Israel

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: 4. AMAR reviews document completeness (approximately 1–2 months); may issue a Deficiency Letter
• Key fees: Registration Fees
• Local requirement: 2. Appoint a licensed Israeli Authorized Representative (IAR / נציג מורשה) in Israel
• 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

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