Who this service is for
For overseas manufacturers entering Israel, Israeli importers and local teams preparing a device submission. The work is tailored to the device and available documentation, rather than treating all products as eligible for the same route.
Deliverables we can agree with you
- An assessment of the intended device, its classification and the relevant registration questions.
- A document readiness review covering the manufacturer, approvals and supporting product information.
- Coordination of local registration responsibilities and manufacturer authorizations.
- A submission and follow-up work plan, including document gaps and post-registration actions.
How the work progresses
Clarify the product
Identify intended use, models, manufacturer and existing regulatory status before choosing a submission approach.
Check the applicable route
Review the current AMAR guidance and the evidence available for the product. Document any eligibility questions that need resolution.
Coordinate the submission
Align manufacturer documents, local responsibilities and responses, then plan maintenance of the registration.
What to prepare for an initial conversation
Bring a device overview, intended use, model list, existing regulatory certificates and the available quality-system documentation. Also identify who will hold the local responsibilities and who can obtain manufacturer documents.
Service scope
AMAR is distinct from the medicine registration process. Available routes and documentation requirements depend on the device and current guidance. An overseas certificate should be assessed for the proposed route; it is not a blanket guarantee of local registration.
Common questions
What is AMAR?
AMAR is the common name used for Israel's Ministry of Health Medical Device Division. It oversees medical device registration and related regulatory activities. The current Ministry guidance is the starting point for a device-specific assessment.
Can you assess an existing CE-marked or FDA-cleared device?
Yes. Existing approvals and certificates form part of the readiness review. Their relevance to an Israeli application depends on the product, the evidence and the applicable AMAR route.
Can Medicalix help with the local setup as well?
Yes. Local entity and representation arrangements can be assessed alongside the registration plan. The entity's role, authorizations and responsibilities are defined separately for the engagement.
Official sources
- Ministry of Health: current AMAR guidance (Hebrew)
- Ministry of Health: medical device registration (Hebrew)
Consulted when preparing this page on 14 October 2026. Check the applicable current guidance before acting.