Israeli Medical Equipment Consulting Servies

Israeli Medical Equipment Consulting Servies



The Israeli Medical Equipment Law, Key Principles

  • Mandatory Registration: Every medical device must be registered in AMAR’s central registry before production, import, or sale.
  • Public Registry: The registry is the official database of approved medical devices in Israel and is accessible to the public.
  • Enforcement and Penalties: Manufacturing, importing, or marketing unregistered devices is a criminal offense.
  • Supervision: The Minister of Health may appoint inspectors to oversee compliance, including inspections of manufacturing and storage facilities.

Main Regulations

  • Fast‑Track Registration: Devices already approved in recognized countries (e.g., U.S., U.K.) may benefit from an accelerated registration process.
  • Storage Requirements: Devices must be stored under proper conditions, such as controlled temperature.
  • Additional Requirements: Manufacturers and subcontractors must comply with ISO 13485, while importers must comply with ISO 9001, and all must hold relevant business licenses.
  • Exemption from Standards Testing: The Minister may exempt imported devices from Israeli standard testing if international compliance documents are provided.
  • Governmental Fees: Since August 15, 2022, no fees are charged for registration, amendments, or renewals.

Enforcement Bodies

  • AMAR (Medical Devices Division): Responsible for device registration, import permits, export approvals, and market surveillance.
  • Ministry of Health: Oversees regulatory enforcement and collaborates with professional committees and the Standards Institute of Israel.


This summary highlights the mandatory registration, compliance obligations, enforcement mechanisms, and regulatory pathways under Israeli law.


📢 Our Services in Israel

Sterling Medical Registration provides comprehensive regulatory consulting in Israel, guiding manufacturers, importers, and distributors through AMAR registration, licensing, and compliance with the Medical Equipment Law. We support fast‑track registration for internationally approved devices, assist with ISO certification requirements, and ensure proper documentation and storage compliance. With our expertise, your medical devices can enter and thrive in the Israeli market with confidence and full regulatory assurance.