How to Register a Medical Device in Israel

This video gives medical device manufacturers a clear roadmap for entering Israel’s fast-evolving medical technology market. With a market value of USD 2.4 billion (2022) and forecast growth of 2% annually, Israel is a hub for health innovation where universal healthcare coverage and a thriving R&D ecosystem converge. The in-vitro diagnostics (IVD) segment alone is projected to reach USD 475 million by 2025. Combined with one of the world’s highest life expectancies (76.7 years) and an aging population (11.8% over 65), Israel presents growing demand for innovative, reliable, and safe medical devices.

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Topics covered in this video include:

• Israel’s medical device market size, growth trends, and healthcare drivers
• AMAR’s regulatory framework and classification system
• Key requirements for medical device registration and dossier preparation
• The role of an Israeli Representative (IR) in market access and compliance
• How Pure Global streamlines submissions, certification, and post-market obligations
• Strategic benefits of entering Israel’s innovation-driven healthcare market

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Regulatory oversight is managed by the Ministry of Health’s Medical Device Division, known as AMAR. Israel’s framework is closely aligned with US and European standards, but manufacturers must still navigate unique national requirements. Devices are mapped to US-based classifications, and dossiers must be prepared in a format that addresses technical, clinical, and quality evidence. Securing AMAR certification is a prerequisite for placing products on the Israeli market, and once approved, manufacturers must remain compliant with post-market surveillance and reporting obligations.

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Need help with AMAR registration?
Pure Global simplifies Israel’s regulatory pathway by combining global expertise with local presence. Our specialists classify your device correctly, prepare AMAR-compliant documentation, and act as your Israeli Representative to ensure smooth communication with authorities and long-term compliance. With one engagement, you can secure AMAR approval and build a launchpad for scaling innovation across Israel’s health sector and beyond. Learn more about AMAR Israel Medical Device Registration.

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