Israel MOH Device Register: 28,800 Devices, 92% Imports, and Importer Concentration

Executive Summary

Israel's medical device market is one of the Middle East's largest, and it is built almost entirely on imported technology. Our analysis of the complete public register maintained by the Ministry of Health's Medical Device Division (AMAR) finds 28,821 registered medical devices as of March 2026, supplied by manufacturers in 78 countries and channeled through 2,111 registered owners — the Israeli importers and registration holders that serve as the mandatory regulatory interface between foreign manufacturers and AMAR.

Three structural findings define the market:

1. Israel is 91.8% import-dependent. Only 8.2% of registered devices are manufactured in Israel itself. The remaining 26,468 devices are produced abroad and enter through the registered-owner mechanism.
2. Three countries supply the majority of devices. The United States (28.0%), Germany (13.4%), and China (12.3%) together account for 53.6% of every registered device. The top 10 countries of origin cover 81.7%.
3. The licence layer is fragmented but gatekept. The top 10 registered owners (importers) hold 18.1% of registrations; the top 50 hold 46.1%. With an Herfindahl-Hirschman Index (HHI) of 63, the importer layer is competitively fragmented — but every foreign device must still pass through one of these local entities, which AMAR calls the Israel Registration Holder (IRH).

This article breaks down the Israeli device register by country of manufacture, registered-owner concentration, intended use setting, and registration-permission type — giving regulatory strategists and market-access teams a quantitative foundation for Israel planning.

Data Source and Methodology

All statistics in this article are derived from our direct analysis of the Israel Ministry of Health (AMAR) public medical device register (public extract dated 10 March 2026). The dataset contains 28,821 device registration records with Hebrew and English product names, registration number, manufacturer name, country of manufacture (countryCreated), registered owner (registeredOwner — the importer/IRH of record), intended use location (usagePlace), and registration permission type (typePermission).

Country-of-origin, registered-owner, and use-setting counts were aggregated directly from the register fields. Registered-owner concentration was computed using standard Herfindahl-Hirschman Index (HHI) methodology, where each owner's share (as a percentage) is squared and summed across all 2,111 owners. Percentages are calculated against the total record count (28,821) unless otherwise noted. Registered-owner names appear in Hebrew in the source; this article provides English transliterations.

Israel's Regulatory Framework: A Reference-Recognition Market

Israel's medical device market was valued at approximately $2.4 billion in 2022, with a compound annual growth rate of about 2% projected through 2028, and medical devices account for roughly half of the total healthcare industry market share. Israel's life-sciences sector is innovation-heavy — domestic developers and foreign exporters both rely on the same import infrastructure.

A defining feature of Israeli regulation is that AMAR does not maintain its own device classification system. Instead, it defers to the classification of a recognized reference country. Israel relies on approvals from a defined list of recognized countries — chiefly the United States (FDA), Europe (CE Marking under MDR/IVDR), Canada, and Australia, with the United Kingdom, New Zealand, Switzerland, and several others also on the recognized list; the US FDA classification is typically given priority. Japan-approved devices are not formally recognized by law but are frequently accepted in practice. This reliance on foreign approvals is why Israel's register is, in effect, a map of which global devices have been carried into the country by a local importer.

Because foreign manufacturers cannot apply directly, every device must be registered through an Israel Registration Holder (IRH) — an Israeli citizen or corporation that holds ISO 9001 certification and acts as the official liaison with AMAR. The IRH submits applications, manages renewals and modifications, and bears post-market obligations including adverse-event reporting. Registration routes follow the risk tiers of the reference country: a Declaration route for the lowest-risk devices (self-declaration), a Fast-Track route granting 60-day expedited registration for devices already registered and marketed in a recognized country, and a Standard route for higher-risk devices. Validity runs up to five years for standard devices (and cannot exceed the reference country's approval validity), three years for implants, and per-class for IVDR devices. The target AMAR review timeline for the Standard route is 120 calendar days, though actual timelines commonly run four to six months depending on submission quality and device complexity; updated procedural guidance for submission content and format (REG-2024/03) took effect in January 2025.

