Israel’s Ministry of Health Medical Equipment Division doesn’t run an independent approval system for medical devices and that’s the first thing worth knowing about Israel Medical Device Regulations. Instead, it simply builds on approvals the device already holds in recognized reference countries like the US, EU, Canada or Australia.
That reliance on foreign approvals makes Israel Medical Device Registration faster than other markets. But it also means the Israel Medical Device Registration Process is only as smooth as your existing regulatory file. Whatever inconsistencies present in the existing FDA or CE file just get carried straight into the Israeli submission, potentially delaying the review process.
This article covers classification, registration routes, local representative requirements, documentation, labeling, timelines, and post-market duties, the details that matter before the submission reaches Israel.
Regulatory Authorities for Medical Devices in Israel
AMAR and SII are the two bodies that matter for medical device regulation in Israel. AMAR is the registration authority. SII is the testing body for electro-medical equipment.
AMAR (Medical Equipment Division): This is the primary authority. According to the Ministry of Health, AMAR manages medical equipment registration, issues import permits, oversees marketing of medical devices and handles export documentation.
Standards Institution of Israel (SII): SII tests medical devices. For electro-medical equipment, SII’s Electric and Electronics Laboratory evaluates compliance with the SI 60601 series covering electrical safety and electromagnetic compatibility. If the medical device has a power cord or a battery driving any real load, manufacturers must plan for SII involvement alongside AMAR.
Israel Medical Device Classification
AMAR adopts whatever risk class your device already carries in its reference country of approval. There’s no separate Israel Medical Device Classification.
| Reference Classification | Risk Level |
| FDA Class I / EU MDR Class I | Low |
| FDA Class II / EU MDR Class IIa | Low–Moderate |
| EU MDR Class IIb | Moderate |
| FDA Class III / EU MDR Class III | High |
IVDs follow the same borrowed-classification logic. EU IVDR Class A falls at the low-risk end, Class B in the low-to-moderate range, Class C at moderate risk and Class D at the highest risk.
Authorized Representative (AR) Requirements in Israel
Registering as a foreign manufacturer isn’t possible without a local entity behind you. The Israel Registration Holder (IRH) fulfills this role, acting as the manufacturer’s local regulatory representative throughout the registration process.
The IRH must be based in Israel and should either be an Israeli citizen or a locally established corporation. The IRH is also generally expected to hold ISO 9001 or equivalent QMS certification. Once appointed, the IRH becomes AMAR’s point of contact, holds the registration, submits renewals and modifications and also manages post-market obligations including adverse event reporting.
Manufacturers should ensure contractual responsibilities between the manufacturer and Authorized Representative are clearly documented.
Medical Device Regulatory Guidelines in Israel
Medical Device Regulatory Requirements in Israel come from two layers, and it’s simpler than it sounds:
- The Medical Equipment Law (2012) and its Regulations for Medical Equipment Registration set the legal foundation.
- AMAR’s guidance documents: The practical, day-to-day rules manufacturers actually work from. It covers how to file under each route, what triggers a Fast-Track versus Normal review, how renewals work and what counts as a reportable modification to an existing registration.
These documents get revised periodically, so always confirm you’re working from the version currently posted on the Ministry of Health website.
Medical Device Registration Process in Israel
The Israel Medical Device Registration Process follows nine steps, from classification all the way through to market entry.
Step 1: Confirm device classification
Everything downstream depends on the classification of the device from the reference country approval. AMAR simply inherits the classification already assigned by the FDA, EU MDR, Health Canada or Australia’s TGA.
If the reference country classification is unclear or under appeal in that market,then the manufacturer must resolve it there first, because carrying an unresolved classification question into an AMAR submission just moves the same problem to a second regulator.
Step 2: Appoint your Israel Registration Holder (IRH)
Foreign manufacturers cannot hold their own AMAR registration. The IRH is the legal entity that holds it for them. IRH needs to be an Israeli citizen or a locally established corporation with valid ISO 9001 certification in place. Sorting this out early also gives the IRH time to review the reference country file for gaps before it becomes AMAR’s problem to flag.
Step 3: Determine the correct registration route
Manufacturers may apply through the Declaration, Fast-Track 1, Fast-Track 2 or Normal registration pathway, depending on the device classification and the strength of the reference country evidence. The route decides how much documentation manufacturers need, how long AMAR takes to respond and which forms apply for.
Getting this wrong is one of the more common ways manufacturers lose weeks.
Step 4: Build the dossier
This covers manufacturer and production site details, reference country approval certificates (FDA clearance, CE certificate, or Declaration of Conformity), QMS certifications for both the manufacturer and the IRH, and labeling and IFU content translated and formatted for the Israeli market.
