Import Permits in Israel: Periodic and One-Time Import Approvals

1. Key takeaways

Regulation 17 of the Israeli Regulations provides that, once a device has completed registration, the Director issues an import approval to the registration holder or its authorised agent. Import permits fall into two types: the periodic import permit (for continuous importation) and the one-time import permit (for specific batches, covering cases such as import not intended for sale in Israel). Completing registration does not mean import is permitted; the two are separate document tracks. Section 10 of the Law further provides that after a registration expires without renewal, or is deleted or cancelled, marketing and use may continue for a period not exceeding 2 years, but import is excluded.

• Import approval is issued separately by the Director to the registration holder or its authorised agent after registration is completed.
• Periodic import permits cover continuous importation and carry their own validity period.
• One-time import permits cover specific batches and situations where goods are not imported for sale in Israel.
• The automatic administrative extension announced in November 2023 applies to registration approvals only, not to import permits.
• After registration lapses, marketing and use may continue for up to 2 years, but new importation is not covered.
• The periodic import permit and the registration renewal run on separate calendars and must each be tracked on their own.
• Customs clearance requires the registration certificate, the import permit and, where applicable, the SII certificate to travel together as a standard pack.

2. Legal basis

The import permit regime sits in the Medical Equipment Regulations (Registration of Medical Equipment in the Register and Renewal thereof), 5773-2013, with the grace period for lapsed registrations coming from Section 10 of the parent Medical Equipment Law, 5772-2012. The table below lists the instruments, provisions and related administrative announcements. Regulatory information was verified as of October 29, 2026 against official Israeli legal databases and authoritative public sources; AMAR procedural documents are updated frequently, so the current version on the Israeli Ministry of Health website governs before formal submission.

3. Expert insights

The import permit is the step in an Israeli project where problems most often arise, and the reason lies in its independence from the registration itself. Three aspects of that independence deserve close attention.

First: a valid registration does not mean a valid import permit. The automatic administrative extension announced in November 2023 states expressly that the extension applies only to registration approvals and not to import permits. This means a product whose registration has been extended automatically may still hold an expired import permit, and the shipment can still be stopped at customs clearance.

Second: import permits must be renewed on their own schedule. The periodic import permit has its own validity period and must be renewed before it expires, or distribution will be interrupted. GRZAN therefore manages four timelines, covering the registration, the import permit, the reference-country certificate and the ISO certificate, on a single dashboard so that no expiry date is tracked in isolation.

Third: SII testing is a third gate. Active electrical products must also pass the Standards Institution of Israel route (see Part 29 of this guide). Only when all three tracks are cleared can customs clearance be completed end to end.

In day-to-day operation, the practical consequence is administrative: the four documents expire on different calendars and are renewed through different processes, so a single shared expiry view is the only reliable form of control. A distributor rarely notices an import permit expiry until a shipment is delayed, and by then the correction path is slower than a scheduled renewal would have been. This is why the timeline dashboard is not an internal convenience but the mechanism that keeps the independent tracks from drifting apart unnoticed.

The value of the one-time import permit is often underestimated. It targets specific batches and covers situations where goods are “not imported for sale in Israel”, for example participation in trade exhibitions, devices for clinical research, and samples. For companies that have not yet completed registration but need to conduct clinical evaluation or demonstration in Israel, this is a lawful channel, and it can be combined with the research-use permit under Section 4 of the Law (see Part 8 of this guide).

4. Practical recommendations

• Manage four timelines on one board. Place the registration, the import permit, the reference-country certificate and the ISO certificate side by side, and plan backwards from the earliest expiry date.
• Set a separate renewal reminder for import permits. Do not rely on the reminder mechanism for registration renewals; set an independent one for the import permit.
• Use one-time permits for exhibitions and clinical samples. Before registration is complete, cover non-sale purposes with one-time import permits.
• Standardise the customs clearance document package. Registration certificate, import permit and SII certificate (where applicable) form the standard clearance pack that travels with the goods.

5. Verification checklist

• □ A periodic import permit has been applied for after completion of registration (Regulation 17)
• □ The validity period of the import permit has been recorded, with an independent renewal reminder in place
• □ Import distributor and sub-supplier information has been declared under Regulation 3(a)(6)
• □ Whether exhibitions, samples and clinical use qualify for one-time import permits has been assessed
• □ SII certificates for active electrical products are included in the clearance document package (Part 29 of this guide)
• □ New importation has stopped within the 2-year window after registration lapses (Section 10 of the Law)

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 coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com