Medical Device and IVD Registration in Israel

In 2024, Israel reformed its medical device and IVD registration processes for low- and moderate-risk devices to increase the accessibility of the Israeli market for foreign manufacturers. By leveraging authorizations in recognized jurisdictions, particularly the US and Europe, device manufacturers can now use simpler registration routes with accelerated timelines.

Israel’s Medical Device Regulatory Framework

Israel medical device registration is overseen by the Ministry of Health’s Medical Device Division, known as AMAR. AMAR enforces two key regulations: the Medical Equipment Law, enacted in 2012, and the Regulations for Medical Equipment Registration. The Law and Regulations are not yet officially implemented, but AMAR typically follows the written requirements in practice. Additionally, guidelines of the Medical Equipment Division for Medical Devices can be found on the Ministry of Health’s website, however at this time, only Hebrew translations are available.

Leverage Existing Approvals for Faster Registration in Israel 

When registering medical devices with AMAR, you don’t need to start from scratch. Devices already approved in recognized countries—including the U.S., Canada, EU, UK, Australia, New Zealand—can benefit from a streamlined process under Israel’s Medical Equipment Law. Israel accepts CE-marked devices under the MDR or IVDR, as long as they are legally placed on the market in an EU member state [1]—regardless of the Notified Body’s country.  

To register a device with AMAR, manufacturers must show that the product is already authorized in at least one of the recognized countries listed in Schedule 1 of the Medical Equipment Law. This means you can leverage existing market authorizations to accelerate your path to AMAR registration. 

Israel does not enforce its own risk classification system for medical devices and IVDs. Instead, it adopts the classification assigned by the device’s selected reference market

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[1] Austria, Italy, Iceland, Ireland, Belgium, Germany, Denmark, The Netherlands, Greece, Norway, Spain, Portugal, Finland, France and Sweden.

Appointing an Israel Registration Holder

Before submitting a registration application, foreign manufacturers must appoint a local regulatory representative known as an Israel Registration Holder (IRH), which serves as the official liaison between the manufacturer and AMAR. The IRH must be an individual or legal entity based in Israel and hold ISO 9001 certification. This role involves submitting registration applications, managing renewals and modifications, and ensuring compliance with post-market obligations, including adverse event reporting and recalls. The IRH must stay up to date with shifting regulatory requirements and should have the capacity to fully support device registration and post-market compliance operations. 

While some companies use distributors as their IRH, designating an independent IRH is often recommended to avoid conflicts of interest, particularly regarding distribution. An independent IRH can also prioritize regulatory responsibilities, protect confidential technical documentation, and offer ongoing support, regardless of changes in distribution partners. 

Medical Device and IVD Registration in Israel

Israel now offers three formal pathways for device registration: Declaration, Fast-Track, and Standard. Each route corresponds to the device’s risk level and the status of regulatory approval in other recognized markets.

Declaration Route – Low-Risk Devices

The Declaration Route is the default registration pathway for Class I medical devices and Class A IVDs. [2] Under this route, manufacturers may register their devices through a self-declaration process, provided the device has already received approval and has been placed on the market in a recognized reference country. This pathway enables immediate or near-immediate registration, as certificates are issued within 48 hours of dossier submission to AMAR.

Fast-Track Route – Eligible Medium-Risk Devices

The Fast-Track Route is an expedited process for moderate-risk devices that meet certain eligibility criteria, and is divided into two sub-pathways [3]:

• Fast-Track Route 1 applies to moderate-risk devices, such FDA Class II or EU MDR Class IIa devices. The device must have authorization in at least one recognized reference country and must have been commercially available there for at least four months prior to the registration in Israel. AMAR’s review timeline is approximately 45 business days.
• Fast-Track Route 2 is designed for slightly higher-risk devices, such as EU MDR Class IIb and EU IVDR Class C devices. These products must have approval in two separate reference countries and must have been on the market in at least one of them for six months or more prior to the registration in Israel. AMAR’s review timeline is approximately 60 business days.

Standard Route – For High-Risk devices or devices without prior authorization Devices that do not meet the criteria for the Declaration or Fast-Track Routes must follow the Standard Route. This includes Class III medical devices, IVDR Class D IVDs, and medium-risk devices without reference market approval or market history (e.g. medical equipment manufactured in Israel and not registered in another market).

The overall process remains consistent with existing Israel medical device registration requirements. However, updated procedural guidance (REG-2024/03) for submission content and format took effect in January 2025. [4] Additional requirements can include risk analyses, clinical evaluations, or clinical trial data (also relevant for Class IIb or Class II that use the Fast-Track). The target AMAR review timeline is 120 calendar days, though actual review timelines can take four to six months, depending on submission quality or device complexity.

