Medical Device Regulation In Israel: How Registration Works

If you want to sell a medical device in Israel, you need to register it with the Medical Equipment Division (known by its Hebrew acronym, AMAR) at the Israeli Ministry of Health before it is imported or marketed. For most foreign manufacturers the process leans heavily on an approval the device already holds in a recognized reference country, and since 2024 there are faster tracks for lower-risk devices. The details still trip people up: who files, which documents, what happens at customs, and what you owe after registration.

This guide walks through it in plain terms. We are an Israeli law firm that works with international clients, so we focus on how the rules operate in Israel and where the legal decisions sit.

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TL;DR

AMAR, the Ministry of Health’s Medical Equipment Division, registers medical devices, issues import permits and oversees marketing in Israel.
Registration usually builds on prior approval in a recognized country (Australia, Canada, Europe or the United States), and a foreign manufacturer must appoint a local representative in Israel.
Since the 2024 reform, Class I devices can use self-declaration and many Class II devices can use a 60-day expedited route. Class III stays on the standard route.
The standard route is officially listed at 120 days, and a device without valid registration and an import order will not clear Israeli customs.
The legal layer (representative agreement, distribution contract, IP, company structure) is worth settling before you file, not after.

Who regulates medical devices in Israel

The Ministry of Health regulates medical devices through AMAR. According to the Ministry’s own page, AMAR handles registration, issues different import permits, follows the marketing of devices and issues export documentation. In practice that means it supervises manufacturing, importing and marketing through registration, oversight and control. The unit was created in 1993 under the name Medical Equipment Unit, according to the Hebrew version of the same page.

A practical point for anyone running a clinical study: the Ministry lists a separate ottaa yhteyttä for inquiries about clinical trials of medical devices only, by email at Clinical.trials.devices@moh.health.gov.il, as stated on that AMAR about page. Registration questions and trial questions go through different doors.

What counts as a medical device

The definition is wider than many first-time exporters expect. Under the Medical Equipment Law, as described on AMAR’s licensing page, medical equipment includes:

an instrument used for medical treatment;
any instrument or computer software required to operate it, including accessories;
chemical, biological or biotechnological substances used with it;
ottaa yhteyttä lenses;
electrical equipment that emits ionizing or non-ionizing radiation for cosmetic treatment.

So software that drives a device, accessories and certain aesthetic equipment can all fall inside the regime. If your product sits near the line, settle the classification question first. It decides everything that follows.

The legal framework in short

The main legislation is the Medical Device Law, 5772-2012, together with the Medical Device Regulations (Registration and Renewal of Medical Device in the Register), 5773-2013, as laid out in the Legal 500 life sciences chapter for Israel.

There is a wrinkle worth knowing. That same guide notes that the Law has yet to formally enter into force, although the relevant players are acting in line with it. For a manufacturer, the takeaway is simple: do not treat the status as a reason to wait. AMAR procedures, registration requirements and import controls operate in practice today, and your registration holder will expect you to comply.

The registration routes since the 2024 reform

In 2024 Israel changed how low- and moderate-risk devices are registered. The U.S. International Trade Administration’s summary of the import reform describes the structure:

Device class	Route	Condition
Class I	Self-declaration	Low-risk device
Class II (low to medium risk)	Self-declaration or 60-day expedited registration	Registered and marketed in a recognized country
Class III	Unchanged standard route	Full registration review

The same source says the reform is expected to cut regulatory expenses by up to 20%, saving the market roughly 90 million ILS a year.

The Ministry of Health’s own procedure for fast registration says that devices of risk level II, and medium-risk IVDs, that meet the procedure’s conditions and rely on a declaration by the registration holder can use the fast route. That option is limited to devices registered and marketed in recognized countries, per the published MOH procedure.

How classification works

You do not choose a class from scratch. The class you start with usually comes from the reference market whose approval you rely on. A device classed as moderate risk there is generally treated as moderate risk for the Israeli track. This is why getting your reference-market file in order matters more than anything you do locally.

Reference-market approval: the backbone of most filings

For most foreign manufacturers, registration in Israel is based on prior approval in a recognized country: Australia, Canada, Europe or the United States. Per the Legal 500 guide, a device that is registered or approved for marketing in a recognized country can be registered in Israel on the strength of that approval.

