Israel Pharma & Medical Device Market Entry Guide

In this guide

1. Identify the product and the decision
2. Review the evidence you already have
3. Define local roles before signing the operating model
4. Build a dependency-based work plan
5. Plan the work after registration
6. Choose a support model that fits the gap

1. Identify the product and the decision

Record the intended use, product category, manufacturer, available approvals and the activity you want to begin in Israel. For a medicine, identify the formulation, strengths and indications. For a device, identify the intended use, models and classification information. Where classification or the route is uncertain, resolve that question before building a submission timetable.

2. Review the evidence you already have

Create a document inventory and identify who can supply each missing item. Check that product names, manufacturers, versions and intended use are consistent across the available materials. A gap assessment should distinguish a missing document from a question about whether the evidence is suitable for the proposed Israeli submission.

3. Define local roles before signing the operating model

Separate the company structure from the regulated roles. Clarify who will hold the relevant local responsibilities, coordinate submissions, manage product records and communicate with the manufacturer. Where QP, QPPV or other appointed roles are required, arrange them explicitly. Agree access to documents and handover responsibilities so that a later change of provider does not leave the portfolio without usable records.

4. Build a dependency-based work plan

List the decisions, documents and authorizations needed before each step can begin. Assign an owner to each item and agree how authority questions will be routed to the people who can answer them. Use product-specific planning assumptions. A target launch date is a business objective, not evidence that an authority will approve an application by that date.

5. Plan the work after registration

A registration is the beginning of ongoing maintenance. Build a process for tracking renewals, proposed changes, approved product information and communication with global teams. For medicines, the Ministry of Health publishes separate renewal and amendment services. For devices, check the current AMAR guidance for the relevant maintenance activity.

6. Choose a support model that fits the gap

A focused consultation can help resolve a decision. A defined project can address a registration or a backlog. Ongoing outsourcing can support recurring portfolio work, and interim support can cover a temporary capacity need. Choose the model after identifying the work and responsibilities, then agree clear deliverables and reporting.

Keep the product routes distinct
Planning question	Human medicines	Medical devices
Starting regulatory focus	Medicine registration and the relevant application type	AMAR route and product-specific eligibility
Core readiness discussion	Dossier availability, product information and authorized submission responsibilities	Intended use, classification, certificates, manufacturer and local documentation
Continuing work	Renewals, variations and product-information updates	Registration maintenance and changes under current AMAR guidance

Your initial conversation checklist

Non-confidential company and product overview
Existing approvals and a document inventory
Current Israeli registration position, if any
Proposed local entity and other providers
Known deadlines, priorities and open questions
The decision or work package you want help with

This guide is a planning aid, not an exhaustive statement of regulatory requirements. The applicable Ministry of Health procedures and the facts of each product determine the actual route and responsibilities. Official source links are provided below.

Official sources

Consulted when preparing this page on 14 October 2026. Check the applicable current guidance before acting.