Simplifying Medical Device Registration in Israel: Partner with Trusted Israeli Registration Holder Services

When it comes to medical device registration in Israel, it’s crucial to navigate the regulatory landscape with precision and expertise in general and to hire the right local Israeli Registration Holder (IRH) in particular.

The Israeli Ministry of Health (IMOH) is the authority responsible for overseeing the registration process and ensuring the safety and quality of medical devices.

In this blog post, we will delve into the significance of Israeli Registration holder services and the responsibilities they entail.

Understanding Israeli Ministry of Health Regulations

The IMOH, through its Medical Devices Division, establishes and enforces regulations that align with the European Union’s Medical Device Regulations (MDR).

While the overarching framework draws inspiration from the MDR, it’s important to note that specific requirements and updates tailored to Israel exist. Staying informed about these nuances is essential for successful medical device submission.

For more information about medical device registration in Israel- Click here.

The Role of the Israeli Registration Holder

The Israeli Registration Holder (IRH) serves as the local representative for medical device companies operating outside of Israel.

This individual or entity plays a critical role in compliance and regulatory affairs.

Here are the key responsibilities of an Israeli Registration Holder:

IRH Responsibility	Details
Approval and Connectivity	The IRH must be approved and connected to the “AMAR SAFE” software, facilitating streamlined communication with the IMOH.
Global Adverse Event Reporting	Reporting adverse events and non-conformities of medical devices worldwide is a crucial responsibility to ensure continuous monitoring and compliance.
Valid ISO 9001 Certificate	Holding a valid ISO 9001 certificate demonstrates a commitment to quality management systems and adherence to international standards.
Monitoring and Reporting	The IRH is responsible for monitoring, collecting, and reporting adverse events and non-conformities specific to the device in Israel.
Collaboration with IMOH	In cases of non-conformities, out-of-specification incidents, complaints, deviation investigations, or recalls, the IRH works directly with the IMOH to address and resolve these matters.
Communication of Changes	Keeping the IMOH updated regarding any changes that may impact the safety or quality of the medical device, such as modifications in materials, equipment, technology, packaging, storage, or distribution, is essential.
In-house Pharmacist	It is required to have an in-house pharmacist in charge, approved by the IMOH, ensuring compliance with pharmaceutical regulations.

The Medical Device Registration in Israel

To provide a comprehensive understanding, let’s outline the general steps involved in the medical device registration process in Israel:

Medical device submission step	IMOH requirements
Classification	The classification will dictate the regulatory requirements and the level of scrutiny for the registration process: Complete a detailed design FMEA risk assessment Define a clear intended use. Who is going to use the device, and how Determine the appropriate risk class/level of the device
	Prepare a comprehensive Technical File Define and document the device’s design Define and document the device’s manufacturing process, performance Define and document the device’s performance Assess the safety and efficacy of the device Design medical device labeling and instructions for use based on IMOH Does the medical device include Software? Does the medical device include Electrical components? Does the medical device generate Radiation? Does the medical device need Sterilization?
Quality Management System	Implement and maintain a QMS that complies with international standard Verify the device manufacturer holds a valid ISO 13485 certification Verify the QMS demonstrates the ability to consistently produce a safe device Verify the QMS has the ability to consistently produce an effective medical
Conformity Assessment	Evaluate the device’s conformity with the applicable requirements Complete verification of the technical documentation Verification & Validation Assessment of the quality management system
Application Submission	Prepare and apply for registration to the Israeli Ministry of Health Attach all required documentation Pay the relevant government fees.
Review and Approval	The MOH will review the application and supporting documentation The MOH will ensure compliance with the application If approved, the medical device will be registered with a unique IDN The registration period will be up to 5 years (implants up to 2 years)
Post-Market Surveillance	Once the device is on the market, performance should be monitored The local Israeli registration holder will work in front of the IMOH Israeli registration holder will work on behalf of the device’s manufacturer Collect, investigate, and report any adverse events Comply with post-market surveillance requirements
Medical device registration renewal	The registration period for the medical device is limited to up to 5 years Medical device exporter will renew the registration license

For more information about medical device registration in Israel- Click here.

Choosing a Reliable Israeli Registration Holder

While having an Israeli Registration holder is a basic regulatory requirement, entrusting this responsibility to a local Israeli consulting firm can bring numerous advantages. Opting for a neutral company with professional regulatory capabilities ensures long-term reliability and efficient collaboration with IMOH personnel and procedures. This mitigates potential business risks that may arise from conflicts of interest with local entities like medical distribution companies or warehouses.

That’s why it is recommended to hire Israeli Registration holder services from a neutral company, such as a local Israeli consulting firm that will reliably supply these services for the long run and, on the other hand, will have the professional regulatory capabilities to work efficiently with the IMOH personnel and procedures.

Navigating the Israeli medical device registration process requires expertise, adherence to regulations, and effective collaboration with the Israeli Ministry of Health.

By engaging the services of a reputable Israeli Registration Holder (IRH), medical device companies can ensure compliance, efficient communication, and peace of mind as they bring their devices to the Israeli market.

For Medical Device Registration in Israel and Israeli Registration Holder services- Contact me