That is the good news. Because the Israeli file leans on an existing approval, the work is mostly assembling, translating where needed, and presenting it correctly, not repeating clinical testing.

The documents AMAR looks for generally include:

the regulatory approval from the reference market (for example, a clearance letter or CE certificate);
a certificate confirming the device is freely sold in its country of origin;
a quality-system certificate for the manufacturer, such as ISO 13485 or another recognized standard;
importer documents, catalogs, instructions for use and labels.

Exactly which of these your device needs depends on its class and route, so confirm against the current AMAR procedure before you file.

Israeli-made devices without a reference approval

Devices made in Israel that do not have approval elsewhere follow a heavier path. According to the Legal 500 guide, the applicant must attach a risk analysis, a clinical evaluation, a clinical trial dossier and two professional medical opinions. If you are an Israeli startup or a foreign company building a device here, this is where regulatory planning, IP strategy and your corporate structure all intersect.

Timelines: what to expect

AMAR’s official Q&A page gives the benchmarks. The standard route is 120 days, while the fast-track route takes 10 to 60 working days, depending on the application type and the risk level of the device. Devices registered and marketed in a recognized country, including those made by Israeli manufacturers, may use the fast track if they meet its conditions. Otherwise they use the standard route.

Two planning tips from the way these timelines work in real launches:

Start the Israeli file early. The clock only starts on a complete submission, so a missing certificate costs you more time than any review stage.
Build in time for import steps. Registration is only one gate. You also need the import order and, for the goods themselves, customs clearance.

For current fees, check AMAR’s published fee schedule rather than relying on a third-party figure, since these are updated from time to time.

The Israeli registration holder

A foreign manufacturer cannot file alone. You need a local party in Israel, often called the registration holder (the Hebrew term is closer to “registration owner”), who is the ottaa yhteyttä point with AMAR and who files, renews and maintains the registration. This is the single most important commercial and legal decision in the process.

What you should think through before you appoint one:

Who owns the registration? The holder’s name sits on the register. If the relationship ends, you need a clear contractual path to move the registration to a new party.
Distributor or independent? Using your distributor as the holder is legally possible, but it ties your market access to a commercial partner. If you later change distributors, you may have to re-register or negotiate a transfer. A separately engaged holder avoids that tie.
Post-market duties. The holder is the one who files incident reports and handles recalls in Israel, so your agreement should say how fast you will give them information.
Quality credentials. Check what quality-system certifications and approvals the holder must have with the Ministry before you sign.

This is a contract question as much as a regulatory one. A short, well-drafted agreement that covers ownership of the registration, transfer on termination, information flows, costs and liability will save you from a painful dispute later. Our article on distribution agreements and import rules for foreign firms in Israel goes through the clauses that matter most.

Import: why registration comes first

In Israel, registration is not a formality you can do after shipping. Customs will not release a device that lacks the right approvals and import order. If you ship first and register later, you risk storage costs and returning the goods. Treat registration as the first step of your logistics plan.

If you are exporting from the US, our guide to what exporters to Israel must do under the trade agreement covers the customs and origin side. For a company planning an operating presence, we also cover tax residency and VAT traps when entering the Israeli market and, specifically, VAT registration for a foreign company.

After registration: renewals, changes and incident reporting

Registration is not a one-time event. Three things continue.

Renewals

According to AMAR’s Q&A page, a renewal application must be submitted during the four months before the registration expires. If your CE certificate is not yet current when you file a renewal based on a recognized country, you can explain this in a covering letter and commit to supplying it by a specified date. AMAR will then issue a temporary registration valid for six months after the previous registration expires. Put the four-month window in your calendar and give your registration holder a lead time of a few weeks on top.

Changes to the registration

The official procedure on changing registration (REG-2024/08, effective 1 January 2025) sets out when you must file. For devices registered on the basis of recognized-country approvals, a change application is needed only when:

the regulatory approvals (for example CE, a clearance, or a declaration of conformity) are updated;
the manufacturer’s quality-system approval, such as ISO 13485, changes;
an administrative change is made to the registration or certificate details.

The application includes a completed form, a short letter describing the nature and reason for the change, supporting documents where the change affects the original registration, and a manufacturer’s explanatory letter if the change stems from an adverse event or a field safety corrective action. The full text is in the gov.il procedure document.

