Israel Fast Track 2: 60 Working Days Review

1. Key takeaways

Israel’s Fast Track 2 applies to devices classified as EU MDR Class IIb, IVDR Class C or IVDD List B. The conditions are: approvals obtained in two mutually independent reference countries, with market presence of at least 6 months in one of them. The AMAR review time limit is approximately 60 working days. Compared with Fast 1, the threshold rises from “1 country plus 4 months” to “2 countries plus 6 months”, and the review extends from 45 to 60 working days.

The additional burden is not merely quantitative. Requiring two independent regulators to have examined the product separately, and requiring a longer commercialisation record, reflects a deliberate policy choice to demand more external validation before Israel shortens its own review for higher-risk devices. Applicants should budget for both the extra evidence and the extra calendar time from the outset of project planning.

The scope of the route covers three labels: EU MDR Class IIb, IVDR Class C, and devices listed under List B of the old IVDD regime. As with Fast 1, each product in a portfolio must be checked against these labels on the basis of its current certificate, because legacy classifications do not automatically carry over into the fast-track framework after the EU regulatory transition.

2. Legal basis

The Fast Track 2 regime sits on the same fast-track guideline and the same parent regulations as Fast 1, with additional support from the EU classification rules, as summarised below.

3. Expert insights

The design of the Fast 2 threshold reflects a judgement: the higher the risk, the more independent regulatory verification is needed. The two reference-country approvals must be mutually independent — the same CE certificate paired with a national approval that relies on that CE certificate will usually not satisfy the requirement of two independent reference countries. In its assessments, GRZAN verifies whether the two approvals were issued by different authorities on the basis of their own reviews.

Two common misjudgements deserve separate attention:

Misjudgement one: treating IIa as IIb. Because some products were up-classified after MDR took effect, companies relying on outdated assumptions file products that are actually IIa under Fast 2, needlessly adding the evidence burden of 2 countries and 15 working days of extra review time. The reverse misjudgement costs more: filing an IIb product under Fast 1 leads to rejection for an insufficient number of reference countries.

Misjudgement two: reading “6 months on the market” as “sold in any reference country”. The accurate formulation is: both reference countries must hold approvals, and the market presence of at least one of them must satisfy the 6-month requirement. There is no hard requirement on the length of market presence in the second country, but its approval must be valid. In dossier terms this asymmetry matters: the sales evidence can be concentrated on the stronger market, while the second country contributes a current, unexpired approval without needing the same depth of commercial documentation.

The third point of interest is the Standard Route as an alternative. A product that does not qualify for Fast 2 is not confined to the Standard Route — if the product also holds an FDA approval, the FDA classification can be applied under Article 10 of the Regulations, which may place it in Fast 1. For companies holding both certificates, this is a legitimate optimisation path.

A final structural note concerns the validity linkage. Under Article 12(2) of the Regulations, the validity of the Israeli registration is capped by the reference country on which it relies. For Fast 2 products this makes the two foreign approvals not merely an entry condition but a standing constraint: if either approval lapses or is withdrawn, the position of the Israeli registration that rests on it must be re-examined. Renewal planning for the Israeli certificate should therefore be synchronised with the expiry calendars of both reference-country approvals, not managed in isolation.

4. Practical recommendations

• Confirm the MDR classification first: rely on the classification stated in the current CE certificate and Declaration of Conformity, not on historical assumptions.
• Verify the independence of the two approvals: confirm they were issued by different authorities on the basis of their own reviews, not one relying on the other.
• Model the classification outcome where dual certificates exist: for products holding an FDA approval, run the Article 10 determination first, since the result may downgrade the product to Fast 1.
• Schedule on 60 working days plus a deficiency buffer: for internal planning, reserve 3–4 months (practical estimate).

5. Verification checklist

• □ Risk class confirmed as MDR IIb or IVDR Class C (per the current CE certificate)
• □ Valid approvals obtained from 2 mutually independent reference countries
• □ Market history of at least one reference country covers 6 months
• □ Independence of the two approvals verified (not one relying on the other)
• □ If an FDA approval is held, the Article 10 classification-precedence determination is complete
• □ Schedule calculated on 60 working days plus a deficiency-response buffer

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