🇮🇱 Israel medical device regulatory data

The Medical Equipment Law defines advertising directed to the public (excluding scientific literature), permits the registration of medical equipment to be made subject to conditions restricting the manner or content of its advertising, and authorizes the Director to restrict advertising whose manner or content harms or may harm public health. Except in an urgent public-health case, the affected party must be given an opportunity to present arguments before a restriction is imposed.

Correction with concrete values: a device is registered in the AMAR register for a period not exceeding five years; implants are registered for up to two years; devices registered or permitted for marketing in a recognized state are registered until the expiry of that state's registration/permit, provided the Israeli registration period does not exceed 5 years from the Israeli registration date.

The renewal application must be filed during the 4 months before registration expiry (earlier filing is possible with valid regulatory approvals per the renewal procedure). If a current CE certificate is not yet available at filing, a temporary register registration is set with validity of 6 additional months from the previous registration's expiry. Under the law (sec. 8), a timely-filed application deems the registration extended until the Director-General's decision.

Administrative extension ended 31.12.2024 covering certificates expiring 1.12.2022-30.12.2024 (due to EU extensions): where a renewal application was filed in Caspit with a submission date before 28.2.2025, the register registration is extended until 30.6.2025 unless cancelled or refused. Excludes Class I devices that must be registered in the declaration track; applies to register certificates only, not import approvals; not applicable where a change procedure applies. Fast-track renewals received an updated certificate within 10 working days.

The Medical Device Division — AMAR (אגף ציוד רפואי - אמ"ר) of the Israel Ministry of Health — is the competent authority. It registers medical devices in Israel, issues various types of import permits, monitors marketing, issues export-supporting documents, and operates a registration, supervision and control mechanism over manufacture, import and marketing of medical devices.

Changes to a registered device are classified by the manufacturer as 'material' (מהותי), 'non-material' (לא מהותי) or 'administrative' (אדמיניסטרטיבי); it is the registration holder's responsibility to verify the nature and classification of each change with the manufacturer and file the change application accordingly. Combination rules: several material changes, or material combined with non-material/administrative, are filed as one 'material' application; non-material combined with administrative is filed as 'non-material' (one row for the highest-ranked change). An EU-reclassification increase in risk class requires a 'material' change application. Categories marked '^V' in the change procedure may be filed through the fast 'non-material' channel despite being manufacturer-classified material.

When filing a renewal application (regular or fast track), only 'non-material' and/or 'administrative' change requests may be bundled in addition, with the appropriate declaration wording attached.

A one-time import approval for clinical-evaluation samples is available only if a registration application for the product has already been filed in the register; the import application must state explicitly that the purpose is clinical evaluation. Without a filed registration application, no further one-time approval is given.

Laboratory equipment (IVD, ציוד מעבדתי) is regulated by AMAR under the same rules as medical equipment at the corresponding risk classes (Europe defines 4 risk classes for medical and laboratory equipment; FDA defines 3).

A single application must not combine: a drug-device combination product with a device that does not contain a drug; implants with non-implants; a product of animal/biological origin with a product that is not of that origin; ionizing-radiation-emitting equipment with non-ionizing equipment; or a device intended for a professional user with a device intended for a lay user.

AMAR approval is for finished products only. The application consists of an electronic form (site 'forms' category) plus scanned attachments; separate applications are required per device family/class, and separately for implants, biological products, radiation-emitting devices and different user types.

For Class IIb (or FDA Class II) or Class III products, the application must include the risk-analysis summary as filed with the approving authority and a summary of the clinical trials file. A local manufacturer without recognized-state approvals (Class IIb/III) must additionally attach a risk analysis, a clinical trials file and an opinion from a senior medical figure holding an Israeli practice licence.

Each registration application may include only one of: a single product; a family of products, provided every product has the same risk class; a system whose parts are used together; or a procedure pack of products from the same manufacturer. Models included in the application must be listed on the registration form.

Accepted reference approvals: US FDA; Europe CE plus Declaration of Conformity (Class 1 self-declaration accepted, except sterile/measuring devices which need notified-body CE and a split application); Australia-NZ TGA of the REGISTRATION type only; Health Canada. An application filed with an expired approval is rejected on the spot; all approval dates must be entered DD/MM/YYYY.

Applications are filed by the Israeli registration holder/importer: the dossier includes current importer and manufacturer declarations (importer/manufacturer declaration no older than 1 month; foreign-manufacturer declaration no older than 3 months; personal wet signatures + company stamp + signer's role) and the local business licence number and expiry per regulation 1.3 issued by the local authority.

On change of the registration holder/importer, the new registration holder's declaration replaces the old importer declaration; in the fast track a lawyer-signed affidavit of the appropriate wording must be filed.

AMAR issues one-time import approvals (e.g. for use in a private clinic or for evaluation) and periodic (annual) import approvals; importing for marketing requires the product to be registered in the Medical Equipment Register. Currently no fee is required to obtain import approvals; import questions go to Amar.Importation@moh.health.gov.il.

From 8.2.2023, applications to import biological-source materials intended for laboratory use only (not for use in humans) are approved on the basis of an importer declaration: a full application in the Maslul (מסלו"ל) system plus a signed importer declaration per the attached guide.

If the register registration is not renewed, the registration holder cannot obtain import approvals.

For devices intended also for the home (non-professional) user, the application must include the leaflet, a scanned packaging sample and user instructions in Hebrew and Arabic, compared against the approved (English) source approved by the foreign authorities; additional languages are permitted; translation must be done by external translation companies with a certification document from them.

