Israel Medical Device Registration Amar Registration Service
An AMAR registration service is an execution project: identify the Israeli registration holder, freeze the intended use and model scope, select the correct submission route, assemble the supporting evidence, send the prescribed files through the Ministry of Health Medical Device Division’s secure portal, and manage queries and later changes. The application is not an import permit. A CE mark or FDA clearance is evidence for assessment, not by itself an Israeli registration.
AMAR filing preflight: holder, intended use and model scope
First obtain the manufacturer’s exact intended purpose, device/IVD classification in the reference jurisdiction, model-and-accessory list, legal manufacturer identity, approvals and expiry dates, evidence of sales in recognized countries, and the proposed Israeli registration holder. Confirm whether a similar model is already registered and whether the planned grouping is one product, a same-class family, a functional system, or a dedicated procedure kit. If the device status itself is disputed, seek a classification decision rather than submitting on assumption.
Choose the AMAR declaration, Fast 1, Fast 2 or regular route
Use the following as a pre-filing gate, not as an automatic eligibility promise. For the precise device category and current documentation requirements, apply the Ministry procedures REG-2023/04, REG-2024/06 and REG-2024/03.
| Candidate | When it may fit | Execution consequence |
|---|---|---|
| Declaration | Eligible Class I devices and low-risk IVDs registered and marketed in recognized countries under the declaration procedure. | Prepare the special declaration, appropriate regulatory evidence and route-specific ZIP; do not file a standard dossier in its place. |
| Fast 1 | FDA Class II with qualifying 510(k) or De Novo authorization and evidence of US marketing during the previous four months; or EU IIa, IVDD Self-Test or IVDR Class B with qualifying authorization and marketing in a recognized country during the previous four months. | Check the authorization type and evidence of recent marketing in the required country, not merely a generic worldwide sales claim; use Fast 1 coding. |
| Fast 2 | EU IIb, IVDD List B or IVDR Class C with authorizations from two independent regulators and marketing in a recognized country during the previous six months. If FDA is one authority, sales in the US are not separately required when the product is marketed in the other recognized country. | Confirm independent authorizations and the six-month recognized-country marketing evidence; use Fast 2 coding. |
| Regular | Devices outside the declaration/fast criteria, or cases needing ordinary assessment. | Assemble the full risk- and product-dependent evidence set under REG-2024/03; do not claim expedited handling. |
The regular pathway is not an automatic authorization or an exemption from the underlying registration requirements. If no qualifying foreign authorization can be evidenced, the applicant must establish the legal and evidentiary basis for regular review with the Ministry before submitting; failure of the Fast criteria alone does not prove the device is registrable.
The fast-track procedure publishes up-to-45-working-day review for Fast 1 new filings and up-to-60-working-day review for Fast 2 new filings. These are published processing periods, not approval guarantees; completeness requests and route redirection can change actual elapsed time.
AMAR dossier ownership: manufacturer, Israeli holder and filing support
| Participant | Filing responsibility | Control to retain |
|---|---|---|
| Manufacturer | Supplies accurate intended use, technical file extracts, QMS evidence, valid foreign authorizations, label/IFU and marketing history. | Checks each model and certificate against the signed declaration; promptly communicates safety or design changes. |
| Israeli registration holder / applicant | Checks route and scope, provides its own corporate and quality evidence, signs the applicable holder declarations and submits through the authorized portal access. | Keeps submission/response records and monitors the registered scope and renewal or change status. |
| Filing support provider | Builds the document index, performs consistency review, prepares the form and ZIP, coordinates corrections and follow-up. | Does not replace the legally accountable holder or promise acceptance by the Ministry. |
Build the AMAR application dossier
REG-2024/03 and the Ministry’s portal instructions govern the application PDF and supporting ZIP sent through the secure AMAR vault. Before upload, use the current official form and check its validation, filenames, attachment structure and applicable size limits; do not rely on a legacy form version or a fixed limit quoted elsewhere. Requirements depend on device risk, IVD status and route. The following field-to-evidence check is a working quality-control aid, not an additional Ministry form.
- Identity and scope: registered applicant name/company number, manufacturer, product and model identifiers, same-class grouping justification, manufacturer-defined purpose and indications.
- Reference-country authorizations: applicable CE / EU conformity documents, FDA decision or other recognized approval, clear issuing entity, covered models, current validity and any legitimate EU transitional extension evidence.
- Applicant and manufacturer documents: current corporate evidence, relevant holder declaration or affidavit and applicable ISO 13485/GMP quality-system certificates, including relevant supply-chain sites where required.
- Technical and clinical/safety evidence: device description, mechanism and risk-specific technical support; attach electrical safety, sterilization or other test reports where applicable, rather than assuming every report is universal.
- Label and instructions: manufacturer-controlled packaging labels, instructions for use, warnings and indication statements matching the application.