For the Normal Route, where the device lacks prior reference country approval, add risk analysis, clinical evaluation and a clinical trial data summary. Every document needs to cross-reference the same manufacturer name, product name and model numbers.
Step 5: Submit through the IRH
AMAR does not accept submissions directly from foreign manufacturers. The IRH files the dossier on the manufacturer’s behalf and becomes the named contact for the application going forward.
Step 6: AMAR review
Review depth and duration depend entirely on the route selected. It can take anywhere from roughly 48 hours for a clean Declaration Route filing to several months for a full Normal Route review. AMAR may issue clarification requests mid-review, and how quickly the IRH responds to these directly affects the final timeline. A slow response to a documentation query can add weeks.
Step 7: Registration certificate issued.
Once AMAR is satisfied, the device is added to the medical equipment register and a registration certificate is issued to the IRH. From here, import permits tied to that registration can be pursued and the device is formally cleared to be marketed in Israel under the terms of that registration.
This certificate also carries a validity period, so it’s worth noting the expiry date the moment it arrives rather than waiting until renewal time shows up.
Step 8: Confirm SII testing where applicable
For electro-medical devices, SII testing under the SI 60601 series can run in parallel with AMAR’s review rather than after it and doing so in parallel is what actually saves time. Waiting until AMAR registration is granted before even booking SII testing is a common and entirely avoidable way to add months to a launch that didn’t need to take that long.
Step 9: Market entry
Importation and commercial sale can proceed once registration and SII certification are both in hand. This is also the point to confirm that import documentation, customs paperwork and distributor agreements are actually ready to move because registration alone doesn’t guarantee goods clear customs smoothly.
Most delays don’t happen in Step 6. They happen in Step 4. Incomplete or inconsistent documentation that triggers AMAR queries and slow response to it can significantly delay the timeline.
Required Documents for Medical Device Registration in Israel
AMAR organizes submissions into distinct document folders. The same documentation structure is generally followed for Declaration, Fast-Track and Normal Route submissions, although additional requirements may apply depending on the registration pathway.
| Document Folder | Contents |
| Submission Letters | Signed declaration or application form specific to the route (new/renewal/change) |
| Regulatory Authorizations | FDA 510(k)/clearance, CE certificate, Declaration of Conformity, or other recognized reference country approval |
| Importer/IRH Documents | QMS certificate (ISO 9001) of the Israel Registration Holder |
| Manufacturer Documents | QMS certificate (ISO 13485 or equivalent) of the legal manufacturer |
| Labeling | Instructions for Use (IFU), product labeling, and catalogs |
For devices without prior reference country approval that are filed under the Normal Route, AMAR additionally expects a risk analysis, a clinical evaluation and a summary of clinical trial data.
One more point worth noting is that the manufacturer name, product name and model numbers on the FDA or CE certificate need to match the labeling and dossier exactly. An outdated legal address or a model number typo is a small thing that causes a real rejection.
QMS Requirements for Medical Devices in Israel
There’s no separate Israel-specific QMS standard to build from scratch. If your quality system already supports FDA or EU MDR compliance, that groundwork transfers directly into the AMAR dossier.
The manufacturer is expected to hold ISO 13485 or a recognized GMP equivalent, demonstrating that its quality system meets international standards. The Israel Registration Holder (IRH), separately, is expected to hold ISO 9001, confirming that the local entity managing the registration itself operates under a controlled quality system.
AMAR’s registration procedures ask for these certificates to be included as part of the standard documentation folder.
Medical Device Labeling & IFU Requirements in Israel
Labeling for the Israeli market generally needs to appear in Hebrew, Arabic and English, based on AMAR’s published labeling guidance for marking medical accessories and devices. Devices intended strictly for professional or in-facility use may carry some flexibility on this, but that depends on the specific device and setting. It’s not something to assume without checking current guidance.
Labeling should cover device name, manufacturer details, intended purpose, batch/serial numbers, expiry, storage, and safety warnings. The IFU should give enough detail for safe installation, operation, maintenance, and disposal.
Because Israel recognizes reference country approvals, most existing IFU content carries over largely intact. Translation and formatting adjustments are still needed almost every time, and manufacturers consistently underbudget the time this takes.
Registration Timelines for Medical Devices in Israel
Timelines vary sharply by route, based on typical AMAR processing patterns observed in practice:
- Declaration Route: This route is the fastest. It takes 48 hours once a complete submission is in. Covers Class I devices and Class A IVDs backed by prior reference country approval.
