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. 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.
Aligning with AMAR's Requirements
Regulatory Authority
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.
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.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in Israel?
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.
How are medical devices classified in Israel?
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.
What are the key requirements for foreign manufacturers to market medical devices in Israel?
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.
Why is appointing a local Israeli Representative important for foreign manufacturers?
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.
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