AMAR (Israel Medical Device Division)

AMAR is the Medical Device Division within Israel's Ministry of Health. Its Hebrew name is commonly transliterated as the Department of Medical Devices, and the acronym AMAR appears frequently in English-language regulatory practice. The division manages medical device registration and oversight for products supplied in Israel.

Is AMAR the same as the Israel Ministry of Health?

AMAR is not a separate ministry. It is the specialized medical device unit within the Ministry of Health. The Ministry is the legal authority, while AMAR is the operational division manufacturers and Israeli registration holders generally deal with for device registration, database records, changes, and related questions. You may also encounter English references to the Medical Devices and Accessories Division.

What does AMAR regulate?

AMAR oversees medical devices and IVDs, maintains the medical device registry, reviews market-entry submissions, and supports post-market controls. Its work includes changes to registrations, safety reporting, recalls, and other lifecycle actions. Requirements depend on device risk, intended use, technology, and prior authorization history.

Does a foreign manufacturer need an Israeli registration holder?

A manufacturer outside Israel generally appoints an Israeli Registration Holder, often called an IRH, to submit the application and serve as the local regulatory contact. The IRH has important responsibilities for authority communications, maintenance, vigilance, and recalls. Agreements should address control of the registration, access to records, change reporting, and transfer if the business relationship ends.

Does AMAR recognize approvals from other markets?

Prior authorization from a recognized regulatory jurisdiction can be important in an Israeli filing and may support an abridged or reliance-based approach when the product and evidence qualify. It does not eliminate the need for an Israel-specific application, local holder, Hebrew labeling assessment, and ongoing compliance. Eligibility should be evaluated against the current Ministry route rather than assumed from the presence of a CE mark or US clearance alone.

How can I search Israel's medical device registry?

The Ministry of Health provides an online medical device registry. A search can help verify public registration information, but manufacturers should also check the approved scope, models, indications, holder, and validity in their authorization records.

How do I contact AMAR?

The Ministry lists the Medical Device Division email as amar@moh.health.gov.il. General government health-service support is available through the Ministry's registry service page, which also lists current telephone and address information.

Related Israel regulatory topics

See our Israel medical device registration overview for the practical market-access pathway.