AMAR Registration in Israel: The Blind Spots Medical Device Importers Miss

The Importer's Mental Model — and Why It Doesn't Work in Israel

An importer arriving with an FDA-cleared or MDR-marked device typically makes a logical assumption: "We've done the hard work. Israel is a small market — registration is a formality." That assumption adds one to two years to the timeline. We have seen it often enough to anticipate every beat of the first meeting.

The Israeli Ministry of Health is not difficult or obstructionist. It is an independent regulator with its own internal logic — logic that derives from a single-payer public healthcare system, not from the multi-payer environments that shaped FDA and CE thinking. The frameworks are not interchangeable, and the gaps are not obvious until you are inside them.

What works at FDA does not always transfer. What works under CE does not always transfer. And a consultant who has only operated in one of those systems may not know what they are missing.

AMAR: What It Actually Is

AMAR — "Isshur Michshor Refu'i," or Medical Device Authorization — is Israel's registry of authorized medical devices. To sell a medical device in Israel, it must be registered in this registry, and the registration holder must be an Israeli entity — not the foreign manufacturer directly. That basic structure generates several requirements that catch importers off guard.

If you are an Israeli manufacturer selling your own product directly, your path differs. If you are an importer bringing in a foreign product, you need to serve as the RPI — the Responsible Person in Israel. And if you are a distributor receiving product from another importer, you need to verify that the existing registration covers your distribution arrangement. These are not equivalent situations.

Why the "Hashlamot" Process Is Not a Failure — It's Structural

"Hashlamot" — the Hebrew term for supplementary document requests — is the official name for the regulator's clarification rounds. It is not a pejorative term from the regulator's perspective; it is part of the process. The problem is that inexperienced submitters interpret the first Hashlamot round as "nearly done," not recognizing that second and third rounds are ordinary outcomes without proper preparation.

We have seen cases where an independent submitter went through four Hashlamot rounds on a file that should have passed in one. Each round added three to six months. The total process took 28 months instead of eight to ten — not because the regulator was unreasonable, but because the initial submission did not address what the regulator needed to see, in the format the regulator expected to find it.

Common Hashlamot triggers include:

Source documents not translated, or only partially translated, into Hebrew
Manufacturer declarations that do not reference the exact product version being submitted
Clinical references that do not cover the specific indication as labeled
RPI details that are missing or inconsistent with the commercial registration
Classification questions left open because the submission was prepared without examining Israeli category definitions independently

The RPI: More Than a Signature Requirement

One of the requirements that surprises importers on first encounter is the appointment of the RPI — the Responsible Person in Israel. This is an Israeli entity that assumes legal and operational responsibility for the device in the Israeli market.

This is not a clerical matter. The RPI must demonstrate proven competence — and in certain cases, the regulator expects that competence to be substantiated, not merely declared. The power of attorney between the foreign manufacturer and the RPI must cover specific authorities, including the ability to execute a market recall. The RPI's details must appear on the product label.

Changing the RPI after registration is possible, but requires a registration update — a process that takes time and restarts part of the regulatory clock. Companies that choose an RPI without long-term planning find themselves constrained when that party exits the picture.

Power of Attorney: Substance Over Form

The power of attorney between the manufacturer and the Israeli entity is a document the Ministry of Health examines carefully. Having a power of attorney is not enough — it needs to cover specific authorities the regulator expects to see. Importers who arrive with a generic, globally-templated power of attorney typically receive a Hashlamot request on this point alone.

The document needs to explicitly include: authority to receive instructions from Israeli regulators, authority to represent the manufacturer before the regulatory authority, and authority to execute market safety actions including product recall. Each of these that is missing becomes a potential question.

Classification Gaps: Where Israel Diverges from the EU and FDA

Israeli device classification is primarily based on the GHTF framework (now IMDRF) with adaptations for specific categories. The problem arises when importers assume that a Class IIa classification under the MDR translates directly to an equivalent category in Israel — which is not always the case.

Common divergences we have encountered:

Devices classified as Class I in Europe (requiring no Notified Body) that fall into Class IIa in Israel — with all the implications for submission depth and required clinical evidence
Software as a Medical Device (SaMD) where FDA and Israeli classification differ because the classification methodologies use different risk criteria
In-vitro diagnostic devices that enter a completely different regulatory category in Israel compared to the IVDR classification applied in Europe

Incorrect classification reveals itself in the first Hashlamot round — but correcting it often requires rebuilding a significant portion of the submission, not just updating a checkbox.

Israel's Single-Payer Dynamics: Why They Affect Your AMAR Timeline

Israel operates a national health system with four competing health funds (kupot holim). This structure influences the AMAR process in ways that are not always visible to importers approaching from a multi-payer market background.

First, AMAR registration is a mandatory precondition for participating in procurement tenders at health funds and government hospitals. Without registration, there is no tender. This means the registration timeline directly gates revenue cycles — and a six-month slip in registration can mean missing an annual procurement round entirely.

Second, Israeli public hospitals typically operate with internal procurement committees and approval processes that add six to twelve months on top of the regulatory registration. Companies that plan for "registration then sales" are not accounting for this institutional layer.

Third, the Ministry of Health's procurement administration maintains approved device lists at the category level. Getting into the right list — not merely receiving a registration number — matters for actual market access. These are different steps that require different actions.

Pre-Submission Self-Check: Questions to Ask Before Filing

Has Israeli classification been verified independently — not assumed to match FDA or CE classification?
Has the RPI been identified, agreed, and demonstrated competence — not merely declared it?
Does the power of attorney explicitly cover all three authorities — regulatory instructions, representation, and recall?
Have source documents been fully translated into Hebrew — not partially, not by machine without review?
Does the manufacturer's declaration reference the exact product version being submitted — catalog number, software version if applicable?
Do clinical references cover the specific labeled indication — not a similar indication, not a broader category?
Is the submission timeline built with at least one Hashlamot round as a realistic scenario — not the optimistic path?
Is the registration timeline synchronized with the intended customer's procurement cycle — health fund, hospital, tender date?

Rescue Cases: What We Do When a Process Has Stalled

A meaningful portion of our AMAR work is entering processes that have stopped moving. The pattern recurs: an importer engaged a consultant who promised six to eight months to registration; eighteen months later they are in a second Hashlamot round with no clear path forward, and a customer waiting on the other side.

The approach when entering a stalled process is not to start over — that is almost never the right answer. It is to analyze the full regulatory correspondence, identify the root cause of the Hashlamot questions, reconstruct the specific sections of the submission that are failing, and build responses that close the open points in a way that will hold up to further scrutiny without generating new questions.

The average time saved in AMAR rescue cases we have handled: eight to fourteen months. Not because we move faster than the regulator, but because we write submissions the regulator does not need to ask questions about.

The Bottom Line

AMAR is not "another FDA in Hebrew." It is an independent regulator with internal logic derived from the specific reality of the Israeli healthcare market. The right approach is to arrive with the baseline assumption that this process requires understanding the system on its own terms — not with the assumption that the credibility of foreign approvals speaks for itself.

We are not a large consulting firm, and that is relevant here: we do not hand off AMAR submissions to junior staff while a senior consultant manages the relationship. The people who know your file are the people who answer the Hashlamot. If you are approaching an AMAR submission — the checklist above is a useful starting point. If you are mid-process and stuck — it is worth a conversation.