Application Dossier Elements under Regulation 3

1. Key takeaways

Article 3(a) of the Israeli Medical Equipment Regulations, 5773-2013, fixes the statutory elements of a registration application at 13 categories, and the application must be submitted in electronic format. Within that list, item (8) — the foreign registration certificate together with evidence of actual sales in the country of registration — is the element most frequently missing from dossiers prepared by Chinese manufacturers, while items (2) and (3) — the storage and transportation conditions certificate and the manufacturing conditions certificate — are the ones most often mistaken for documents that an ISO certificate can simply replace. If any single element is missing, Article 11 provides for the application to be rejected outright without a stated reason, and the applicant then enters a 1-month cooling-off period before a fresh application can be considered.

• The 13 elements are exhaustive: the absence of any one of them is itself a ground for rejection under Article 11, with no explanation owed to the applicant.
• Item (8), the foreign registration certificate plus evidence of actual market sales, is the single most common gap in Chinese-origin dossiers.
• The storage and transportation conditions certificate (item 2) and the manufacturing conditions certificate (item 3) cannot be satisfied by ISO certificates alone.
• Article 3(b)–(e) adds four special application scenarios, each with its own additional documentation set, so the applicable scenario must be identified before drafting begins.

2. Legal basis

The requirements summarised above derive from the following instruments. The table records the regulation, its number and publication date, the operative provisions, and the companion AMAR procedure document that itemises the declaration dossier.

3. Expert insights

Of the 13 elements, the three that follow group them by how difficult they are to obtain, and each group calls for a different preparation strategy.

First tier: information the company already owns (items 1, 4, 5, 6 and 9). This covers the Israeli company information with its business licence number and expiry date; the full Hebrew and English names of the equipment, its model, physical description, and its technical, medical and functional characteristics; the indications and intended use; the names of the importing distributor and sub-suppliers; and the manner in which support and maintenance services are provided and by whom. This tier is comparatively easy to prepare, but two points deserve care: the Hebrew name requires professional translation, and it must be consistent with the labeling. A name agreed late in the project tends to drift between documents, and any inconsistency is visible to the reviewer at a glance.

Second tier: third-party certificates (items 2, 3, 7, 8 and 13). This covers the storage and transportation conditions certificate (compliance with Article 20); manufacturer and production site information together with the manufacturing conditions certificate (compliance with Article 19); a statement of whether the device contains preparations, chemical substances, poisons or biological substances, and whether it emits ionising or non-ionising radiation; the foreign registration certificate with evidence of actual sales; and the training documents required when the application is submitted by a qualified professional. The difficulty in this tier is that the scope of each certificate must cover the site actually intended for the application, not merely the company as a legal entity. A group-level certificate that names the parent company but not the production plant will not discharge the obligation.

Third tier: declarations and markings (items 10, 11 and 12). This covers the labels, markings and proposed instructions for use (where the Director so requires); proof of payment of the application fee under section 22 of the Law; and the declaration by the applicant and the manufacturer that complete and reliable information is provided. Although item 11 is drafted as a fee-payment clause, government fees have no longer been collected since 15 August 2022, so in practice this item is handled under the current practical estimate.

A GRZAN note: Article 3(b)–(e) separately establishes four special scenarios — registration in a reference country, manufacture in Israel without registration in a reference country, substantially equivalent devices, and devices supplied only to medical institutions. Each scenario carries a different set of additional documents, so the applicable scenario must be determined before the dossier is assembled, because it changes both the content and the order of the file.

4. Practical recommendations

• Close the list item by item with a checklist. Turn the 13 elements into a checklist, and record for each element the person responsible for obtaining it and its current status, so that gaps are visible before submission rather than after rejection.
• Fix the Hebrew name first. The Hebrew translation of the device name must be identical in the label, the instructions for use and the Register, so settle the translation before translating any other material.
• Verify certificate scope. The ISO 13485 certificate and the manufacturing conditions certificate must cover the actual production site, including any outsourced sterilisation provider.
• Prepare the evidence of actual sales early. Combine reference-country sales records, customs declarations and distributor letters into a single evidence package, because item (8) is the most frequent gap and the 1-month cooling-off period after rejection makes second attempts expensive.

5. Verification checklist

• □ All 13 elements have been closed out item by item, with none missing
• □ Israeli company information includes the business licence number and its expiry date (item 1)
• □ Storage and transportation conditions certificate and manufacturing conditions certificate are in place and cover the actual sites (items 2 and 3)
• □ Hebrew and English device names and model designations are fixed and match the labeling (item 4)
• □ Foreign registration certificate and evidence of actual sales are complete (item 8)
• □ The applicable scenario has been determined: reference country / Israeli manufacture / substantially equivalent / medical institutions only (Article 3(b)–(e))

Regulatory information verified as of 29 October 2026. The regulation names, numbers, publication dates and provisions cited in this article were checked against the official Israeli legal databases and authoritative public sources on that date; AMAR procedural documents are updated frequently, so before any formal submission the current version on the Ministry of Health website prevails.

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 prepares MOH-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com