Israel Standard Route: 120 Calendar Days

1. Key takeaways

Israel’s Standard Route applies to Class III devices, IVDR Class D devices, mid-risk devices that do not meet the Fast Track conditions, and products that are manufactured only in Israel and not registered in any reference country. Article 5 of the Regulations provides that the Director shall notify the decision within 120 days of submission of the application, and the registration certificate shall be issued within 3 working days of approval. AMAR’s published official target is likewise 120 calendar days; in practice the process usually takes 4–6 months (practical estimate). The key rule: time spent responding to deficiency requests does not count towards that period.

That last rule reshapes the whole planning picture. Because the statutory clock pauses whenever the authority asks for additional material, the total calendar duration of a Standard Route case is not fixed at 120 days but moves with the completeness of the initial dossier and the speed of each deficiency response. Projects that submit complete files on the first attempt can approach the official target; projects with thin dossiers should expect the longer end of the practical range.

The scope of the route is correspondingly broad. It captures the highest-risk devices — Class III and IVDR Class D — but it also catches two less obvious groups: mid-risk devices whose reference-country position does not satisfy a fast track, and products manufactured only in Israel with no registration anywhere abroad. The common denominator across all of these groups is that the authority performs a full substantive review of the technical file itself, rather than leaning on another regulator’s decision.

2. Legal basis

The Standard Route is anchored directly in the 2013 registration regulations and their parent law, as summarised below.

3. Expert insights

The exclusion of deficiency-response time is the key to understanding Standard Route timelines. The 120 days of Article 5 count only the Director’s review time; the time consumed by the company in supplementing materials is excluded. The actual duration therefore equals 120 days of review plus the waiting time across one or more deficiency rounds. GRZAN’s working assumption is that each deficiency round typically adds 1–2 months, and it is not unusual for projects with incomplete dossiers to go through 2–3 rounds. On a multi-round case, the deficiency time alone can rival the statutory review period itself, which is why dossier completeness is treated here as a scheduling variable rather than a quality nicety.

This yields a cost conclusion: under the Standard Route, the value of submitting right the first time exceeds the value of rapid follow-up. Resources invested in a completeness self-check before submission pay back far more than chasing the file after it has been lodged.

The second point of interest is the sample requirement of Article 4. The Director may require the applicant to provide samples of the equipment, which has a material impact on the cost and logistics of high-value or large equipment. Project budgets should reserve room for sample preparation.

The third point is the special case of products manufactured in Israel but not registered in any reference country. Israel places such products on the Standard Route because there is no external review to rely on. For multinational companies with production or assembly operations inside Israel, this clause is easily overlooked — localising production does not exempt a product from the full technical review.

Two further procedural details complete the picture. Article 16 of the Regulations provides that a duplicate certificate is issued within 7 working days, which matters operationally when distributors or importers need certified copies in a hurry. And refusals under Article 5 must state written reasons, which gives the applicant a defined basis for deciding what to fix before deciding whether to refile. Neither detail shortens the review, but both shape how the aftermath of a case is managed.

4. Practical recommendations

• Model the timeline as 120 days plus N deficiency rounds: base internal scheduling on 4–6 months and leave headroom in external commitments.
• Give priority to first-time completeness: before submission, run a double completeness self-check against REG-2024/03 and Article 3(a) of the Regulations.
• Include sample costs in the budget: for high-value or large equipment, confirm early whether samples must be provided and reserve logistics time.
• Identify local-production cases early: products manufactured in Israel without a reference-country registration should be prepared for the full Standard Route technical dossier from the start.

5. Verification checklist

• □ Confirmed the product is Class III, IVDR Class D, lacks a reference-country approval, or is locally manufactured in Israel without foreign registration
• □ Technical documentation aligned in depth with the requirements of REG-2024/03 (risk management, clinical evaluation, performance and safety testing)
• □ Completeness self-check against the 13 elements of Article 3(a) of the Regulations completed
• □ Need for samples assessed (Article 4 of the Regulations) with budget reserved
• □ Schedule modelled as 120-day review plus deficiency rounds, with a practical baseline of 4–6 months
• □ Deficiency-response mechanism established (internal turnaround within 10 working days, practical estimate)

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