registration matters are handled by AMAR (Agaf Meizug Rishum / אגף מאיזון רישום — the Medical Device Registration Directorate)
  • Official Portal: https://www.health.gov.il/English/Topics/MedicalEquipment/Pages/default.aspx (English); AMAR online submission system: https://amar.health.gov.il
  • Key Regulations:
    • Medical Devices Law 5772-2012
    • Medical Devices Regulations 5774-2014
    • MOH Circulars / Director General Circulars: continuously updated technical requirements
    • IVDs are separately regulated under the In Vitro Diagnostic Devices Regulations

Device Classification System

Local Class Risk Level EU/FDA Equivalent Description
Class 1 Low risk EU Class I / FDA Class I General devices; some exempt from registration
Class 2 Low-medium risk EU Class IIa / FDA Class II Registration required; eligible for reference market fast-track pathway
Class 3 Medium-high risk EU Class IIb / FDA Class II–III Full technical review required; may leverage reference market approvals
Class 4 High risk EU Class III / FDA Class III (PMA) Highest review level; strong clinical evidence required

IVDs have an independent classification system, divided into Classes A/B/C/D following the EU IVDR framework.

Registration Pathways

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