Route Transfer Between Declaration and Fast Track

1. Key takeaways

Israel permits route transfer (the Declaration Route guidelines were published in January 2024 and the Fast Track entered into force on 2 June 2024), covering 3 scenarios: registered products (those already holding a registration number) can move from the Standard Route to the Declaration Route by filing a renewal or amendment application, quoting the correct registration number and code at submission; renewal or amendment applications that have been filed and have received an acceptance confirmation and are awaiting review may transfer themselves into the Declaration Route; new Standard Route applications under review cannot self-transfer — the applicant must first contact the Ministry of Health by email to close the application and then refile. For legacy SKUs, this is a one-off, compliant cost-reduction channel.

The practical significance is that the reform did not strand products registered under the old regime. Companies that built portfolios before 2024 can migrate qualifying items into the faster routes without surrendering their existing registrations, provided they respect the boundary lines between the three scenarios described above.

The timing anchors are worth keeping in view when planning a transfer programme. The Declaration Route guidelines were published in January 2024, and the Fast Track came into force on 2 June 2024, so the availability of a destination route depends on which guideline governs the product in question. A transfer exercise should therefore begin by mapping each SKU to the guideline under which it would land after the move, before any filing decision is made.

2. Legal basis

Route transfer derives from the transfer clauses of the two pathway guidelines, anchored in the amendment and renewal articles of the parent regulations, as summarised below.

3. Expert insights

The practical value of route transfer is often underestimated. For legacy products registered through the Standard Route before the reform, where the risk class and reference-country conditions now meet the Declaration Route or a Fast Track, transferring delivers a triple benefit: a shorter renewal cycle, a lower documentation burden, and renewals no longer tied to the 120-day review. Because these gains recur at every renewal cycle rather than applying once, the cumulative saving across a multi-year portfolio can be substantial even where each individual transfer looks minor.

The three scenarios must be handled differently, and the distinctions must be kept clear:

Scenario one: registered products. Transfer occurs through a renewal or amendment application, with the original registration number and the correct code quoted at submission. This is the simplest case and can be combined with the annual renewal, which makes it the natural starting point for any transfer programme: the first renewal cycle after the reform is the least disruptive moment to move a qualifying legacy product onto its faster route.

Scenario two: renewal or amendment applications under review. Applications that have received an acceptance confirmation may transfer themselves into the Declaration Route. This means that if the reform took effect while a product’s renewal was pending, there is no need to withdraw and refile.

Scenario three: new Standard Route applications under review. In this case self-transfer is not allowed; the applicant must first email the Ministry of Health to close the original application and then refile. The reason for this restriction is to avoid duplicated review consuming resources; the practical consequence is that the route must be fixed before a new application is filed, because the cost of correcting a mistake afterwards is rejoining the queue from the start.

Taken together, the three scenarios reward a disciplined intake process. The scenario into which a given file falls is determined by two facts only: whether a registration number already exists, and whether an acceptance confirmation has been received on a pending renewal or amendment. Checking those two facts before touching the file takes minutes; getting them wrong means either a rejected transfer or, in the worst case, a closed application and a restart at the back of the queue.

4. Practical recommendations

• Re-assess legacy SKUs once: compare each product registered via the Standard Route before the reform against the Declaration Route and Fast Track conditions, and draw up a list of transferable items.
• Combine transfers with the annual renewal: file the transfer application of a transferable product together with its renewal, saving one interaction.
• Lock the route before filing new applications: complete the three-step determination (as set out in the three-routes article) before submission, to avoid the close-and-refile outcome of scenario three.
• Quote the registration number and code accurately: a transfer application with an incorrect number is rejected by the system.

5. Verification checklist

• □ Full list of legacy SKUs compiled with their current registration routes and risk classes
• □ Each product compared item by item against the Declaration Route and Fast Track conditions, with transferable items flagged
• □ Original registration number and correct code noted for transferable products
• □ Transfer applications scheduled together with the annual renewal or amendment
• □ Route determination completed before filing new applications, avoiding close-and-refile
• □ Renewal timelines recalculated on the new route after transfer

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