Demand in the Israeli market is concentrated in several high-volume clinical categories. AMAR and trade sources identify cardiovascular devices, hospital supplies, orthopaedics, neurology, general surgery, and minimally invasive surgical instruments as the prominent device segments, and Israel records among the highest per-capita rates of ophthalmic and fertility procedures in the region — together with a substantial dental segment — which is reflected in the breadth of hospital and clinic devices in the register.

In short, the registeredOwner field in the register is not an administrative detail — it is the IRH, the single most important local relationship for any foreign manufacturer's market access in Israel.

Country of Manufacture: Where Israel's Devices Come From

The most striking finding is the overwhelming foreign origin of registered devices. Devices are manufactured in 78 countries, but the distribution is concentrated among a small number of large medtech-producing nations:

Several patterns stand out:

• The United States dominates by a wide margin. US-manufactured devices account for 28.0% of the register — more than double Germany, the second-largest source. This is consistent with AMAR's prioritization of FDA classification and the heavy US-medtech presence in the Israeli market.
• China is the third-largest source, ahead of Israel itself. At 12.3% of registrations, China-made devices now exceed the domestic Israeli share (8.2%), reflecting the global shift of medtech manufacturing to China for mid- and low-risk consumables, disposables, and imaging accessories.
• Israel's domestic manufacturing share is modest. Just 2,353 devices (8.2%) are manufactured in Israel. While Israel is renowned for device innovation and start-ups, the commercial register is dominated by imported products — domestic innovation frequently exits to US or EU approval first, then re-enters through the reference-recognition route.
• European manufacturing is collectively large. Germany, Italy, the UK, France, Switzerland, Sweden, and other European nations together account for roughly 36% of the register, making Europe as a bloc the second-largest source region after the US.

The foreign-manufactured share is 91.8% (26,468 of 28,821 devices). For market-access teams, this confirms that Israel planning is fundamentally an import-and-registration exercise rather than a domestic-manufacturing market.

The Registered-Owner Layer: Who Holds Israel's Device Licences

Under Israel's framework, the registered owner of record is the IRH — the local importer or registration holder that maintains each device's licence and the regulatory relationship with AMAR. Among 28,821 registered devices, there are 2,111 distinct registered owners, but the distribution is skewed toward a layer of established Israeli medical importers:

Concentration metrics:

• Top 5 registered owners: 2,918 devices (10.1%)
• Top 10 registered owners: 5,213 devices (18.1%)
• Top 20 registered owners: 8,416 devices (29.2%)
• Top 50 registered owners: 13,288 devices (46.1%)
• HHI: 63 (moderate, fragmented)

The HHI of 63 places Israel's importer layer well below the threshold for high concentration (HHI > 2,500) and indicates a competitively fragmented licence landscape. There is no single dominant gatekeeper — even the largest holder (Medtechnika) controls only 2.6% of registrations. However, the practical reality is more nuanced than the HHI suggests: the top 50 owners collectively hold nearly half of all devices, and these are established medical importers with the ISO 9001 certification, AMAR relationships, and post-market infrastructure required to act as IRH. New entrants face a long tail of more than 2,000 smaller holders, but the high-volume commercial business flows through the established names.

A notable feature is the presence of Medtronic Trading Ltd. (512 devices) among the top owners — a global major operating its own Israeli entity as IRH. The other top holders are independent Israeli importers and distributors that aggregate portfolios from many foreign manufacturers, which is the more common model for mid-size foreign brands entering Israel.

Implications for market entry. Foreign manufacturers entering Israel typically choose between (1) appointing an established importer/distributor that also serves as IRH, (2) using a specialized regulatory representative as IRH while retaining distribution control, or (3) for the largest firms, establishing a direct Israeli entity. Because the IRH controls the registration and renewal cycle, and because AMAR processes renewals and modifications through the holder of record, this is a long-term commercial relationship rather than a one-time transaction.