Medical Equipment Law 5772-2012 (חוק ציוד רפואי, התשע"ב-2012), published in Sefer HaChukim 2357 p. 394 on 14.5.2012, is the primary legislation. Medical equipment may be manufactured and marketed only if it is registered in Israel in accordance with registration conditions, or if it is listed in the Second Addendum to the law (exempt categories).

The AMAR procedures — Registration in the Medical Equipment Register, Renewal of Registration, and Change of Registration — entered into force on 1.1.2025, each with new declaration/affidavit wording for the regular and fast tracks, published in the 'forms for registration' collector on the ministry site.

For Class I medical devices a Post-Market Surveillance Report (PMSR) is required, detailing the monitoring and audit activities performed to improve the device's safety and quality and to correct deficiencies found. The ministry's supervision page further requires monitoring and audit activities to evaluate registered devices and improve their safety and quality, with reporting to AMAR.

Registration applications to AMAR are submitted through the ministry's Caspit (כספות) portal (launched 25.1.2017, replacing email-only submission); the 1.12.2024 extension announcement confirms renewal applications are filed in the Caspit system and an 'application submission confirmation' with a submission date is issued.

A register-registration application must be filed electronically as an electronic registration form (PDF, version 9.0 recommended) plus a compressed zip of the required accompanying documents not larger than 250MB, and must be sent through the ministry Caspit (כספות) portal only.

Applications are an electronic form plus scanned attachments sent by email to amar@moh.health.gov.il; email size must not exceed 15MB (larger submissions are split into several emails, up to about 40 files). If no acknowledgment is received within 7 days (excluding concentrated government holiday periods), the application must be resent; during that period the applicant receives an intake confirmation with a reference number and device number, or a rejection notice.

Annex 1 of REG-2024/03 is the new-applicant declaration for medical devices and IVDs on the regular registration track. The current Word (word) declaration file for download and completion is published on the ministry website; the PDF annex itself is the pointer, not a fillable form.

ISO 13485 certificates are required for every manufacturer in the product's supply chain; alternatively, valid GMP certificates may be attached. ISO 5001 certificates are required for other participants in the supply chain (e.g. subcontractors/suppliers). The official Q&A clarifies ISO 13485 is submitted for the manufacturer and/or the manufacturing sites of the device.

AMAR publishes a list of recall notices (קריאות להחזרה) for medical devices on its site; the law empowers the Director-General to order marketing restrictions and recalls of registered devices (Chapter C of the law, in the official text held).

Declaration track (מסלול רישום בהצהרה), launched 3.9.2023: self-declaration by the registration holder and/or importer for low-risk (Class I incl. Is/Im/Ir) devices and low-risk IVDs that are registered and marketed in recognized states only; the register registration certificate is sent immediately after the application is accepted in the registration system, and no later than 48 hours. It is the first stage of the 'Enabling Regulation' (רגולציה מאפשרת) programme.

Fast track (מסלול רישום מהיר), launched 2.6.2024 as the second stage of the 'Enabling Regulation', with two channels: fast 1 (ערוץ מהיר 1) — Class II with FDA approval (510(k)/De Novo), EU Class IIa with a recognized-state approval, or IVD Self Test (IVDD)/class B (IVDR), all requiring 4 months of marketing; new registrations handled within up to 45 working days and renewals within up to 10 working days. Fast 2 (ערוץ מהיר 2) — EU Class IIb or IVD LIST B (IVDD)/class C (IVDR) relying on registrations from two independent regulatory authorities (e.g. EU and FDA) with 6 months of marketing; new registrations and renewals handled within up to 60 working days. Change applications in the fast track are also open to Class III and high-risk IVDs (non-substantial changes up to 10 working days; the substantial-change option does not exist for Class III). Requires a lawyer-affirmed affidavit (תצהיר מאומת ע"י עו"ד); the channel is chosen by the highest classification in the application file.

Regular track (מסלול רגיל): the standard route for new, renewal and change applications, with a published handling target of 120 days. Track choice is by product risk class; Israeli-manufacturer devices registered and marketed in a recognized state may also use the fast track.

A private individual or physician fills their ID-number details instead of importer details on the import application; attaches a prescription or physician guidance letter for purchasing the device; and attaches a declaration that the import is for personal use only. No regulatory approvals need be attached.

Devices listed in the Second Addendum to the Medical Equipment Law are exempt from registration: medical equipment may be manufactured and marketed only if registered (and per registration conditions) or if listed in the Second Addendum.

An application may be transferred from the regular track to the fast track via a cover letter requesting the transfer, a signed affidavit and an updated marketing-data document. Document requirements are identical across tracks; the difference is the required declaration document (fast track requires a lawyer-affirmed affidavit). If no intake confirmation arrives within 7 days, the application must be resent.

The AMAR register (פנקס אמ"ר) at registries.health.gov.il/MedicalDevices is the database of all approved medical accessories and devices, with open public access.

The registration holder must perform monitoring and audit actions to evaluate registered devices and improve their safety and quality, report their performance to AMAR, and report every special event connected to the use of a registered device that comes to their knowledge, in three categories: (1) a severe malfunction of the device that occurred in Israel or another country and could endanger a patient's health; (2) use of the device that caused, or is suspected of having caused, harm to a patient's physical or mental health that is not expected in the normal course of the disease or treatment, or use that caused significant harm or a patient's death in Israel or another country; (3) an action taken by a health authority worldwide or a notice published by a manufacturer, registration holder or health authority regarding the device, its marketing and use, or new information published in the main scientific literature regarding the device's safety.

Reports of monitoring actions and special events are submitted to the Medical Device Division (AMAR) of the Ministry of Health by email to amar.pms@moh.health.gov.il; a dedicated malfunction-report form for accessories and medical instrumentation exists for local manufacturers and importers.