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Israel Medical Device Registration

Ministry of Health - Medical Devices Division (MOH-MDD) approval timelines and requirements

2-4 months
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
Israel Authorized Representative

Israel Medical Device Registration Overview

Israel medical device registration through MOH-MDD typically takes 2-4 months for Class A devices. The official MOH-MDD target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Israel uses a 4-class (A, B, C, D) - GHTF aligned risk-based classification system. Foreign manufacturers must appoint a Israel Authorized Representative to register devices in Israel. Registration is valid for 5 years.

Registration Timeline by Device Class

Israel uses a 4-class (A, B, C, D) - GHTF aligned risk-based classification system.

Class A

Registration

Low Risk
Official
1-2 months
Realistic
2-4 months
With Prior Approval
1-2 months

Accelerated with: FDA, EU CE Mark

• Expedited with US/EU approval

Class B

Registration

Medium Risk
Official
2-4 months
Realistic
3-6 months
With Prior Approval
2-3 months

Accelerated with: FDA 510(k), EU CE Mark

• Prior FDA/EU approval significantly expedites

GMP/QMS Required

Class C

Registration with clinical data

High Risk
Official
4-8 months
Realistic
6-12 months
With Prior Approval
3-6 months

Accelerated with: FDA 510(k), EU CE Mark

• Clinical evidence required

Clinical Trial RequiredGMP/QMS Required

Class D

Full Registration

Highest Risk
Official
6-12 months
Realistic
9-18 months
With Prior Approval
5-10 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Extensive clinical data required

Clinical Trial RequiredGMP/QMS Required
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Israel registration.

FDA 510(k)
Expedited review pathway
2-4 months
EU CE Mark
Expedited review pathway
2-4 months
MDSAP
Not formally recognized
None
Key Requirements
  • Israel Authorized Representative (for foreign manufacturers)
  • Hebrew labeling
  • ISO 13485 certification
  • Free Sale Certificate
Registration Validity:

5 years

Registration Process Flowchart

Israel Medical Device Registration Process

Step-by-step MOH-MDD registration process. Total estimated timeline: 2-4 months.

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 months

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.
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.