Recognised State Classification: How Israel Inherits Device Risk Classes

1. Key takeaways

Israel has no classification rules of its own for devices. AMAR directly inherits the risk classification a device has already obtained in a Recognised State and does not re-determine it. In practice, AMAR accepts CE certificates issued by notified bodies under the MDR (EU) 2017/745 and IVDR (EU) 2017/746 frameworks, regardless of the member state of the notified body, and it also accepts FDA classification and approval decisions. Classification is not something you apply for; it is inherited – on the basis of Section 3(b) and Section 10 of the Medical Equipment Regulations (Registration of Medical Equipment in the Register and Renewal thereof), 5773-2013 (published on 12 June 2013). The internal consistency of the reference-country documents directly determines how smoothly the Israeli review runs. In practice the review is a comparison exercise, so the dossier should be built to match the reference-country approvals verbatim.

• Israel applies no independent device classification scheme; the Recognised State classification is inherited.
• CE certificates under MDR (EU) 2017/745 and IVDR (EU) 2017/746 are accepted from any member state.
• FDA classification and approval decisions are equally accepted.
• The legal basis is Sections 3(b) and 10 of the Regulations 5773-2013, published 12 June 2013.
• Document consistency between the dossier and the reference-country approvals is the main review focus.

2. Legal basis

The reliance mechanism rests on the 2013 regulations, with the definitions and registration conditions in the parent law. The elements cited in this article are set out below.

3. Expert insights

The essence of the Recognised State mechanism is regulatory reliance: Israel outsources the substantive technical assessment to regulators it trusts and performs only a consistency check itself. This design produces three consequences.

First, the classification cannot be self-selected. A company cannot claim a lower classification because Israeli review is faster. The classification comes from the reference-country approval documents themselves; if the reference-country document says IIb, Israel proceeds as IIb.

Second, document consistency becomes the focus of review. AMAR’s practical work is a line-by-line comparison of the dossier against the reference-country approvals: whether the models match, whether the intended use matches, whether the manufacturer name and address match, and whether the certificates are within their validity period. The vast majority of the deficiency requests GRZAN has handled arose from inconsistencies in these items, not from insufficient technical content.

Third, the route without a reference-country approval is significantly more costly. Section 3(c) of the regulations requires that a device not registered in a Recognised State be supported by risk analysis results, a clinical evaluation and a summary of clinical trials; in practice the opinions of two independent experts are also required. This is the watershed in both cost and timeline.

The practical implication for Chinese manufacturers is direct: a product holding only a Chinese NMPA registration and no reference-country approval follows the “no reference state” route in Israel. Obtaining CE or FDA first and entering Israel afterwards is therefore not a strategic preference but route economics.

A final observation concerns the arithmetic of the reliance model. Because AMAR performs a consistency check rather than a fresh technical assessment, the quality of the Israeli outcome is inherited from the quality of the reference-country file: a certificate whose stated intended use, models and manufacturer details are aligned will pass the comparison quickly, while a file with scattered discrepancies will generate rounds of deficiency requests even though the device itself is well documented. Preparing the Israeli dossier is therefore best understood as preparing the reference-country dossier once more, with the specific aim of making every field match the approval documents verbatim.

4. Practical recommendations

• Choose one primary reference state: where several countries have granted certificates, decide explicitly which approval document serves as the baseline for classification and validity, to avoid confusion between multiple certificates.
• Run a document consistency audit: check models, intended use, manufacturer name and address, and certificate validity word by word against the information to be declared.
• Sequence the approvals deliberately: if no reference-country approval exists yet, first calculate the difference between the CE/FDA certification timeline and the Israeli “no reference state” route, then decide the order of work.
• Keep evidence of sales: the reference-state route requires proof that the device has actually been marketed there; sales records, customs declarations and orders must be traceable.

5. Verification checklist

• □ The primary reference state and its approval documents have been identified (CE certificate plus declaration of conformity, or an FDA decision letter)
• □ The reference-state classification is fully consistent with the classification to be declared in Israel
• □ Models, intended use and manufacturer name and address match the reference-country documents word for word
• □ The reference-country approval is valid and matches the period sought for Israeli registration
• □ Evidence of actual sales has been prepared (orders, invoices, customs declarations)
• □ If no reference-country approval exists, preparation of the risk analysis, clinical evaluation and two expert opinions has begun

Regulatory information verified as of 29 October 2026. All law names, numbers, publication dates and article numbers cited in this article were checked on that date against the official Israeli legal database and authoritative public sources; AMAR procedural documents are updated frequently, so before any formal submission please rely on the current version published on the Ministry of Health website.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Israeli market. Our team manages Ministry of Health (MOH) registrations under the Medical Devices Law 5772-2012, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com