- Fast-Track Route 1: It runs closer 45 business days. Applies to FDA Class II or EU Class IIa devices with at least 4 months of market history in the reference country.
- Fast-Track Route 2: It takes roughly 60 business days. Reserved for EU Class IIb devices holding approval in two reference countries, with at least 6 months of market history in one of them.
- Normal (Standard) Route: It is the longest route.120 calendar days officially, though closer to 4.5–6 months in practice. Applies to Class III devices, Class D IVDs or any device without prior reference country approval or Fast-Track eligibility.
Registration validity commonly runs several years, though it cannot exceed the validity of the underlying reference country approval. Class II, Class III and equivalent-risk IVD registrations must be renewed within four months before expiry as per AMAR’s renewal procedure. Class I devices follow a separate annual renewal cycle starting October 1, rather than the expiry-based window.
Medical Device Registration Costs in Israel
Government fees and overall registration costs depend on several factors:
- Registration route (Declaration, Fast-Track or Normal): It is the biggest driver of overall cost
- Device risk class: Higher classes require more extensive review and documentation
- IRH service fees: It varies by provider
- Translation costs: For labeling, IFU and dossier content
- SII testing fees: Only where applicable, for electro-medical devices
- Technical/clinical documentation work: Risk analysis and clinical evaluation, mainly relevant to the Normal Route
The Ministry of Health publishes applicable government fee information through its official administrative procedures. Fee schedules can change, so verify the latest applicable fees before submission.
Import Requirements for Medical Devices in Israel
Israel Medical Device Import Requirements are tied directly to registration status. An unregistered device cannot legally be imported for commercial sale, and Israeli customs will expect valid AMAR registration documentation at the point of entry. AMAR is the body issuing the associated import permits.
Import requirements generally include:
- Valid AMAR medical device registration
- Compliance with Ministry of Health import procedures
- Importer responsibilities, including maintaining registration and labeling documentation
- Standard customs clearance procedures
- Applicable tax and import regulations, with additional obligations that may apply through the Israel Tax Authority
Where SII certification applies for electro-medical devices, import clearance can depend on two separate approval trails: AMAR registration and SII testing. Both processes must be completed where applicable before the device can be marketed in Israel.
Post-Market Surveillance Requirements in Israel
Post-market surveillance in Israel runs primarily through the IRH, since AMAR wants an accountable, reachable party inside the country rather than relying on a manufacturer’s team overseas.
Adverse events and malfunctions get reported once the company becomes aware, generally covering anything that causes or risks death, life threat, or hospitalization. The IRH is also responsible for sharing relevant safety notices from regulatory authorities such as the U.S. FDA with the Israeli Ministry of Health.
Ongoing risk and traceability monitoring is shared between manufacturer and IRH, with AMAR able to request closer monitoring for higher-risk devices. Registration maintenance also includes timely renewal.
Conclusion
The Medical Device Approval Process in Israel rewards manufacturers who arrive with a clean reference country file and a correctly matched registration route. Classification isn’t something Israel invents on its own. It inherits whatever the FDA or EU already assigned.
So, the real work is picking the right AMAR route and keeping documentation internally consistent across every certificate and label.
Not sure whether your device qualifies for Fast-Track or needs the full Normal Route review? That’s exactly the kind of question worth raising before you start building the dossier. Learn more about our Israel regulatory affairs services or reach out to us at info@artixio.com.
FAQs
Q1. What is AMAR in Israel medical device registration?
AMAR is the Medical Equipment Division of the Israel Ministry of Health, responsible for registering medical devices, issuing import permits and overseeing device marketing in the country.
Q2. Does Israel have its own medical device classification system?
No. Israel Medical Device Classification adopts whatever risk class the device already carries from a recognized reference country like the US, EU, Canada or Australia.
Q3. Is a local representative mandatory for Medical Device Registration in Israel?
Yes. Foreign manufacturers must appoint an Israel Registration Holder (IRH) based in Israel to submit and manage the registration on their behalf.
Q4. How long does the Israel Medical Device Registration Process take?
It depends on the route. Roughly 48 hours for Declaration Route devices, about 45–60 business days for Fast-Track and 120 days or more for the Normal Route.
Q5. Are CE-marked devices accepted for AMAR Medical Device Registration?
Devices legally placed on the market in the EU under MDR or IVDR are generally recognized as reference country evidence, subject to AMAR’s current registration procedures.
Q6. What language should medical device labeling be in for Israel?
Based on AMAR’s labeling guidance, labeling generally needs to appear in Hebrew, Arabic, and English, with some flexibility possible for devices restricted to professional or in-facility use.
