Administrative Extension of Registrations Ended in 2024

1. Key takeaways

In November 2023 the Israeli Ministry of Health announced that registration approvals with validity dates falling between 1 December 2022 and 30 December 2024 were automatically extended to 31 December 2024. The extension applied only to registration approvals, not to import permits, and did not apply in two situations: where the device underwent a change requiring an amendment submission, or where the Ministry had ordered cancellation or suspension of the registration. The extension mechanism ended on 31 December 2024; from 2025 the ordinary renewal rules apply in full — the submission of renewal applications at least 4 months before expiry, required by Article 8 of the Law, is once again a hard constraint.

The end of the grace period therefore changes behaviour, not just law. Habits formed during 2022–2024, when lapses were tolerated, must now be replaced by calendar-driven renewal management, because from 2025 a missed window means an expired registration rather than a merely delayed one.

The mechanics of the original extension are worth recalling precisely, because they determine which certificates were touched by it. The measure applied to registration approvals — and to renewal approvals — whose validity dates fell inside the window between 1 December 2022 and 30 December 2024, lifting each of them to a common end date of 31 December 2024. Anything outside that window, and any certificate other than a registration or renewal approval, was left untouched by the notice.

2. Legal basis

The extension derived from a Ministry of Health notice, anchored in the renewal article of the parent law, with a new renewal procedure guideline taking effect afterwards, as summarised below.

3. Expert insights

The administrative extension was a transitional safety net, designed to prevent registration gaps during the EU MDR transition and global supply-chain turbulence. Its termination brings three practical changes:

Change one: the buffer is gone. Between 2022 and 2024, a registration remained valid even if the renewal window was missed. From 2025 that safety net has disappeared: missing the window means expiry, and the cost of restoring an expired registration far exceeds that of renewing — it often requires the full registration process to be run again. The asymmetry between the small effort of filing on time and the large cost of re-registration is the single strongest argument for calendar-driven renewal governance.

Change two: import permits were never extended. Many companies assumed the extension covered all certificates. In reality, import permits were always governed by their own validity periods; a registration that is valid but paired with an expired import permit still cannot clear customs. GRZAN recommends managing the registration and the import permit as two independent timelines, each with its own owner, reminder cycle and renewal evidence, so that one expiring never silently disables the other.

Change three: changes broke the extension. If a device underwent a change requiring an amendment application, the automatic extension did not apply. This means that companies that modified products during the extension period may have registrations that were already outside the protection of the extension, and each case must be checked individually.

Underneath all three changes sits one structural feature of the parent law that remains in force: under Article 8 of the Medical Equipment Law, once a renewal application has been submitted before expiry, the registration is deemed extended until the Director decides. The extension notice was an extraordinary measure layered on top of this rule, not a replacement for it. With the notice gone, the ordinary sequence — file early, stay deemed-extended, receive the renewal decision — is once again the only protection a registration holder has, and it works only for those who file inside the statutory window.

4. Practical recommendations

• Build a three-certificate timeline board: one line each for registration approvals, import permits and reference-country certificates, scheduled backwards from the earliest expiry date.
• Start with a 6-month lead: the statutory window is 4 months; GRZAN recommends starting preparations 6 months ahead (practical estimate) to leave room for material collection and internal approvals.
• Check historical extension applicability case by case: for registrations where product changes occurred between 2022 and 2024, confirm whether they were still within the extension’s protection.
• Determine the renewal route under REG-2024/07: the renewal route may differ from the original registration route (see the article on renewals).

5. Verification checklist

• □ Expiry dates of all registration certificates logged and sorted by date
• □ Import-permit expiry dates logged separately (not covered by the extension)
• □ Whether changes requiring amendments occurred between 2022 and 2024 checked case by case
• □ Renewal start reminder set for 6 months before expiry
• □ Renewal applications filed no later than 4 months before expiry
• □ Renewal route determined under REG-2024/07 (Declaration Route / Fast Track / Standard Route)

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

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 MOH registration applications across risk classes, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com