Israel Fast Track 1: 45 Working Days Review

1. Key takeaways

Israel’s Fast Track 1 applies to devices classified as FDA Class II or EU MDR Class IIa (including IVDR Class B and IVDD self-test devices). The conditions are: approval obtained in at least 1 reference country, and commercial sale in that country for at least 4 months. The AMAR review time limit is approximately 45 working days. The Fast Track is equally open to renewal and amendment applications. GRZAN notes: the 4-month requirement here refers to actual sales, not to the time that has elapsed since approval — and the way this is evidenced determines success or failure.

In other words, a product that was approved in a reference country years ago but only recently began selling there does not yet qualify. Conversely, a product that reached the market promptly after approval may qualify relatively quickly. Applicants should therefore treat the 4-month period as a commercial-tracking exercise that begins the moment the first unit ships, not as a calendrical consequence of the approval date.

The scope of the route also deserves attention. The definition covers devices carrying an FDA Class II designation or an EU MDR Class IIa designation, and it reaches further into the in-vitro space: devices classified as Class B under the IVDR, as well as devices that were self-test devices under the old IVDD regime, are captured by the same clause. Companies with mixed portfolios should therefore classify each product against these labels individually, rather than assuming that a single corporate classification policy will map every product onto the same track.

2. Legal basis

The Fast Track 1 regime is set out in the fast-track guideline, anchored in the 2013 registration regulations, as summarised below.

3. Expert insights

Of the two thresholds for Fast 1, the 4-month market history is the genuinely binding constraint. A gap between the date of approval and the date of first sale is normal, but Israel requires the latter. GRZAN uses three categories of evidence in combination on its projects:

The first category is sales records: orders or invoices that can be matched to specific models, quantities and dates. The model must be exactly the model under application; for series filings, the coverage relationship between models must be explained.

The second category is logistics and customs-clearance records: delivery notes within the reference country or export customs records, used to corroborate that the product genuinely entered commercial circulation.

The third category is proof of market presence: supporting materials such as letters from local distributors, publication dates of product catalogues, and records of exhibition at academic conferences.

The second point of interest is that Fast 1 is equally open to renewals and amendments. This means that once a product enters the fast-track system, its subsequent lifecycle maintenance also benefits from the acceleration — a long-term value of the Fast Track relative to the Standard Route, not merely a faster first approval.

The third point concerns the FDA classification precedence rule (Article 10 of the Regulations): where a product holds both FDA and CE approvals, Israel processes it according to the FDA classification. For an FDA Class II product, this usually means remaining in Fast 1 rather than being pushed into Fast 2 by an EU IIb classification.

Finally, the reference-country list itself is broader than many applicants expect. The countries enumerated in Schedule 1 of the law form the base list, and within the European Union every member state is accepted as a source of an MDR CE certificate, regardless of which member state the notified body happens to sit in. This means a company does not need approvals from several distinct EU authorities to build its reference-country position — one valid CE certificate from any member state can carry the whole argument, provided the other conditions are met.

4. Practical recommendations

• Archive market-history materials monthly: from the first sale in the reference country, maintain a ledger of model, quantity and date, so evidence does not have to be reconstructed at submission time.
• State model coverage relationships clearly: for series filings, explain the correspondence between the models under application and the models already sold.
• Plan renewals and amendments together: for products that first enter through Fast 1, renewals and amendments also go through the fast track, so schedule on the basis of 45 working days rather than 120 days.
• Companies holding both certificates should first determine the classification basis: apply Article 10 to settle the applicable classification before fixing the route, to avoid mis-routing by the CE classification.

5. Verification checklist

• □ Risk class confirmed as FDA Class II or EU MDR IIa (including IVDR Class B)
• □ Reference-country approval documents valid, with consistent model and intended use
• □ Market-history evidence covers 4 months and can be matched to specific models
• □ If dual certificates are held, the applicable classification basis has been determined under Article 10
• □ Review schedule calculated on 45 working days with a deficiency-response buffer
• □ Renewal and amendment plans scheduled on the fast track

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