Registration Cancellation, Market Withdrawal and Device Deletion in Israel

1. Key takeaways

Cancellation of registration in Israel is governed by Section 9 of the Law, and there are three grounds: the conditions for registration in Section 6(a) are no longer satisfied; the reference-country registration has been deleted, or the device is found to be harmful, ineffective or of poor quality; or the registration holder violates a Section 7(a) condition or fails to comply with a Section 11 direction. The procedural safeguard is that before the Director General makes a decision, the registration holder must be given an opportunity to be heard, and healthcare institutions and the public must be updated. Withdrawal is governed by Section 13 of the Regulations: where a device does not conform to the registration requirements or has a defect that may harm patients, its sale must be stopped immediately and the device withdrawn as directed by the Director General. Understanding how these provisions interact matters because the sequence a company chooses, voluntary withdrawal versus contested cancellation, largely determines the final regulatory outcome.

2. Legal basis

The table below consolidates the cancellation grounds, the procedural safeguard and the post-cancellation marketing window under Israeli law.

3. Expert insights

Ground 9(a)(2) is the one most easily triggered by Chinese companies: deletion of the reference-country registration. Because Israel relies on reference-country approvals, once a CE certificate is suspended or revoked by a notified body, or an FDA approval is withdrawn, the Israeli registration loses its basis. This means that compliance fluctuations on the European or American side transmit directly to Israel: companies must build status monitoring of reference-country certificates into their routine early-warning arrangements, so that a suspension in Europe is known in Tel Aviv within hours rather than weeks. The monitoring should cover not only the certificate itself but also public notices from notified bodies and regulators, since a suspension is often signalled before it is formally communicated to the manufacturer.

The second point of interest is the opportunity to be heard under Section 9(b). This is a procedural safeguard and also the company’s only window for defence. GRZAN applies three principles when handling it: respond quickly (the response period is usually short), use hard evidence (answer with technical data rather than explanatory narrative), and remediate in parallel (submit a corrective action plan together with the response, demonstrating that compliance has been restored). A submission built on these three principles converts the hearing from a formality into a genuine chance to keep the registration. Companies should also decide in advance who signs the response and who speaks to the Director General’s office, so that the short window is not consumed by internal approval loops while the deadline runs.

The third point of interest is the sequence between withdrawal and cancellation. Withdrawal under Section 13 of the Regulations is the company’s proactive duty (stop sales as soon as a defect is found), while cancellation under Section 9 of the Law is the regulator’s subsequent action. Proactive withdrawal combined with remediation can often prevent the matter from ever reaching cancellation; concealment or delay, by contrast, will simultaneously trigger the Section 9(a)(3) ground of failure to comply with Section 11 directions. In other words, the same defect can end in a managed withdrawal or in a cancellation record, depending entirely on how quickly and transparently the company moves. This is why the withdrawal trigger belongs in the quality system rather than in a crisis playbook drafted after an event: the decision window is short, and the documentation trail, from defect identification to the notice to the Director General, is what distinguishes a proactive holder from a negligent one in the regulator’s eyes.

4. Practical recommendations

• Set up early warning on reference-country certificate status: any change to a CE certificate or FDA approval is reported to the IRH within 24 hours (practical estimate).
• Prepare hearing submission templates: technical data, corrective action plans and third-party verification reports, three categories of material prepared in advance.
• Prefer proactive withdrawal over passive cancellation: stop sales immediately upon finding a defect and report to the Director General, to prevent escalation.
• Use the 2-year window after cancellation: after a registration is cancelled, marketing and use may continue for no more than 2 years (excluding import), which can be used for inventory handling and customer transition. Planning for this window in advance, rather than negotiating it under pressure after cancellation, protects both patients and distributors and gives the company a controlled endpoint instead of an abrupt one.

5. Verification checklist

• □ Status monitoring and early warning for reference-country certificates is established (CE or FDA changes reported to the IRH immediately)
• □ Hearing submission templates are prepared (technical data, corrective action plan, third-party verification)
• □ Trigger conditions and the process for proactive withdrawal are written into quality system documentation (Section 13)
• □ The process for the opportunity to be heard under Section 9(b) and its response deadlines are confirmed
• □ The 2-year inventory and customer transition plan after cancellation is prepared in advance (Section 10 of the Law)
• □ The notification path to healthcare institutions and the public is clearly defined

Regulatory information verified as of 29 October 2026. The regulation 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 procedural documents are updated frequently, so before any formal submission please rely on the current version published on the website of the Israeli Ministry of Health.

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 adverse event reporting and recall coordination with the MOH, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com