- Marketing and surveillance evidence: current world-sales statement on the Ministry template where applicable, marketing period proof for a fast route, and renewal surveillance materials when that specific procedure requires them.
| Field or claim in filing | Evidence to reconcile | Release gate before sending |
|---|---|---|
| Applicant and holder identity | Israeli holder corporate record, company identifier and the appropriate signed declaration | Same legal entity on form, declarations and portal access |
| Device scope and intended purpose | Manufacturer model/accessory schedule, labels, IFU and foreign decision annexes | Every model and claimed use falls within the documentary scope |
| Fast-route evidence | Type and validity of foreign authorization, independent regulator for Fast 2, and dated marketing evidence for the required country/period | Do not select Fast without proof; check regular-route eligibility separately. |
| Safety and quality supporting files | Applicable QMS record, specific technical/test support and controlled label versions | No expired, missing, wrong-model or unexplained document |
Submit, track and close Ministry queries
- 1 — Scope lock. Reconcile the signed device/model list, declared uses, classification and foreign evidence; agree who is the registration holder before naming the applicant.
- 2 — Route and format check. Download current forms and declarations from the AMAR collections. Choose new registration versus renewal versus change; choose exactly the appropriate declaration, fast or regular path.
- 3 — Assemble and validate. Complete the electronic PDF fields, enter the correct company identifiers and regulatory document validity, index attachments in the required ZIP/folder structure and verify size, filenames and signatures.
- 4 — Secure submission. The holder or its authorized submitter sends the application via the AMAR secure portal. For fast filings, the relevant filing-type codes include 51 (new), 52 (change), 56 (renewal), 54 (additional material). Do not substitute an old email-filing instruction.
- 5 — Query loop. Log the receipt and any Ministry deficiency letter, assign each response to a document owner and send the correction in the specified transaction. REG-2024/06 provides 30 working days for requested supplements in an accepted fast-track file; an unanswered request can be closed.
- 6 — Decision and handover. Check the actual certificate/register entry against manufacturer, models, indications and validity; hand over the decision, submission archive and maintenance calendar. A transmitted ZIP alone is not approval.
AMAR filing rejection risks: route evidence, PDF/ZIP and response deadlines
| Trigger | Why it matters | Before sending |
|---|---|---|
| Mismatched model or intended-use wording | The scope on the form may not be supported by the foreign authorization or label. | Run a model-by-model crosswalk, and match the manufacturer’s exact indications. |
| Fast route without qualifying approvals or market history | The Ministry may move the file to regular review or reject the fast submission. | Document each prerequisite and correct route codes; verify independence for Fast 2. |
| Missing certificates, signatures or wrong ZIP/PDF fields | Technical incompleteness or portal validation can interrupt intake. | Check document expiry, holder affidavit version, size and mandatory fields. |
| Untracked Ministry request | A response deadline may be missed and the filing closed. | Maintain receipt IDs, an owner and dated response log. |
AMAR post-approval controls: changes, renewal and separate import approval
An approval is limited to the registered product and conditions. Before changing intended purpose, increasing the risk class, adding a product not qualifying as a model/accessory, or changing a medicinal constituent of a combination device, check REG-2024/08: these examples may require a new registration rather than a simple amendment. Other changes must be classified and supported under that procedure. For renewal, review the certificate, current reference approvals, quality records and surveillance report/declaration required by REG-2024/07; avoid assuming that a pending filing automatically authorizes a particular shipment.
For Class II and III devices (including EU IIa/IIb) and comparable-risk IVDs, REG-2024/07 instructs the holder to file renewal during the four months before AMAR registration expires. A late renewal may not be processed before expiry. Check the renewal rules separately for declaration-route Class I and low-risk IVD devices.
AMAR registration and customs/import approval are distinct workflows. The Ministry’s import guide states that a periodic import approval for goods within its scope is requested through the separate Maslul+ system, with the customs tariff classification relevant to the responsible authority. An AMAR registration certificate alone should not be represented as a complete customs clearance. The Ministry announced that AMAR register new/change/renewal applications have no registration fee from 15 August 2022; this does not establish that consultancy, testing, customs or logistics are free.
Where strategic advice ends and filing execution begins
This page owns the filing pack, portal sequence, corrective responses and post-decision file handover. For a preliminary classification or evidence-gap strategy, see AMAR regulatory consulting. For the wider Israeli market-access route beyond the medical-device filing, see product compliance and market-access services in Israel. Neither page substitutes for the Ministry’s current Hebrew procedure.
Questions about specific AMAR filings
Can an EU CE certificate be uploaded as the entire AMAR application?
No. A foreign authorization supports the relevant route, but the AMAR form, applicant declarations, quality/manufacturer documents and applicable device evidence must still be supplied. Check covered models and the CE validity or transition basis.
Can one AMAR filing cover a family and accessories?
Possibly, if the grouping meets the procedure’s rules; the regular procedure describes single devices, same-risk-class families, functional systems and dedicated kits. List every covered model. Different classes or unsupported additions can require a different submission.
Does FDA Class II clearance automatically qualify for Fast 1?
No. The exact FDA authorization type and applicable marketing-history condition must be verified under REG-2024/06; classification alone is insufficient. For FDA Class II Fast 1, verify the 510(k) or De Novo pathway and marketing in the United States during the previous four months.
What happens when AMAR requests additional documents on a fast-track file?
Assign each request, use the proper supplement route and respond within the period stated in the official procedure or notice. The fast-track guidance specifies 30 working days for supplements; failure can close the file.
Can a change of intended use be filed as a minor amendment?
Do not assume so. REG-2024/08 identifies a change of intended use among changes requiring a new application. Assess the revised scope before marketing it.
Official procedure sources
Ministry of Health: