The four registration routes
Declaration for Class I (immediate), Fast-Track at 45–60 business days, and the 120+ business-day Standard Route.
Free field guide · PDF
Israel AMAR Medical Device Registration2026 Field Guide
The four registration routes, the reference-market reliance, and the IRH rule — with the submission practice you need.
- Declaration Route
- Immediate
- Fast-Track review
- 45–60 days
- Standard Route
- 120+ days
Sourced from AMAR guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — AMAR guidance and verified 2026 publications.
Reference-market reliance
No independent Israeli classification — registration is built on prior approval in Australia, Canada, Europe, or the USA.
The IRH rule
Foreign makers cannot file directly: an ISO 9001-certified Israeli Registration Holder owns the registration via AMAR SAFE.
Sources & scope
- eranyona.com, Medical device registration and submission in Israel (2026 tracks).
- emergobyul.com, Israel — AMAR Medical Device Registration.
- adherent.com, Medical Device Regulation in Israel (2026).
This guide is market-access intelligence, not regulatory or legal advice. AMAR timelines, guidance, and review practice change — professional review is required before business use.
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