Israel, with its advanced healthcare sector and a strong focus on technological innovation, presents a dynamic market for medical devices. AMAR Israel medical device registration requirements are 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.
Israel's medical devices market was $2.4B in 2022, growing at 2% CAGR (2022–2028). The IVD market is set to reach $474.7M by 2025 with a 3.59% CAGR (2025–2029), driven by strong medical innovation.
The Medical Device Division of the Ministry of Health (AMAR) is the medical device regulator in Israel. Pure Global can assist with Israel medical device registration and provide local representation, ensuring AMAR approval to sell in the Israeli market.
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.
To market medical devices in Israel, manufacturers must:
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.
The primary regulatory authority for medical device registration in Israel is AMAR, under the Ministry of Health Israel. Pure Global can assist with navigating the registration process to ensure AMAR approval for selling medical devices in the Israeli market.
Israel does not maintain its own system of device classification. Instead, it defers to the classification system of a recognized country, most commonly the US Food and Drug Administration (FDA). This means that Israel medical device classification typically aligns with devices classified according to FDA standards.
Foreign manufacturers must: Ensure compliance with international regulatory standards recognized by Israel medical device regulations, 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.
Appointing a local Israeli Representative (IR) is crucial for foreign manufacturers because the IR acts as the liaison with AMAR, ensuring compliance with Israeli regulations, facilitating communication, and overseeing the entire process of medical device registration in Israel. This enables the manufacturer to effectively market and sell their medical devices in Israel.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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