Certificate of Free Sale and Apostille Authentication

1. Key takeaways

Article 18 of the Israeli Regulations (Regulations 5773-2013, published 12 June 2013) provides that the Director may, upon request, issue a certificate confirming that a specific device has been registered in Israel and may be marketed in Israel — this is the export direction of the certificate of free sale (CFS). The reverse, import direction, is this: foreign manufacturers must provide a certificate of free sale (CFS/CFG) from the country of origin as supporting material additional to reference-country approvals, and in some cases it must pass Apostille certification or authentication by an Israeli embassy or consulate. China has been subject to the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (the Apostille Convention) since 7 November 2023, but whether an Apostille can fully replace consular authentication must still be confirmed against the current position of the Israeli competent authorities (practical estimate).

• The CFS has two directions in Israeli projects, and companies usually watch only one of them.
• On the import direction, the CFS model list must correspond one to one with the models under application; generic family-level wording is routinely returned.
• On the export direction, an Israeli CFS obtained after registration can support entries into other markets — a register-once, reuse-everywhere asset.
• Since China joined the Apostille Convention, documents only need an apostille for circulation among member states, but Israeli acceptance must be verified per document type.

2. Legal basis

The table below records the regulation, the operative provisions, the international convention and the practical estimate on apostille acceptance.

3. Expert insights

The CFS has two directions in Israeli projects, and companies tend to focus on only one of them, leaving the other unused.

The import direction (entry material). A foreign CFS serves to corroborate that the product is lawfully marketed in its country of origin. For products that already hold approvals in reference countries, the CFS is usually supporting material rather than core material; but where the reference-country approval documents do not cover everything — for example, where the model ranges differ — the CFS can reinforce the file. GRZAN’s practical estimate here is blunt: the model list on the CFS must correspond one to one with the models under application, and generalized wording such as a whole series designation is routinely returned for correction.

The export direction (an international expansion asset). The direction granted by Article 18 is often overlooked, yet its value may be higher: once the product is registered in Israel, an Israeli CFS can be applied for and used in other markets that recognise Israeli approvals or that require a certificate of free sale from the country of origin or any reference country. This is an asset-building logic of register once, reuse in many places, particularly suited to companies positioning Israel as their Middle East regional hub. The certificate should be treated as a planned deliverable of the registration project from the outset, not an afterthought added after approval.

On the method of authentication, after China acceded to the Apostille Convention, public documents issued in China circulate among member states without consular authentication, requiring only an apostille certificate. This has significantly shortened the authentication cycle for the CFS. However, the acceptance position of the Israeli competent authorities differs across document types (practical estimate), so GRZAN recommends confirming the current requirement with AMAR through the IRH before filing, to avoid the material being returned because the authentication method does not match. The chain from notarisation through authentication should also be kept complete, since a missing link in the chain defeats the purpose of the apostille itself.

4. Practical recommendations

• Make the CFS model list precise. List the models individually so that the list corresponds exactly to the models under application.
• Confirm the authentication method before arranging it. Confirm through the IRH with AMAR whether an apostille is accepted, and only then decide between the apostille and consular authentication.
• Add the Israeli CFS to the international expansion asset list. Apply for it proactively once registration is complete, building materials in reserve for other markets.
• Manage validity periods. The CFS usually carries its own validity period; enter it into the expiry-date board synchronised with reference-country certificates and the AMAR registration.

5. Verification checklist

• □ The country-of-origin CFS has been obtained, with its model list corresponding one to one to the models under application
• □ Whether the apostille is accepted has been confirmed through the IRH (practical estimate)
• □ Authentication (apostille or consular) is complete, and the document chain is intact (notarisation to authentication)
• □ The CFS validity period has been entered into the expiry-date board
• □ After completing AMAR registration, application for an Israeli CFS has been planned (Article 18 of the Regulations)
• □ The reuse relationship between the CFS and application materials for other markets has been mapped

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