Israel Declaration Route: Registration Within 48 Hours

1. Key takeaways

Israel’s Declaration Route went live in September 2023, with formal guidelines published in January 2024. It applies to Class I devices (including sterile, measuring, surgical and reusable types) and IVD Class A laboratory equipment, on the condition that the product is already registered and marketed in a reference country. The system issues a technical confirmation email within 4 hours, and the registration confirmation arrives no later than 48 hours. Dossiers are organised and submitted according to 7 folders, and no government fees are charged for new registrations, amendments or renewals. The submission window for the annual renewal declaration runs from 1 October to 31 December of each year.

Taken together, these features make the Declaration Route the fastest and least burdensome entry point into the Israeli market for low-risk products that already hold approvals abroad. Its speed, however, rests entirely on the applicant preparing the dossier exactly as prescribed, because the automated confirmation process leaves little room for informal or incomplete submissions.

2. Legal basis

The route rests on a dedicated AMAR guideline supported by the parent regulations, as summarised below.

3. Expert insights

The 7-folder structure of the Declaration Route is a hard requirement, and the numbering must be preserved exactly:

1. Declaration letter (choosing the corresponding declaration template according to “individual or legal entity” and “new registration, renewal or amendment”)
2. Regulatory approvals (with four sub-folders: FDA 510(k) or registration listing, CE certificate, Declaration of Conformity, and approvals from other countries)
3. Importer documents (ISO 9001 or GMP certificate of the IRH or the importer)
4. Manufacturer documents (QMS certificate such as ISO 13485)
5. Technical documentation (not mandatory)
6. Catalogue (catalogue, instructions for use, labels)
7. Cover letter (not mandatory)

Item 5 — technical documentation being non-mandatory — is the clause most easily misread. GRZAN’s interpretation is that not submitting the file does not mean the file need not exist. Although Class I manufacturers are not required to provide an ISO 13485 certificate, they must submit a declaration of conformity with the requirements of that standard; and although the technical documentation is not filed with the application, the registration holder must still keep the complete supporting documentation ready for post-market spot checks. In effect, the Declaration Route moves the burden of proof from “the moment of submission” to “the moment of inspection”.

The second point of interest is the content of the eight declarations. The declaration letter must state: the truthfulness of the materials and the commitment to import and sell the product in Israel; that the product is identical to the product approved in the reference country and is sold there; that the product and manufacturer comply with all regulatory and quality requirements of the reference country; that the holder will report changes in the materials to the Ministry of Health; that the holder possesses all supporting documentation; that materials will be transferred on request; that product changes will be reported; and that adverse events and recalls in Israel or worldwide will be reported. These eight items constitute a continuing obligations checklist for the IRH, not a one-time signature.

The practical weight of this list should not be missed. Because the declarations survive beyond the 48-hour confirmation, the holder’s obligations continue for as long as the registration does. A company that treats the declaration as a formality at submission, and then fails to report a later change or recall, has not merely filed an incomplete document once — it is in continuing breach of the very instrument on which its registration rests. Governance inside the company should therefore treat these eight commitments as inputs to the post-market compliance system, with named owners and reporting procedures behind each one.

4. Practical recommendations

• Organise the ZIP file strictly by folder number: do not submit extra folders and do not alter the numbering — files that do not match the prescribed format are rejected outright by the system.
• Build a standby technical documentation package: even though it is not submitted, prepare and retain it at the depth of a Standard Route dossier so it can be produced within 48 hours if a spot check occurs.
• Batch the annual declarations: consolidate the renewals of all Class I devices and Class A IVDs and submit them in one action inside the 1 October window.
• Run renewals and amendments through the same route: renewal materials resemble those for a new registration; for amendments only the relevant documents need to be filed, but this applies to non-substantial changes only.

5. Verification checklist

• □ Classification confirmed as Class I or IVD Class A, and the product is registered and marketed in a reference country
• □ ZIP file organised according to the 7-folder structure, with numbering matching the guideline
• □ Declaration letter uses the correct template for “individual or legal entity” and “new registration, renewal or amendment”
• □ Reference-country approvals, ISO 9001 (IRH or importer) and ISO 13485 (manufacturer) are all in place
• □ Standby technical documentation package established and quickly retrievable
• □ Annual declaration reminder set for 1 October

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