Registration Renewal Procedures under REG-2024/07 in Israel

1. Key takeaways

Renewal in Israel is governed by REG-2024/07, with channels mapped by risk classification: Class I and Class A IVDs use the declaration route; Class IIa, Class IIb and Class B/C IVDs use the fast track; Class III devices and Class D IVDs use the standard route, and must attach a post-market report. The submission deadline is set by Section 8 of the Law: no later than 4 months before expiry; once submitted on time, the registration is deemed extended until the Director General makes a decision. After the administrative automatic extension ended on 31 December 2024, this 4-month window once again became a hard constraint (article 19 of this column). Companies that miss the window lose the deemed-extension protection for reasons entirely within their own control, so calendar management around this deadline is not an administrative detail but a compliance essential.

2. Legal basis

The table below sets out the renewal procedure, the statutory deadline in the parent law, and the companion provisions on tracking, auditing and continued marketing of low-risk devices.

3. Expert insights

Three design features of the renewal stage are easily overlooked:

Feature one: the renewal channel may differ from the original registration channel. A product first registered through the standard route may, if it now meets the fast-track conditions (reference-country approval plus marketing history), use the fast track at renewal. This means renewal is an opportunity to re-optimise the channel, not merely an extension of the status quo. Reviewing eligibility at each renewal can materially shorten review times without any new evidence being generated. It also avoids the opposite trap: mechanically repeating the original route long after the product has become eligible for a faster one, which quietly costs review time at every cycle.

Feature two: the deemed extension of Section 8 of the Law is an important protection. As long as the application is submitted at least 4 months before expiry, the registration remains continuously valid until the Director General decides. This provision shifts the risk of review delay away from the company, but only on the condition of timely submission. GRZAN treats 6 months as the internal starting point (practical estimate), leaving 2 months of margin for document collection. The margin matters because post-market reports, tracking summaries and reference-country certificates all have to be assembled and checked before filing.

Feature three: Section 7 of the Regulations requires a summary of tracking and audit activities. The renewal application must include a summary of the tracking and audit activities conducted by the registration holder under Section 11 of the Law (for healthcare institutions, the summary is issued by the institution itself). This turns post-market surveillance performance into substantive renewal material: a product with no sustained tracking record will face questions at renewal, and there is no way to manufacture that record at the last minute.

The core difference among the three renewal channels lies in the post-market report: it must be prepared for Class III devices and Class D IVDs; other classifications follow the requirements of the current procedural documents. The material for this report comes from the reporting chain built under articles 41 and 42 and the batch ledger of article 39, and is genuinely a product of sustained routine work rather than a document that can be written at renewal time.

4. Practical recommendations

• Start with a 6-month lead time: the statutory window is 4 months, and the internal starting point is 6 months (practical estimate).
• Reassess the channel at renewal: check current reference-country status and marketing history to see whether an upgrade from the standard route to the fast track is possible.
• Accumulate post-market report material routinely: archive adverse events, complaints, repair records and tracking and audit summaries quarterly.
• Align with reference-country certificate renewals: delays in CE or FDA renewals compress the usable life of the Israeli registration (article 7 of this column).

5. Verification checklist

• □ The renewal start reminder is set at 6 months before expiry and submission no later than 4 months
• □ The renewal channel has been determined by risk-classification mapping (declaration / fast / standard)
• □ Whether an upgrade is possible has been reassessed (original standard route to fast track)
• □ The post-market report for Class III and Class D has been prepared
• □ The summary of tracking and audit activities under Section 11 of the Law is ready (Section 7 of the Regulations)
• □ Reference-country certificate renewal schedules are synchronised with the Israeli renewal

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