AMAR Israel Medical Device Registration
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.
Aligning with AMAR's Requirements
Regulatory Authority
Pure Global can assist with Israel medical device registration, ensuring AMAR approval to sell in the Israeli market.
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.
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.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.