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[2] units_amar_guidelines-for-registering-medical-equipment-declaration-route.pdf

[3] REG-2024/06 Instructions for Registration in the Medical Device Register on a Fast-Track

[4] https://www.gov.il/BlobFolder/dynamiccollectorresultitem/registration-procedure-medical-equipment-register_documents-registration/he/units_amar_Registration-procedure-medical-equipment-register_documents-registration.pdf

Documentation Required for AMAR Registration

Registration applications are submitted to AMAR electronically by your IRH. Submission documentation requirements vary depending on the registration route, but can include the following: 

• Application form
• Technical file or dossier (not required for Declaration Route)
• Proof of regulatory approval (e.g., CE certificate, Declaration of Conformity, FDA approval such as Establishment Registration and Device Listing, 510(k) summary)
• Labeling and instructions for use (IFU)
• Certificate to Foreign Government (CFG)/Certificate of Free Sale (CFS)
• Quality management system (QMS) certificate (i.e., ISO 13485:2016) for the legal manufacturer and manufacturing site, as well for the sterilization company (where applicable) if not completed with the manufacturing site.
• Declarations requested by AMAR and other technical documents per the device in question.

Labeling and Language Requirements

Labeling that complies with requirements in the US or the EU is generally accepted. However, home use devices intended for use by laypersons must have labeling in Hebrew, Arabic, and English; [5] professional use-only devices may provide labeling exclusively in English.

Import Permits

To import medical devices into Israel, your IRH must obtain a periodic import permit from AMAR. [6] A periodic import permit is granted only after your device is registered with AMAR and allows for ongoing imports. It must still be renewed before it expires to avoid disruption in distribution or complications at customs. The importer you choose must have at least ISO 9001 certification and a valid business license. These documents are reviewed by the IRH.

Testing

Electro-medical products may require certification from the Standards Institution of Israel (SII). This process often involves submitting technical documentation or existing test results and a physical device sample for assessment. The SII accepts CB certificate, and an EMC repot from accredited testing facilities. [7]

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הנחיות לסימון אביזרים ומכשירים רפואיים – )אמ”ר [5]

[6] https://www.gov.il/he/pages/amr-import

[7] International Recognition Agreements – Standards Institution of Israel

AMAR Registration Validity, Renewals, and Modifications

Registration validity depends on the risk classification and registration route. Devices registered under the Declaration Route must renew annually via a similar notification process. The renewal cycle runs from October 1 through December 31, and any registrations granted before October 1 must still be renewed within that same year.  

Devices approved through the Fast-Track or Standard Route are valid until the reference market approval expires or up to five years, with an exception for implants, which are limited to three years. AMAR will not issue a registration that exceeds the validity of the reference country’s approval. Renewal applications must be submitted at least four months prior to expiration. Renewals can be submitted using the Declaration Route for Class I and Class A IVDs, and renewals for Class IIa and IIb devices and Class B or C IVDs can be submitted via the Fast-Track route. Renewals of Class III and Class D IVDs will be submitted via the Standard Route. High-risk devices and IVDs must compile a renewal submission that includes a post-market report. AMAR has published the guideline REG-2024/07 Procedure for Renewal of Registration in the Medical Device Register, which provides specific details on the renewal process.

Modification submission procedures correspond to the device’s original registration pathway and the nature of the change. Class I and Class A devices can submit modifications via the Declaration Route regardless of the modification’s scope. Devices eligible for Fast-Track registration can also submit modifications using a Fast-Track process, along with certain Class III devices seeking minor or administrative updates. 

REG-2024/08 specifies changes that qualify as modifications (major versus minor) or require a new registration. A new registration is necessary if the intended use changes, the device’s risk classification increases, if the active substance in a combination product is altered, or if a new component is added to a device system. 

Post-Market Surveillance and Vigilance Requirements in Israel

According to Israeli Law and the procedure, the IRH is obligated to report the following to the Minister of Health: 

• Any Unusual Event in the medical device (in Israel or abroad)
• Manufacturer notices of corrective action
• Field safety corrective action (FSN/FSCA) or recall from the market,
• Notices from competent authorities abroad, including notices from the American Food and Drug Administration (FDA).

PMS and vigilance operations should be led by an appropriately qualified person. Reportable events are broadly defined, but generally include:

• Device-related events that have harmed a patient’s health 
• Significant defects that could pose a risk to users 
• A safety communication issued by the manufacturer 
• Actions taken by foreign regulatory authorities
• New safety data published in scientific literature
• A formal risk management system (this may be required for certain high-risk devices and AMAR may request periodic risk–benefit evaluations or impose enhanced monitoring protocols, such as device traceability records)

Register your Medical Device in Israel Today with MedEnvoy

Medical device registration in Israel is more streamlined than ever before, but local expertise is still essential for foreign manufacturers who need help translating AMAR requirements for their specific device or reference market. Through partnerships in Israel, MedEnvoy can act as your Israel Registration Holder and facilitate your market entry, navigate post-market compliance, and ensure you retain full control of your registration and distribution. Contact us today.