AMAR · Middle East & AfricaEvery Israel dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Search official AMAR device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official AMAR regulations and guidance documents.
Review current AMAR application, review, and renewal fees.
Estimate the likely AMAR pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent AMAR policy, guidance, and compliance updates.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Israel requirements.
Describe a device and find comparable products in the AMAR registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Compare official AMAR handling times by registration track: declaration, fast-track channels and the regular route.
Describe your device and get a preliminary AMAR class by reference market (EU or FDA) with an explanation and source links.
24 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-09-07
AMAR registration fees in ILS · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| AMAR registration, change, or renewal | ILS 0 | Verified |
Ministry of Health - Medical Devices Division (MOH-MDD) review clocks and planning ranges · Reference-market classes: EU I, IIa, IIb, III; US FDA I, II, III (FDA prevails on conflict) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Declaration track — Class I (incl. Is/Im/Ir) and low-risk IVDs(Declaration based on prior registration in a recognized state) | 1-2 days | 1-2 days | Verified |
| Fast track 1 — Class II (FDA approval), EU Class IIa, IVD Self Test/class B(Fast registration, channel 1 (one reference market)) | 10-45 working days | 2-3 months | Verified |
| Fast track 2 — EU Class IIb, IVD LIST B/class C (two independent authorities)(Fast registration, channel 2 (two independent reference authorities)) | 60 working days | 3-5 months | Verified |
| Regular track — all classes (standard route)(Regular registration (new, renewal and change applications)) | 120 days | 4-8 months | Verified |
Newest official AMAR headlines from the daily-refreshed feed — every row links directly to the authority publication.
Official AMAR rules and guidance · 6 of 6 documents linked to official sources
Computed from 29,957 official AMAR registration records · data as of 2026-08-26
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Israel work.
Connect the AMAR route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against AMAR administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to AMAR evidence, notification, timing, and implementation questions.
Assess a current AMAR update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Israel (AMAR).
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