Israel AMAR Medical Device Registration Guide (2026): Complete Process, Fees, Timelines & Requirements

Overview of Israel's Medical Device Market

Israel's medical device market was valued at approximately $2.4 billion in 2022, growing at a CAGR of 2% (2022–2028). The IVD market is projected to reach $474.7 million by 2025 with a CAGR of 3.59%. With a life expectancy of 76.7 years and an aging population of 11.8%, Israel presents a dynamic, innovation-driven healthcare market that relies heavily on imported medical technology.

Israel is unique in that it is both a major medical device consumer and a global hub for medical technology innovation. The country's healthcare system is anchored by four major Sick Funds (health maintenance organizations) — Clalit, Maccabi, Meuhedet, and Leumit — which serve as the primary purchasers of medical devices for hospitals and clinics. Getting your device listed on the Sick Fund formularies is a commercial necessity beyond the regulatory registration.

Medical devices are regulated by the Medical Device Division of the Israeli Ministry of Health, known as AMAR (Agaf Mshmeret Briut — Health Protection Department). The regulatory framework is governed by the Medical Equipment Law of 2012 and the Regulations for Registration and Renewal of Medical Devices 2013.

A defining feature of Israel's system: AMAR does not maintain its own classification system. Instead, it defers to the classification of a recognized reference country — typically the US FDA classification is given priority.

Regulatory Framework

Key Legislation

Regulation	Date	Purpose
Medical Equipment Law	2012	Primary legislation for medical device regulation in Israel
Regulations for Registration and Renewal of Medical Devices	2013	Detailed registration requirements, documentation, and timelines
REG-2024/03 (Updated Submission Guidance)	January 2025	Updated procedural guidance for submission content and format
REG-2024/06 (Fast-Track Instructions)	2024	Instructions for registration in the Medical Device Register via fast-track
REG-2024/07 (Renewal Guidance)	2024	Renewal and modification requirements for registered devices
2023 AMAR Scheme (Declaration Route)	August 2023	Introduction of self-declaration route for low-risk devices

Regulatory Authority

AMAR — Medical Device Division, Ministry of Health. AMAR is responsible for:

• Registration of all medical devices and IVDs
• Licensing and supervision of medical equipment
• Import permit issuance
• Post-market surveillance and vigilance
• Publishing guidelines and procedures

AMAR can be contacted at: call.habriut@moh.health.gov.il or by phone at *5400 (Call HaBriuth) / 08-6241010.

Additional Regulatory Bodies

Body	Role
Standards Institution of Israel (SII)	Certification for certain electro-medical devices (SI 60601 series)
Sick Funds (Clalit, Maccabi, Meuhedet, Leumit)	Health insurance entities that list and reimburse medical devices

Device Classification

Israel does not maintain its own classification system. Instead, AMAR adopts the classification of a recognized reference country — with US FDA classification typically given priority.

Israeli Classification	Equivalent (US FDA / EU)	Risk Level
Class I	FDA Class I / EU Class I	Low risk
Class II	FDA Class II / EU Class IIa–IIb	Low to medium risk
Class III	FDA Class III / EU Class III	High risk

AMAR also recognizes IVDR classification (A, B, C, D) for in vitro diagnostic devices.

Classification Principles

• AMAR adopts the risk classification from the reference country where the device is approved
• If a device is approved in multiple reference countries, the highest classification may apply
• The classification determines the registration route, review timeline, and renewal requirements

Registration Routes

Israel offers three registration routes based on device risk level and prior approval in recognized reference countries. All routes require prior approval in at least one reference country — there is no standalone Israeli assessment pathway.

Route 1: Declaration Route (Immediate)

Parameter	Details
Eligible devices	Class I devices (and IVDR Class A IVDs)
Key requirement	Device already approved and marketed in a recognized country
Review timeline	Immediate (self-declaration)
Fees	Waived — no fees for new, renewal, or change applications for Class I
Renewal	Annual via declaration (October 1 – December 31 cycle)

The declaration registration file includes up to 7 files: submission letters, regulatory approvals, manufacturer documentation, labeling, declarations, and supporting documents. This route was introduced in August 2023 and has significantly simplified Class I registration.

