Unveiling Opportunities of Medical Device Distribution in Israel

Navigating Medical Device Distribution and Regulatory Requirements in Israel

The Bottom Line for International Medical Device Manufacturers:
The Israeli medical device sector boasts a net worth of approximately 10 billion dollars annually making it one of the most coveted markets for global manufacturers. However success in this 10 billion dollar landscape depends on a profound understanding of the Israeli Ministry of Health (IMOH) and its Medical Devices Division (AMAR).

By decoupling distribution from registration and engaging an independent Israeli Registration Holder you safeguard your commercial independence and ensure long term compliance in a market that demands the highest standards of safety and quality.

The Israeli healthcare landscape is globally renowned for its cutting-edge innovations, groundbreaking research, and unwavering commitment to delivering top-tier healthcare solutions. The medical device sector in Israel boasts a net worth of approximately 10 billion dollars annually demonstrating rapid growth rates and making it a highly coveted market for medical device manufacturers worldwide.

Why Choose the Israeli Market for Your Medical Device

Before delving into the intricate world of distribution it is important to explore why the Israeli market holds such appeal for medical device manufacturers. Israel’s attributes include a high growth rate, an innovative healthcare system, extensive health insurance coverage, accessibility, and an exceptional quality of life. With around 30 hospitals and numerous private clinics actively engaged in medical device clinical trials, clinical evaluations, performance assessments, and efficacy studies, Israel offers a robust environment for testing and validation. Additionally Israel serves as an ideal hub for clinical trials, performance studies, and commercial distribution.

Navigating the Israeli Medical Device Regulatory Landscape

To successfully enter the Israeli market a profound understanding of the regulatory framework is essential. The Israeli Ministry of Health (IMOH) is the governing body responsible for regulating the entry and circulation of medical devices through its Medical Devices Division (AMAR). AMAR establishes and enforces regulations generally aligned with the European Union Medical Device Regulations (MDR) and the FDA. While the overarching framework takes cues from the MDR it is crucial to recognize that specific Israeli requirements and updates are in place. Staying informed about these nuances with the assistance of local consulting firms or Israeli registration holders is essential for a successful distribution strategy.

The Role of Medical Device Distributors in Israel

Effectively distributing medical devices in Israel demands a comprehensive understanding of the importation process. The journey begins with a thorough risk-based device classification often following a model similar to the European classification method. This classification sets the stage for regulatory compliance and profoundly influences the distribution process. Ensuring that your device complies with the necessary safety and quality standards is of paramount importance. Equally critical is the selection of a local Importer and Registration Holder (IRH). The IRH is mandatory based on IMOH regulatory requirements and must be declared as part of the medical device submission.

The IRH plays a pivotal role in connecting your devices to the Israeli market and ensuring post-marketing compliance with IMOH.

Crafting a Successful Medical Device Distribution Strategy in Israel

Success hinges on a deep understanding of the export requirements set forth by the IMOH. Addressing labeling, documentation, certifications, declarations, and compliance with local standards is pivotal for a smooth distribution process.

On numerous occasions clients have reported that inappropriate distribution companies led to damage to their business activities and reputation. Collaborating with a reliable proficient local partner free from conflicts of interest ensures that your distribution aligns seamlessly with specific regulations.

The Medical Device Distribution Process in Israel

The general steps involved in the medical device distribution process in Israel are outlined below:

Step 1: Device Classification

Conducting a detailed design FMEA risk assessment
Defining clear intended use
Determining the appropriate risk class

Step 2: Technical Documentation

Define and document the device design
Define and document the manufacturing process
Evaluate the performance, safety, and efficacy of the device
Ensure that the device labeling and instructions for use align with IMOH guidelines

Step 3: Quality Management System (QMS)

Verify that the device manufacturer holds a valid ISO 13485 certification
Verify that your local registration holder has a valid ISO 9001 certification to manage the interphase between the manufacturer and the IMOH regarding safety and quality

Step 4: Conformity Assessment

Complete verification of the technical documentation
Perform Verification and Validation (V&V)
Assess the quality management system

Step 5: Application Submission

Prepare and apply for distribution to the Israeli Ministry of Health while attaching all required documentation and paying relevant government fees.

Step 6: Review and Approval

The IMOH will review the distribution application and supporting documentation ensuring compliance. If approved the medical device can be distributed in the Israeli market.

Step 7: Post Market Surveillance

Once the device is on the market its performance should be monitored. The local Israeli registration holder will work closely with the IMOH to collect, investigate, and report any adverse events.

Step 8: Distribution Renewal

Registration and distribution licenses in Israel are subject to renewal. Adhering to renewal requirements is essential to continue distributing your medical device effectively.

Choosing the Right Medical Device Distribution Partner in Israel

While having a local distribution partner is a regulatory requirement entrusting this responsibility to a reliable consulting firm offers significant advantages. Opting for a neutral company with professional regulatory capabilities ensures long-term reliability and efficient collaboration with IMOH personnel. This mitigates potential business risks that may arise from conflicts of interest with local entities like medical distribution companies or warehouses.

Frequently Asked Questions

Is ISO 13485 required for all medical device manufacturers entering Israel?
Yes. The IMOH requires that the manufacturer demonstrates the ability to consistently produce safe and effective devices through a valid ISO 13485 certification.

Does the Israeli Ministry of Health follow FDA or MDR rules?
The IMOH generally aligns its regulations with both the EU Medical Device Regulation (MDR) and the FDA but it maintains specific Israeli requirements and updates that must be addressed in the technical file.

What is the benefit of an ISO 9001 certified Registration Holder?
An ISO 9001 certification for your Israeli Registration Holder ensures that the interface between your company and the IMOH is managed with high quality standards regarding change management and device safety.