Non-Renewal and the Two-Year Grace Period for Devices in Israel

1. Key takeaways

Exiting the Israeli market is governed by two rules operating in parallel. Regulation 14 of the Regulations requires a registration holder who decides not to renew to notify the Director in writing before the registration expires, stating the reasons and whether sufficient alternative products exist in the market, and to publish a notice to medical institutions and the public with a copy to the Director. Section 10 of the Law then provides the buffer: after a registration expires without renewal, or is deleted or cancelled, devices may continue to be marketed, used on medical instruction, and used (excluding import) for a period of up to 2 years from the end of the registration period, unless the Director directs otherwise in writing.

• Non-renewal must be notified in writing to the Director before expiry, with reasons and an account of market alternatives.
• A public notice to medical institutions and the public must be published and copied to the Director.
• After the registration ends, marketing and use may continue for up to 2 years, but new importation is excluded.
• The 2-year window is conditional: it does not apply if the Director directs otherwise in writing.
• Record-keeping duties under Regulation 24 (3 years from batch delivery) continue after exit.
• The 2-year window runs from the end of the registration period, and the Director may override it by written direction.
• Withdrawal obligations under Regulation 13 remain relevant whenever a defect poses a risk to patients.

2. Legal basis

The exit rules combine a notification duty in the Regulations with a grace period in the parent Law, and both interact with the retention duty that outlives the registration itself. The table below sets out the instruments and provisions. 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 any formal step.

3. Expert insights

Companies leaving the Israeli market often conflate the two rules, when in fact they answer different questions.

Regulation 14 answers the question of notification. It requires active, advance and written notice to both the regulator and the users of the device. The logic behind the duty is patient continuity: the regulator needs to confirm that alternative products exist in the market, and medical institutions need to know that the device will no longer be supplied so they can arrange substitutes. An exit executed without this notification is treated as an abrupt supply cut-off, and it damages the company’s regulatory credit record in Israel.

Section 10 of the Law answers the question of inventory. It provides a window of up to 2 years during which products already in circulation may continue to be sold and used. GRZAN reads this as a stock clearance window: the company may digest the inventory it has already imported during this period, but it must not import again. Sales and use within the window are lawful, provided the Director has not directed otherwise in writing.

One connected duty is easily overlooked: the record retention obligation does not stop at exit. The 3-year period in Regulation 24 runs from each batch delivery date, so retention must continue even after the company has left the market. When closing down the Israel business, the company must designate a responsible party for custody of the records, because someone still has to be able to produce them.

Operationally, the two rules should be executed as one sequence rather than as two separate papers. The written notice under Regulation 14 starts the process while the registration is still alive; the publication reaches the users who must plan substitutes; and the window under Section 10 then covers the transition period during which remaining stock is sold and used lawfully. If the sequence is executed in the wrong order, or the publication is omitted, the exit can be lawful on paper yet disruptive in practice for the institutions still depending on the device.

The same discipline applies to the residual obligations that survive the exit. Post-market reporting duties that remain valid must be settled, the record custodian must be named, and the stock clearance plan must be reconciled against the actual deliveries recorded in the ledger. An exit that leaves any of these threads hanging tends to resurface later, when the company least expects it and when its local counterpart is no longer contracted to handle it.

4. Practical recommendations

• Make the exit decision 6 months in advance (practical estimate): leave time for notification, publication and handling of stock.
• Execute notification and publication together. Written notice to the Director plus publication to medical institutions and the public, with the publication copied to the Director.
• Stop importation and clear stock within the 2-year window. Write the window into the inventory plan and schedule no new imports.
• Designate a record custodian. After exit, records continue to be kept under Regulation 24; specify who keeps them, for how long, and how they can be accessed.

5. Verification checklist

• □ The non-renewal decision has been notified in writing to the Director, stating reasons and the availability of market alternatives (Regulation 14)
• □ A public notice has been issued to medical institutions and the public, with a copy to the Director
• □ New importation has stopped within the 2-year window (Section 10 of the Law)
• □ A stock clearance plan has been made and is being executed within the window
• □ A record custodian has been designated, with retention on the basis of batch delivery + 3 years
• □ Post-market reporting obligations that remain valid after exit have been settled

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