Route 2: Fast-Track Route (45–60 Business Days)

Parameter	Details
Eligible devices	Class II (medium risk) and certain Class IIb devices
Fast-Track 1	FDA Class II devices cleared via 510(k) and marketed in US for 4+ months → 45 business days
Fast-Track 1	EU Class IIa devices (incl. IVDR Class B) approved in EU for 4+ months → 45 business days
Fast-Track 2	EU Class IIb devices (incl. IVDR Class C) approved in both EU and US for 6+ months → 60 business days
Fees	Varies; lower than standard route
Renewal	Via Fast-Track route

Key condition: The device must be already marketed in the reference country for the specified period (4 or 6 months).

Route 3: Standard Route (120+ Business Days)

Parameter	Details
Eligible devices	Class III (high risk) and devices without reference country approval
Review timeline	120 calendar days (actual timelines can extend to 4–6 months)
Additional requirements	Risk analysis, clinical evaluation, and potentially clinical trial data
Fees	Higher than fast-track; registration fee was NIS 1,200 (historically)
License validity	5 years (3 years for implants), cannot exceed reference country approval validity

Summary of Registration Routes

Route	Device Class	Timeline	Reference Approval Required
Declaration	Class I / IVDR Class A	Immediate	Yes (from any recognized country)
Fast-Track 1	FDA Class II / EU Class IIa	45 business days	Yes (4 months market history)
Fast-Track 2	EU Class IIb	60 business days	Yes (6 months, both EU and US)
Standard	Class III / no prior approval	120 calendar days	Yes (for reference countries)

Recognized Reference Countries

AMAR accepts prior approval from the following recognized countries:

Americas: United States, Canada

Europe: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom

Asia-Pacific: Australia, New Zealand, Japan

Additional: All CE Marking Certificates issued under the Medical Devices Regulation (2017/745, MDR) are accepted.

Israel Registration Holder (IRH)

All foreign manufacturers must appoint an Israel Registration Holder (IRH). This is mandatory — you cannot submit directly to AMAR.

IRH Requirements

The IRH must be:

• An Israeli citizen or a corporation established in Israel
• ISO 9001 certified (this is a legal requirement, not just a recommendation)

IRH Responsibilities

• Submits registration applications to AMAR on behalf of the manufacturer
• Manages renewals and modifications
• Maintains post-market vigilance — including monitoring global restrictions from other regulatory bodies
• Prepares periodic post-marketing reports
• Acts as the primary liaison with AMAR
• Holds the registration license

Choosing an IRH

Critical advice: Do NOT use your distributor as your IRH. While legally possible, this is strategically risky. Using a distributor as your IRH ties your registration to a commercial partner. If you wish to switch distributors, you may face a "hostage" situation where your market approval is controlled by a commercial entity you no longer work with. An independent IRH allows you to change distributors without affecting your market approval.

Required Documentation

For All Routes

• FDA 510(k) clearance or PMA approval letter, or CE marking certificate under MDR/IVDR
• Certificate to Foreign Government (CFG) or Certificate of Free Sale (CFS)
• ISO 13485 certificate (or equivalent recognized GMP certification)
• Device description and intended use
• Proposed labeling and information leaflets
• Manufacturer and production site details

Additional for Standard Route (Class III)

• Risk analysis
• Clinical evaluation report
• Clinical trial data (if applicable)
• Summary of clinical investigations

Additional for Certain Devices

• SII certification — certain electro-medical devices require validation from the Standards Institution of Israel under the SI 60601 series. This covers electrical safety and electromagnetic compatibility (EMC) within the Israeli power grid. SII accepts CB certificates and EMC reports from accredited testing facilities, and may require a physical device sample.
• Device samples — Sick Funds may request device samples for their own evaluation and potentially require product testing within Israel

Labeling and Language Requirements

Israel has specific multilingual labeling requirements that differ from most other markets:

