🇮🇱 Israel IVD 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.

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.

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.

Obtain approval before implementation in Israel for material changes, for non-material/administrative changes affecting registration-certificate particulars, and for safety-action changes even if certificate particulars are unaffected. A non-material/administrative change that neither affects certificate particulars nor results from a safety action may be implemented immediately with the change application deferred to renewal. A new intended purpose, certain risk-class increases or addition of a product outside the registered model/accessory/system boundary requires new registration before marketing.

A change file includes the completed application PDF, a short explanation of the nature and reason for the change, and the Annex A supporting documents where information differs from the original file. Include manufacturer explanation for an adverse event/FSCA and the appropriate holder declaration: regular-route declaration or fast-route lawyer-affirmed affidavit. Complete all registered device/model and regulatory-certificate details, not only the changed REF or newly added model.

For the separately registered Class I/low-risk IVD group identified by the procedure, the Annex A table permits the listed device-name, model-addition, manufacturer name/address, manufacturing-site detail and holder-detail changes by self-declaration in the registration system, with an updated certificate issued through that declaration route. Actual transfer of registration ownership is expressly excluded from the holder-detail row.

Design-only label changes such as font or colour that do not affect safety, quality or effectiveness do not require a registration-change application. A change to the registered device name for marketing reasons is an administrative change in Annex A, supported by updated regulatory approvals, declaration of conformity, manufacturer declaration/explanation and labels where required. A brand/logo project must first establish which of these two situations applies.

At corresponding IVD risk classes, the official change/fast-track framework permits multiple changes in one change request with every change clearly stated. File material plus any other category as material; non-material plus administrative as non-material. Only non-material/administrative changes may accompany renewal. Wait for an open change request to finish before a further change or renewal request; a dedicated CE-validity update must finish before a later model/product addition. Ownership transfer remains subject to its separate instructions.

One registration-change request may include multiple changes if each is clearly described in the cover letter. An open change request must finish before another change or renewal request. These rules support cumulative brand/name/address/actual-REF assessment, but a transfer of registration holder follows separate ownership instructions. A genuine new legal manufacturer must be assessed against current manufacturer/conformity evidence rather than assumed to satisfy the same-company administrative row.

Annex A treats manufacturer changes including manufacturer name/address without a manufacturing-site change as administrative, and lists manufacturer declaration, a manufacturer explanation that the same company only changed its name, declaration of conformity, ISO 13485 and labels where required. Use this evidence route for an actual same-company rename or office-address change; do not represent a new legal manufacturer as the same company merely because its factory is unchanged.

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).

Under Registration Regulation18 the director may, on the registration holder’s request, issue a certificate that a specified device is registered and permitted to be marketed in Israel. This supports a CFS for the current registration/holder particulars; it does not prescribe automatic reissuance, a change-specific CFS fee, a processing clock or permission for the successor to use an outdated certificate.

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.

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.

A change of registration holder uses the separate ownership-transfer instructions, not the ordinary holder-name/address row. With the existing holder’s consent and at least three months remaining certificate validity, submit a transfer/change request with cover letter, updated electronic form, consent letter, updated manufacturer and importer declarations, the new holder’s ISO9001 (or ISO13485 for a local manufacturer) and business licence. Without the old holder’s consent, the new importer must submit a new registration application with the full required dossier.

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.

Registration Regulation23 requires the trade name, manufacturer and country of manufacture, holder name/address/public contact and the other prescribed identity/safety particulars on packaging or the enclosed leaflet as directed. The general three-language rule is Hebrew, Arabic and English; a non-home-use exemption from some or all language particulars requires the director’s grant on request. A brand, name or holder change must keep the approved label identity consistent.

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.

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.

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.

For eligible fast changes, REG-2024/06 lists administrative and non-material changes at up to 10 working days. Material changes are up to 45 working days in fast 1 (FDA Class II, EU IIa or corresponding IVD self-test/B categories), or up to 60 working days in fast 2 (EU IIb or corresponding IVD List B/C with the required independent approvals). The Class III table has no material-change fast option. Select the actual reference approval, class and change channel; do not substitute a new-registration clock.

Registration Regulations 6(b) expressly applies Regulation 5(a)–(c) to registration-change decisions: decision within 120 days of filing, with the period awaiting requested additional data added to that period; after approval, registration certificate within three working days of the decision. This is a change-specific statutory framework, not a promise that every combined transfer or fast-track case takes 120 days.

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.