Audits and incident reporting

Under Section 11 of the Medical Device Law, as summarized in the Legal 500 guide, the registration holder should audit and evaluate registered devices to improve safety and quality, and report on that to the Ministry. The holder should also report specified incidents, including:

severe malfunctions that pose a health risk;
use of a device that caused, or is suspected of having caused, harm;
unexpected adverse effects, significant injuries or death;
actions by international health authorities;
manufacturer notifications;
new safety findings in the scientific literature.

This puts a real obligation on your relationship with the holder. They can only report what they know, so your contract should require you to pass on global safety information promptly.

A practical sequence for a foreign manufacturer

Here is how we would lay out the work, in order:

Confirm that your product is a medical device under the Israeli definition, including software and accessories.
Identify your reference-market approval and check it is current, with the certificates AMAR will want.
Choose the route (self-declaration, expedited, or standard) based on class and market history.
Select and contract your Israeli registration holder, with ownership, transfer and reporting terms in writing.
Prepare the file and submit through the holder.
Plan the import: import order, customs, VAT and your distribution contract.
Diarize renewal four months before expiry, and agree a process for change notifications.

Mistakes we see most often

Shipping before registration is final. Goods held at customs cost money every day.
Letting the distributor hold the registration with no exit terms. It works until the relationship sours.
Outdated certificates. A lapsed certificate in the reference market can stall both renewals and changes.
Ignoring IP. Before you disclose technical files to partners, your patent, trademark and trade-secret position in Israel should be in order. See our piece on locking in IP and manufacturing for biotech R&D in Israel.
Forgetting data. Connected devices and patient data bring Israeli privacy law into play. Our Israel data privacy law compliance guide is a good starting point.

Perspective

Most foreign medical device companies come to us after the regulatory plan is already moving. The registration itself is usually manageable. What causes trouble is everything wrapped around it: a distributor who holds the registration with no way out, an import schedule that assumes approval will arrive sooner than it does, or IP that was shared before it was protected in Israel.
Our view is simple. Treat Israel as a legal project and a regulatory project at the same time. Decide who holds the registration, put ownership and transfer rights in writing, protect your IP, and choose the right corporate structure for the way you plan to sell. These decisions are cheaper to make at the start than to unwind later.
We work with international clients, including startups, biotech companies and foreign brands, and we do it remotely. You do not need to fly to Israel to get this done. We communicate quickly, in English, and we build the legal strategy around your commercial goals.
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How Menora Law can help

We are an Israeli law firm serving international clients, and our work around medical devices sits on the legal side of the launch: structuring your Israeli presence, contracting with distributors and partners, protecting your inventions and brand, and handling the corporate and tax questions that follow. Our offering includes corporate structuring and company formation, trademark and patent filing, and representation of international companies in Israel, and we have specific biotech industry experience.

If you are planning to bring a device to Israel, contact Menora Law before you appoint a registration holder or sign a distribution agreement. We can review the terms, advise on structure, and work with you remotely from day one.

FAQ

Do I need to register a medical device in Israel if it is already approved elsewhere?

Yes. Approval in a recognized country, such as Australia, Canada, Europe or the United States, does not replace Israeli registration. It does, however, form the basis of most Israeli applications, which makes the process faster than starting from zero. Your Israeli registration holder files with AMAR.

How long does medical device registration in Israel take?

AMAR’s official Q&A lists 120 days for the standard route and 10 to 60 working days for the fast-track route, depending on the application type and the device’s risk level. The right track depends on your device’s class and whether it is registered and marketed in a recognized country. Allow extra time for assembling certificates and for import steps.

Can a foreign manufacturer register a device without a local representative?

No. A foreign manufacturer needs an in-country registration holder to deal with AMAR and manage the application. Choose carefully and put ownership, transfer and reporting terms in a written agreement, because the holder is also responsible for post-market duties in Israel.

What happens if I import a device before it is registered?

A device without valid AMAR registration and an import order will not clear customs. That can mean storage charges and having the goods sent back. Finish registration, or confirm the applicable import permit, before you ship.

Is the Medical Device Law in force?

According to the Legal 500 guide, the Law has yet to formally enter into force, though relevant parties are conducting themselves in accordance with it. AMAR registration and its procedures operate in practice, so plan on full compliance.

Medical Device Regulation in Israel: How Registration Works

TL;DR

Who regulates medical devices in Israel

What counts as a medical device

The legal framework in short