Medical Device Registration and Submissions in Israel

Strategic Guide to Medical Device Registration and IRH Services in Israel

The Bottom Line for Global Medical Device Manufacturers:
Israel is a high-growth, innovation-driven healthcare market that relies heavily on international standards. As of 2025-2026 the Ministry of Health (AMAR) has fully implemented a new tiered registration system. For Class I and certain Class II devices with existing FDA or EU MDR approval you can now utilize the Declaration or Fast-Track routes, significantly reducing time-to-market. However these expedited tracks increase the legal burden on your Israeli Registration Holder (IRH), who must now maintain a comprehensive “state of control” and manage real-time post-market vigilance. Appointing an independent, professional IRH is the most effective way to protect your regulatory assets and ensure continuous market access.

The regulatory body responsible for medical device registration, submissions, and supervision in Israel is the Medical Device Division of the Ministry of Health, known as AMAR. This division oversees the manufacture, assembly, sterilization, and marketing of all medical devices, including implants, software as a medical device (SaMD), and combination products. AMAR grants import permits and publishes the guidelines that facilitate the entry of foreign-manufactured technology into the Israeli healthcare ecosystem.

Global Recognition and Classification

Israel does not maintain a unique classification system but recognizes the risk levels assigned by GHTF countries.

If your device has documented evidence of approval from one of the following authorities the registration process is streamlined:

US FDA — 510(k) clearance or PMA approval
European Union — CE mark certificate under MDR 2017/745 or IVDR 2017/746
Certificate of Free Sale (CFS) — From a recognized reference country (e.g. Canada, Australia, Japan)

The 2026 Expedited Registration Tracks

To reduce bureaucracy and lower the cost of living Israel has introduced three primary registration pathways based on risk level and existing global approvals:

Registration Route	Applicable Device Class	Estimated Review Timeline
Declaration Route	Class I / Class A IVD	Immediate (Self-Declaration)
Fast-Track Route 1	Medium-Risk (e.g. FDA Class II, EU Class IIa)	45 Business Days
Fast-Track Route 2	Medium-High Risk (e.g. EU Class IIb)	60 Business Days
Standard Route	High-Risk (Class III) or No Foreign Approval	120+ Business Days

The Essential Role of the Israeli Registration Holder (IRH)

According to Israeli Medical Device Law the registration “owner” for a foreign manufacturer must be a local agent established in Israel. This Israeli Registration Holder (IRH) functions similarly to an EU Authorized Representative or US Agent.

The IRH must be an Israeli citizen or a local corporation and must maintain ISO 9001:2015 certification.

Primary IRH Responsibilities

The IRH is your primary liaison with AMAR and is legally responsible for the following activities:

Preparation and submission of all registration dossiers via the AMAR SAFE portal
Verification of the first batch of devices marketed in Israel
Reporting of global and local adverse events to the Ministry of Health
Timely renewal of registrations to prevent supply chain disruptions
Maintenance of the Technical File and ISO 13485 manufacturer certifications

Additional Standards and Labeling Requirements

Beyond AMAR approval certain electro-medical devices require validation from the Standards Institution of Israel (SII) under the SI 60601 series. This ensures electrical safety and electromagnetic compatibility (EMC) within the Israeli power grid. Furthermore labeling requirements depend on the end-user:

Domestic Use — Labeling and Instructions for Use (IFU) must be in Hebrew, Arabic, and English.
Professional Use — Devices used only within health facilities may provide labeling in English only.

Post-Market Vigilance and Renewals

Registration validity typically lasts for five years (two years for implants) but cannot exceed the validity of the reference country’s certificate.

The IRH must submit a renewal dossier at least four months prior to expiry.

Under the 2026 guidelines the IRH is also mandated to prepare periodic post-marketing reports and monitor global restrictions from other regulatory bodies that might affect the device’s safety profile in Israel.

Frequently Asked Questions

Can my distributor act as my IRH?
While legally possible it is strategically risky. Using a distributor as an IRH ties your registration to a commercial partner. If you wish to switch distributors you may face a “hostage” situation with your license. An independent IRH allows you to change distributors without affecting your market approval.

Is the EU MDR certificate accepted in Israel?
Yes. Israel fully recognizes EU MDR and IVDR certifications. In fact the current reform is designed to align Israeli standards with European regulation to allow for faster import tracks.

Do I need to submit clinical data for a Class II device?
If the device has FDA or CE approval you generally do not need to submit raw clinical data for the Fast-Track. However you must provide the Clinical Evaluation Report (CER) summary and a risk analysis as part of the technical dossier.

Contact Eran Yona for IRH and AMAR Registration Services

Accelerate your entry into the Israeli medical device market with expert regulatory support.

We provide independent IRH services, dossier preparation, and SII certification management to ensure your technology reaches patients swiftly and compliantly.