REG-2024/03, /07 and /08 Procedures Effective from 2025 in Israel

1. Key takeaways

From 1 January 2025, three Israeli procedural documents took effect simultaneously: REG-2024/03 (registration procedure for the register — details and formats of submission documents), REG-2024/07 (registration renewal procedure) and REG-2024/08 (registration change procedure). The accompanying registrant declaration templates (for the standard route and the fast track, covering new registrations, renewals and changes) and the wording of the Global Sales Details letter were updated at the same time. This set of documents converts what previously depended on communication experience into written procedure, and the direct consequence is that the price of non-compliant formatting has escalated from a request for correction to outright rejection. Companies accustomed to resolving format questions through informal exchanges with reviewers should treat that approach as no longer available, and invest instead in pre-submission verification against the written requirements. The companies that adapt fastest to this shift are those that already operate a submission checklist culture elsewhere, because the change is procedural rather than substantive: no new technical evidence is demanded, only that what is submitted matches, item for item, what the procedure says a submission contains.

2. Legal basis

The table below lists the three procedural documents, their effective date, the accompanying templates, and the rejection provisions of the parent regulations.

3. Expert insights

The significance of this set of documents lies not in creating new obligations but in writing existing obligations down and standardising discretion. Three consequences deserve the attention of companies:

Consequence one: format compliance has become a threshold requirement. Section 11 of the Regulations already provided that incomplete applications could be rejected directly, but the judgement of completeness previously depended partly on communication. Once the procedural documents took effect, the standard became written: document naming, folder structure and declaration template versions all have explicit requirements. System-level automated validation now rejects submissions that do not conform to the format without a human reviewer ever looking at the content. The practical implication is that no reviewer will read past a naming error to find an otherwise complete dossier: the gate closes before the substance is reached.

Consequence two: submission content has become checklist-based. REG-2024/03 lists the submission documents item by item, so companies can complete self-checking at the preparation stage instead of waiting for a correction notice. This in fact reduces information asymmetry, which is good news for well-prepared companies: the requirements are no longer discoverable only through repeated interactions. It also levels the field between large and small applicants, since the same written list applies to everyone and no informal advantage substitutes for a complete file.

Consequence three: renewal and change channels have become explicit. REG-2024/07 and REG-2024/08 respectively give the channel mappings for renewal and changes, so companies can calculate timelines in advance instead of asking case by case. Planning across a product portfolio becomes possible for the first time on a purely documentary basis, which matters most for companies running parallel submissions of several products, where a single misjudged channel can cascade into a quarter of avoidable delay.

GRZAN assesses this set of documents as the watershed at which the Israeli registration system moved from being experience-driven to being procedure-driven. For companies, the response is direct: turn the current REG documents into an internal checklist and tick off every item before each submission, and review that checklist each time AMAR republishes a document, so that no rejection is ever caused by an avoidable format defect. The checklist should be versioned alongside the REG documents themselves, so that when AMAR issues a new revision the internal control document is updated in the same cycle rather than lagging behind by one rejected submission.

4. Practical recommendations

• Build a ledger of the REG documents: record numbers, version dates and applicable subjects, and review it quarterly.
• Use current templates, not historical ones: the declaration templates and the Global Sales Details letter have updated versions, and submissions on old versions will be rejected.
• Run a format self-check before submission: check file names, folder structure, and signature and stamp positions item by item.
• Make the Global Sales Details letter a standard asset: its content covers sales status in multiple countries, so it can be compiled once and reused in many submissions.

5. Verification checklist

• □ Current versions of REG-2024/03, /07 and /08 have been obtained and registered (effective 2025-01-01)
• □ The latest registrant declaration templates are in use (standard / fast track by new registration / renewal / change)
• □ The Global Sales Details letter has been prepared using the updated wording
• □ File names and folder structure have been checked against the procedural documents
• □ A pre-submission format self-check form has been established and is being executed
• □ A contingency plan for rejection as incomplete has been assessed (1 month cooling-off period, Section 11 of the Regulations)

Regulatory information verified as of 29 October 2026. The regulation 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 procedural documents are updated frequently, so before any formal submission please rely on the current version published on the website of the Israeli Ministry of Health.

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 adverse event reporting and recall coordination with the MOH, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com