Three Registration Routes for Medical Devices in Israel

1. Key takeaways

Israel’s current registration framework was established by the reform plan issued in August 2023, which created three pathways: the Declaration Route (for Class I devices and IVD Class A laboratory equipment, with registration completed within 48 hours), the Fast Track (Fast 1 at approximately 45 working days and Fast 2 at approximately 60 working days), and the Standard Route (an official target of 120 calendar days, with actual processing commonly taking 4–6 months (practical estimate)). The three decisive variables that determine pathway selection are, in order: whether a reference-country approval exists, the provable length of time on the market, and the number of reference countries. The risk classification of the device is only a second-order variable in this decision.

This ordering matters for planning. Many applicants assume that the risk class alone dictates the route, yet under the Israeli system a lower-risk device without any reference-country approval will still enter the Standard Route, while a higher-risk device holding the right combination of approvals and market history may proceed through a Fast Track. Understanding how the three variables interact is therefore the foundation of every realistic registration timeline for the Israeli market.

2. Legal basis

The key legal instruments underpinning the three routes are summarised below, together with their parent legislation and the reform programme that produced them.

3. Expert insights

The division of labour among the three routes is, in essence, a reallocation of review resources according to risk. The Declaration Route shifts the burden of proof entirely onto the registration holder, because the 48-hour turnaround is a system confirmation rather than a passed technical review. The Fast Tracks perform a consistency check combined with a limited review. Only the Standard Route carries out a full substantive technical assessment of the dossier.

From this structure follows one practical conclusion: the pathway is not “applied for”; it is “calculated”. The route is derived from the evidence the applicant already holds, not chosen by preference, and GRZAN determines the route using the following sequence. Because the sequence is strictly ordered, skipping a step — for example, assuming a fast-track route before confirming the reference-country position — produces a schedule that collapses at the first question from the authority.

Step one: check whether a reference-country approval exists. If there is no reference-country approval, the product goes directly into the Standard Route, and the applicant must submit a risk analysis, a clinical evaluation and a summary of clinical trials (Article 3(c) of the Regulations); in practice two independent expert opinions are also required. This is the only step in the sequence that ignores classification altogether.

Step two: look at the market history. Once a reference-country approval is in place, the commercialisation history becomes the dividing line: 4 months of market presence corresponds to Fast 1, and 6 months corresponds to Fast 2. The market history must be provable — purchase orders, invoices and customs declarations must match the model and the period in question.

Step three: count the reference countries. Fast 1 requires at least 1 reference country; Fast 2 requires 2 different reference countries.

A common misjudgement is to place the whole of “Class II” into Fast 2. The correct approach is to distinguish: FDA Class II and EU Class IIa fall under Fast 1, whereas EU Class IIb (and IVDR Class C) falls under Fast 2. The two tracks differ visibly in both the review time limit (45 versus 60 working days) and the volume of evidence required.

The consequence of this ordering for portfolio owners is that the same product can sit on different routes in different situations. A company adding a new model to an established family inherits the family’s reference-country position; a company entering Israel for the first time with no foreign approvals cannot shortcut its way into a fast track at any risk class. Reading the three variables correctly before filing is therefore the cheapest schedule protection available under the Israeli system.

4. Practical recommendations

• Run the three-step sequence rather than judging by product name or intuition, and record the outcome of the determination in the project initiation file.
• Collect market-history evidence in advance: start archiving sales and customs records from the reference countries six months before the decision to enter Israel.
• Manage timelines on two tracks — the official target plus the practical range: use the practical range for external commitments and the official target plus a buffer for internal scheduling.
• Build in a buffer for Jewish holidays: Israeli public holidays and religious festivals are dense on the calendar, and review schedules need to work around them (practical estimate).

5. Verification checklist

• □ Reference-country approval documents confirmed valid and consistent in model and intended use
• □ Route determination completed using the three-step sequence of reference-approval presence, then market history, then number of reference countries
• □ Market-history evidence (orders, invoices, customs declarations) covers the 4-month or 6-month requirement
• □ Distinction made between FDA Class II / EU IIa (Fast 1) and EU IIb / IVDR Class C (Fast 2)
• □ Dossier format requirements checked against the current REG document (REG-2024/03)
• □ Project schedule includes buffers for holidays and deficiency responses

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