Where Devices Are Used

The register records an intended use setting (usagePlace) for each device, offering a view of where Israel's medical technology is deployed:

Nearly half of all registered devices are intended for hospital use, consistent with Israel's advanced hospital infrastructure and the concentration of high-acuity and surgical technology in the hospital channel. Laboratory devices account for 10.4%, reflecting a sizable in-vitro diagnostics segment (Israel's IVD market was projected to reach approximately $474.7 million). Home-use devices remain a small share at 3.7%, a segment likely to grow as digital-health and remote-monitoring products expand.

Registration Permission Type

The register's typePermission field identifies how a subset of devices were registered. The largest single recorded category is registration by declaration (נרשם בהצהרה), reflecting devices that entered via the self-declaration route used for the lowest-risk reference-country devices. The majority of records do not carry an explicit permission-type label in the public extract, so this field undercounts the true declaration-route volume; we therefore report country-of-origin and registered-owner breakdowns as the primary structural measures rather than permission type.

Israel's Import Reform and What It Means for Volume

Israel's registration framework is actively evolving. Beginning in August 2023, the Ministry of Health rolled out an import reform (its "enabling regulation") that introduced new registration tracks for FDA- or EU-approved devices and equipment, organized around risk tiers. Low-risk (Class I) devices moved to a declaration (self-declaration) route (mandatory for Class I from 1 January 2024); low-to-medium-risk (Class II) devices became eligible for a fast-track expedited review — as short as 14 days for devices holding two recognized-country authorizations, or 60 days with a single FDA 510(k) — when already registered and marketed in a recognized country; and high-risk (Class III) registration was left largely unchanged. AMAR estimated the reform would reduce regulatory expenses in the import process by up to 20%, saving the market roughly 90 million ILS (about $24 million) per year.

For market-access teams, the practical effect of the reform is that devices already approved by the FDA or a CE Notified Body face the fastest, lowest-cost entry path, while devices lacking a recognized reference-country approval encounter longer timelines and heavier documentation. This reinforces the country-of-origin pattern visible in the register: the prevalence of US- and German-manufactured devices is partly a regulatory-architecture outcome, not just a commercial one.

Israel in Regional Context

Israel is the largest device market among the Gulf and Levant economies that fall outside the Gulf Cooperation Council (GCC) harmonization framework. Its reference-recognition model and IRH mechanism make it one of the faster Middle East markets to access for manufacturers that already hold US or EU approval — substantially quicker and lower-cost than markets requiring full standalone review. By contrast, the GCC markets (Saudi Arabia's SFDA, the UAE's EDE, Bahrain's NHRA, and Qatar's health ministry) operate distinct authorization-holder and local-representative regimes with their own concentration dynamics.

For manufacturers pursuing a Middle East strategy, the Israeli register's structure — fragmented importers, US/EU-dominant supply, and a declaration/fast-track path for reference-approved devices — makes it a natural early market entry after US or EU clearance.

Key Takeaways

• 28,821 registered devices supplied by manufacturers in 78 countries and held by 2,111 registered owners (IRHs)
• 91.8% of devices are imported; only 8.2% are manufactured in Israel
• The US (28.0%), Germany (13.4%), and China (12.3%) supply 53.6% of all registered devices; the top 10 countries cover 81.7%
• The importer layer is fragmented (HHI 63) but the top 50 owners hold 46.1% of licences, led by Medtechnika, A.M.I. Technologies, and J-C Healthcare
• 49.7% of devices are hospital-use, with IVD/laboratory devices accounting for a further 10.4%
• Israel's import reform (rolled out from August 2023) expanded the declaration route and fast-track review for FDA/EU-approved devices, targeting ~20% lower regulatory cost

Data Source

Analysis sample: Israel Ministry of Health (AMAR) public medical device register, public extract dated 10 March 2026, 28,821 device records. Country-of-manufacture, registered-owner, and use-setting aggregates computed directly from register fields. Registered-owner concentration computed via HHI across all 2,111 owners. Registered-owner names transliterated from Hebrew. Regulatory framework, market size, and reform details sourced from AMAR, the Israel Ministry of Health, Emergo by UL, MedEnvoy, Pure Global, and the US International Trade Administration. All numbers reflect the public register and may differ slightly from AMAR's internal records due to the timing of data publication.