Combination Product Classification: Device or Medicinal Product

1. Key takeaways

Article 9 of the Israeli Regulations provides that where a device contains a preparation, the Director decides whether it is registered as a combination product under the device route or registered as a medicinal product; the criteria are the principal mode of action (PMOA) and the principal intended use. The applicant may submit a preliminary classification request to the Medical Equipment Division of the Ministry of Health, and the Director shall decide within 30 working days. This determination should be made up front — choosing the wrong pathway means redoing the entire documentation set, together with every downstream plan that depended on it.

The stakes are high because the two regimes are not merely different files but different worlds: different reviewers, different evidentiary expectations and different timelines. A company that discovers mid-project that its product is regulated as a medicinal product loses not only the months already spent but also the strategic assumptions behind its market-entry plan.

The trigger for the rule is narrow in wording but wide in practice. It applies wherever a device contains a preparation, and the related provisions extend comparable treatment to devices processing blood products and devices containing animal-derived materials. Wound-care products with drug coatings, drug-eluting combination devices, diagnostic products with reactive components — any of these can trip the boundary, so the question should be asked for every product line, not only for the obvious candidates.

2. Legal basis

The classification mechanism rests on Article 9 of the regulations, supported by the definitions and staffing provisions of the parent law, as summarised below.

3. Expert insights

The boundary determination for combination products must be made up front because the two pathways differ entirely in their documentation systems, review departments and timelines. Registration as a device goes through AMAR’s reliance mechanism (reference-country approvals can be used); registration as a medicinal product enters the drug registration system, where the reference-country reliance rules, stability data requirements and review timelines are all different. Once the dossier has been prepared on the wrong track, the rework cost approaches that of starting over, and the internal credibility cost of a missed market-entry window is often just as damaging.

The framework given by Article 9 is the two-element test of principal mode of action plus principal intended use. This aligns with the approach of Article 2 and Annex VIII of the EU MDR, so companies holding an MDR combination-product classification outcome have a good chance of a consistent determination in Israel — but an Israeli written determination should still be obtained; it should not simply be presumed. The written determination is also what protects the project if the reviewer roster changes or the product is amended later, since the argument then rests on a documented decision rather than on an informal understanding.

One easily overlooked consequential requirement: Article 22 of the Regulations places devices containing a preparation, devices processing blood products, and devices containing animal-derived materials among the categories that must be handled by a qualified professional, and that professional may be a licensed pharmacist. This means the licence-holding entity for a combination product faces additional staffing requirements.

The staffing point deserves early attention because it can affect the corporate structure of the application itself. If the intended licence holder does not employ, or have engaged, a professional who satisfies Article 22 — including in the licensed-pharmacist form — then the entity choice for the registration may need to change before the dossier is filed, not after. Checking this alongside the preliminary classification request avoids discovering a structural obstacle at the moment of submission, when the whole filing calendar is already committed.

4. Practical recommendations

• Request the preliminary classification before filing: trade 30 working days for pathway certainty, avoiding months of investment on the wrong track.
• Submit a mode-of-action argument: explain the principal mode of action by contrasting pharmacological, immunological and metabolic action with physical action, attaching reference-country classification outcomes as support.
• Confirm the staffing qualifications of the licence holder: devices containing a preparation require a licensed pharmacist or another qualified professional listed in Article 22 of the Regulations, and this should be verified before the dossier is assembled.
• Archive the determination and reuse it: the classification determination is also valuable reference material for boundary arguments in other markets.

5. Verification checklist

• □ Determined whether the product contains a preparation, a blood-product-processing component or animal-derived materials
• □ Principal mode of action (PMOA) argument completed and submitted in writing
• □ Preliminary classification request filed, and the Director’s written determination obtained
• □ Reference-country (EU or FDA) combination-product classification outcome submitted as attachment
• □ IRH staffed with the qualified professional required by Article 22 (including the licensed-pharmacist case)
• □ Dossier system organised according to the determined pathway (device or medicinal product)

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

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 MOH registration applications across risk classes, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com