Ensuring Compliance with Israel's Medical Device Regulations

Israel, with its advanced healthcare sector and a strong focus on technological innovation, presents a dynamic market for medical devices. The country's regulatory environment is designed to ensure that medical devices entering the market meet high standards of safety and efficacy. As a hub for medical innovation, Israel offers significant opportunities for foreign manufacturers looking to introduce new and advanced medical technologies.

Device Classification and Regulatory Pathways

Aligning with AMAR's Requirements

Regulatory Authority

The Israeli Ministry of Health's Medical Device Division, known as AMAR, is responsible for the regulation of medical devices in Israel. The division oversees the registration, importation, and post-market surveillance of medical devices to ensure public health and safety. Compliance with the Medical Equipment Law, 2012, and the Medical Equipment Regulations (Registration and Renewal of Medical Equipment in the Register), 2013 and AMAR's regulatory requirements is essential for market access and the successful distribution of medical devices in Israel.

Classification

The Israeli Ministry of Health does not maintain its own system of device classification. Instead, it defers to the classification system of a recognized country, as outlined in the Medical Equipment Law. The classification system of the US Food and Drug Administration is typically given priority.

Key Requirements

To market medical devices in Israel, manufacturers must:

  • Ensure compliance with international regulatory standards that Israel recognizes, facilitating smoother entry for devices already approved in major markets.
  • Register their devices with AMAR, providing comprehensive documentation that demonstrates conformity with safety and performance standards.
  • Appoint a local Israeli Representative (IR) if the manufacturer does not have a direct presence in Israel. The IR acts as the liaison with AMAR and oversees the regulatory process.
How We Can Help

Tailored Support for Market Entry

Our expertise facilitates your entry and compliance within the Israeli market:

  • Guidance on device classification and the detailed regulatory pathway for Israel.

  • Preparation and submission of the required documentation for AMAR registration.

  • Acting as your Israeli Representative, managing the registration process and ensuring ongoing compliance with AMAR's regulations.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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