Professional-Use Devices

• Labeling may be provided in English only
• Safety-related information must still be accessible

Home-Use / Layperson Devices

• Labeling must be provided in three languages: Hebrew, Arabic, and English
• This includes the product label, instructions for use, and all patient-facing documentation

Required Labeling Elements

• Trade name of the product
• Purpose of use and indications
• Name of manufacturer and country of manufacture
• Name and address of the registrant, including telephone number
• Warnings and restrictions
• "Please consult the leaflet before use" (in applicable languages)
• Production batch number or serial number
• Expiry date (if applicable)
• Statement if the device also contains a medicinal product

Fees

Item	Cost
Class I Declaration Route	Free — fees waived for new, renewal, and change applications
Class II Fast-Track	Reduced fees (contact AMAR for current schedule)
Class III Standard Route	Historically NIS 1,200 (~$330); may vary by device type
SII Certification (if applicable)	Varies by device; additional testing costs
IRH Fees (annual)	$3,000–$10,000 (varies by service scope)
Consultant/Regulatory Support	$5,000–$20,000 (depending on route and device complexity)

Total Estimated Cost to Market

Route	Government Fees	IRH + Consultant	Total Estimated
Class I (Declaration)	$0	$3,000–8,000	$3,000–8,000
Class II (Fast-Track)	~$300–500	$5,000–15,000	$5,300–15,500
Class III (Standard)	~$500–1,000	$10,000–25,000	$10,500–26,000

Registration Validity, Renewals, and Modifications

Registration Validity

Device Type	Validity
Standard devices (Declaration & Fast-Track)	5 years, but cannot exceed reference country approval validity
Implants	3 years
IVDR devices	Per IVDR class rules

AMAR will not issue a registration that exceeds the validity of the reference country's approval.

Renewals

• Renewal applications must be submitted at least 4 months prior to expiration
• Class I: Renewal via Declaration Route
• Class IIa/IIb and IVDR Class B/C: Renewal via Fast-Track Route
• Class III and IVDR Class D: Renewal via Standard Route, including post-market report

Declaration Route annual renewal cycle: Runs from October 1 through December 31. Any registrations granted before October 1 must still be renewed within that same calendar year.

Modifications

• Non-significant changes: Submitted via declaration
• Significant changes: Require registration within 60 days
• Significance of changes is assessed using MDCG 2020-3 (for non-IVDs) and MDCG 2022-6 (for IVDs)

Step-by-Step Registration Process

For Class II/III Devices (Fast-Track or Standard Route)

Step 1: Appoint an IRH (2–4 weeks)

• Select an independent, ISO 9001-certified Israeli entity
• Sign a registration holder agreement
• Ensure the IRH has experience with your device type

Step 2: Gather Documentation (4–8 weeks)

• Compile reference country approval documents (FDA, CE, etc.)
• Obtain Certificate of Free Sale / Certificate to Foreign Government
• Prepare device description, labeling, and IFU
• Translate home-use labeling into Hebrew and Arabic (if applicable)
• Obtain SII certification if required for your device type

Step 3: Submit Application via IRH (1–2 weeks)

• IRH compiles and submits the electronic dossier to AMAR
• Application format: Paper and electronic

Step 4: AMAR Review (45–120 calendar days)

• Declaration Route: Immediate
• Fast-Track 1: 45 business days
• Fast-Track 2: 60 business days
• Standard Route: 120 calendar days
• AMAR may request additional information during review

Step 5: Registration Granted

• Device is listed in the Israeli Medical Device Register
• Registration certificate issued to the IRH

Step 6: Sick Fund Listing (Commercial Step)

• Submit to the relevant Sick Fund(s) for formulary inclusion
• Sick Funds may request device samples and/or local testing
• This step is essential for commercial success — hospitals and clinics order through Sick Funds

Step 7: Ongoing Compliance

• Submit renewals on time (4 months before expiry)
• Report adverse events and field safety corrective actions to AMAR
• Monitor global regulatory actions that may affect device safety profile

For Class I Devices (Declaration Route)

Step 1: Appoint IRH

Step 2: Prepare declaration file (7 folders: submission letters, regulatory approvals, manufacturer details, labeling, declarations, supporting documents)

Step 3: Submit to AMAR — registration is immediate upon declaration

Step 4: Annual renewal via declaration (October–December cycle)

Key 2026 Updates

1. Updated Submission Guidance (REG-2024/03, Effective January 2025)

Updated procedural guidance for submission content and format. Manufacturers should ensure their dossiers comply with the new format requirements.

