AMAR Israel Medical Device Registration

Medical devices and in vitro diagnostics in Israel are overseen by the Ministry of Health's Medical Device Division, commonly called AMAR. AMAR manages registration records, market-entry review, changes, and post-market actions. The Ministry provides public information through its health registries service and an online medical device registry.

Israel classification and reliance pathway

Israel frequently uses the classification and authorization history of recognized reference jurisdictions when assessing a device. A CE mark, FDA authorization, or approval in another recognized market can support a reliance or abridged route when the product and evidence qualify, but it does not replace an Israel-specific application. The intended use, models, manufacturer, sites, and labeling presented in Israel must remain consistent with the supporting approvals.

The route should be confirmed before dossier preparation because products without suitable reference authorization, novel technologies, software, and IVDs may require different evidence or review. Claims that Israel simply copies one foreign classification system are too broad; the accepted reference evidence and current Ministry requirements must be evaluated for the specific device.

Israeli Registration Holder

A foreign manufacturer generally appoints an Israeli Registration Holder (IRH) to file and maintain the registration and serve as the local regulatory contact. The IRH supports authority questions, changes, renewals, complaints, vigilance, and recalls. The agreement should define ownership and access to the dossier, reporting timelines, change control, commercial independence, and how a registration can be transferred if the relationship ends.

Dossier, labeling, and lifecycle

A submission commonly includes administrative and authorization documents, manufacturer and site details, quality-management-system certificates, reference-market approvals, intended use, classification, device descriptions, labeling and instructions for use, declarations of conformity, and technical, clinical, or performance evidence proportionate to risk. Hebrew labeling and local information should be assessed against the current requirements rather than added only after approval.

After registration, the manufacturer and IRH must keep the approved scope, models, sites, certificates, and labels current. Complaints, adverse events, field safety corrective actions, and recalls require coordinated local procedures. Design, intended-use, software, manufacturer, site, or labeling changes should be evaluated before implementation to determine whether AMAR notification, approval, or a new application is needed. Public registry data is useful for verification, but the issued authorization remains the controlling record for scope and validity.