Israel medical device registration timeline

Source-linked clocks

Ministry of Health - Medical Devices Division (MOH-MDD) review clocks and end-to-end planning ranges, using the Reference-market classes: EU I, IIa, IIb, III; US FDA I, II, III (FDA prevails on conflict) classification system.

4 pathways4 of 4 clocks verifiedvalidity Not a fixed Israeli term. The registration runs to the expiry of the underlying reference certificate, which the applicant must enter on the application. Where the reference approval carries no expiry, as with an FDA clearance, REG-2024/06 requires an expiry date of five years from the date of submission, which is where the commonly quoted five-year figure comes from.MDSAP not acceptedreviewed 2026-08-30gov.il

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Declaration track — Class I (incl. Is/Im/Ir) and low-risk IVDs(Declaration based on prior registration in a recognized state) REG-2023/04: the registration certificate is sent immediately after the application is accepted in the registration system, and no later than 48 hours; non-conforming submissions receive an automatic rejection reply within 4 hours.	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)) REG-2024/06: new registrations handled within up to 45 working days; renewals within up to 10 working days; substantial changes up to 45 and non-substantial changes up to 10 working days.	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)) REG-2024/06: new registrations and renewals handled within up to 60 working days; substantial changes up to 60 and non-substantial changes up to 10 working days.	60 working days	3-5 months	—	Verified
Regular track — all classes (standard route)(Regular registration (new, renewal and change applications)) AMAR publishes a handling target of 120 days for regular-track new, renewal and change applications; devices not eligible for the declaration or fast tracks use this route.	120 days	4-8 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Israel Medical Device Registration Process

Step-by-step MOH-MDD registration process. Total estimated timeline: 1-2 days.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MOH-MDD. Appoint a Israel Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MOH-MDD including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MOH-MDD reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 days

In-depth technical assessment of device safety and performance. MOH-MDD may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MOH-MDD issues Israel market authorization certificate.

Summary: The Israel medical device registration process through Ministry of Health - Medical Devices Division (MOH-MDD) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

FDA 510(k)/De Novo/PMAIsrael does not run an independent assessment: a recognized-state approval is what makes a device registrable at all, and which one you hold decides which track you land in. A US clearance plus four months of US marketing puts a Class II device on fast track 1, and a US clearance paired with an approval from a second independent authority puts an EU Class IIb device on fast track 2 without needing actual marketing in the US.Fast track 1 is up to 45 working days and fast track 2 up to 60, against the 120-day regular-track target

EU CE MarkA recognized-state CE certificate puts a Class I device on the declaration track and an EU Class IIa device or IVDD Self Test / IVDR class B on fast track 1, in both cases with four months of marketing in the recognized state. EU Class IIb and IVDD LIST B / IVDR class C need the CE certificate plus a second independent authority for fast track 2.Declaration track is up to 48 hours and fast track 1 up to 45 working days, against the 120-day regular-track target

Health Canada or Australia TGAREG-2024/06 restricts the regulatory certificate types that can be entered on an application to CE, FDA, FDA K510, Australian Ministry of Health and Canadian Ministry of Health, so a Canadian or Australian approval is a first-class reference certificate on the same terms as a US or EU one.Same track placement as the US and EU certificates above

Second independent regulatory authority (fast track 2)AMAR defines an independent authority as a recognized authority whose own registration does not itself rest on a registration in another recognized state, and puts the burden on the registration holder to check with the manufacturer how each foreign registration was actually granted. Two approvals from the same underlying assessment do not qualify.Opens fast track 2 at up to 60 working days for EU Class IIb and IVD LIST B / class C

MDSAPNot a recognized certificate type under REG-2024/06 and not a route into any track.None

Key requirements

Israel Authorized Representative (for foreign manufacturers)
Hebrew labeling
ISO 13485 certification
Free Sale Certificate
Fast-track applications require an affidavit; declaration-track Class I eligibility requires prior registration in a recognized state
Change applications carry their own clocks on both fast tracks: administrative changes up to 10 working days, non-substantial changes up to 10, substantial changes up to 45 on fast track 1 and up to 60 on fast track 2
A renewal filed without a current CE certificate is entered in the register temporarily, valid for six months beyond the expiry of the previous registration, so the certificate gap does not take the device off the market

Primary regulator sources

gov.il · AMAR REG-2023/04 — declaration-route registration (certificate within 48 hours) gov.il · AMAR REG-2024/06 — fast-track registration handling times by channel gov.il · AMAR Q&A — registration and import of medical equipment (regular-track handling target of 120 days)

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against MOH-MDD publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:israel:declaration-track