2. Fully Implemented Tiered Registration System

The AMAR scheme introduced in August 2023 — with its Declaration, Fast-Track, and Standard routes — is now fully operational. Class I devices benefit from immediate registration, and Class II devices with prior approval can use the 45-day or 60-day fast-track pathways.

3. Expanded Fast-Track Eligibility

AMAR has explored expanded fast-track criteria. Some sources report that Class II devices with approval from two recognized countries and six months of market data may qualify for accelerated processing, though this pathway is not uniformly documented across all authoritative sources.

4. Increased IRH Post-Market Burden

Under the 2025–2026 guidelines, IRHs are now 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.

5. MDR Transition Recognition

AMAR continues to accept CE certificates under the legacy EU Directives (MDD/IVDD) during the EU transition period, provided specific conditions are met — including a signed contract with a Notified Body and an implemented quality management system.

Practical Tips

1. Get US or EU approval first: Israel's entire registration system is built on reference country approvals. Without FDA clearance or a CE certificate, you face the longest review timelines and the most documentation requirements.

2. Appoint an independent IRH: Never use your distributor as your IRH. The financial and operational risks of tying your registration to a commercial partner are significant.

3. Prepare for three-language labeling: If your device is intended for home use, budget for Hebrew, Arabic, and English translations of all labeling and IFU materials.

4. Plan for Sick Fund listing early: Regulatory approval is only half the battle. Start engaging with Sick Funds before or during the registration process to ensure commercial readiness.

5. Check SII requirements early: If your device is electro-medical, determine SII certification requirements upfront. The SII process can add time and cost if not planned for.

6. Monitor reference country validity: Your Israeli registration cannot exceed the validity of your reference country approval. Track your FDA/CE certificate expiry dates carefully.

7. Leverage the Declaration Route: If you have Class I devices, the Declaration Route provides immediate registration at zero government cost. Use it.

Frequently Asked Questions

Does Israel have its own device classification system? No. AMAR defers to the classification of a recognized reference country, with US FDA classification typically given priority.

Can I register a device without FDA or CE approval? Technically possible through the Standard Route, but AMAR strongly prefers prior approval from a recognized country. The process is significantly longer and more burdensome without it.

What is the Israel Registration Holder (IRH)? The IRH is a mandatory local representative who submits your registration application, holds your license, and manages post-market obligations. The IRH must be an Israeli citizen or corporation with ISO 9001 certification.

How long does AMAR registration take? Class I: Immediate (Declaration Route). Class II Fast-Track: 45–60 business days. Class III Standard: 120 calendar days (often 4–6 months in practice).

What languages are required for labeling? Professional-use devices: English only. Home-use/layperson devices: Hebrew, Arabic, and English.

Do I need SII certification? Certain electro-medical devices require validation from the Standards Institution of Israel. SII accepts CB certificates and EMC reports from accredited testing facilities.

What is the cost of registering a medical device in Israel? Government fees are relatively low (NIS 0–1,200 depending on the route). Total costs including IRH and consultant fees range from approximately $3,000 for Class I to $25,000+ for Class III.

Do I need to be listed with the Sick Funds? From a regulatory perspective, no. From a commercial perspective, yes — practically all hospitals and clinics in Israel order through the Sick Funds, so formulary listing is essential for market success.

Related: For Middle East registration, see our Middle East SFDA & UAE Registration Guide. For Singapore registration, see our Singapore HSA Medical Device Registration Guide. For registration costs across all markets, see our Medical Device Registration Cost by Country Guide.