Registration Unit: Product Family and System Grouping

1. Key takeaways

Israel permits 4 submission units (under REG-2024/03, effective 1 January 2025): a single product, a product family (same risk class), a system (components designed to be used together, same class), and a group of multiple models of the same product (same class). The uniform prerequisite is that all products fall within 1 risk class. Combinations spanning classes are not accepted, and once a combination contains a product of a higher class, the whole is reviewed at that higher class. The design of the submission unit directly determines the number of registrations, the fee structure and the cost of subsequent change management.

Because these choices lock in for the life of the registrations, the grouping decision deserves the same analytical rigour as the classification and route decisions. A unit structure that looks efficient at submission can become expensive at renewal or amendment time, so the trade-offs described below should be weighed before the first dossier is ever assembled.

The four permitted unit types are not interchangeable labels but distinct constructions with different membership tests. A product family groups devices of the same risk class; a system groups components that are designed to be used together and share one class; a multi-model group covers several models of the same product at one class; and the single-product unit stands alone. Whatever the construction, the same uniform prerequisite applies: every item inside the unit must sit within one risk class. If even one member of a proposed combination carries a higher class, the entire combination is reviewed at that higher class.

2. Legal basis

The submission-unit rules come from the dossier-format guideline, anchored in the description and amendment articles of the parent regulations, as summarised below.

3. Expert insights

The submission unit is a strategy question, not a form-filling question. Three design orientations produce different consequences:

Orientation one: broad grouping (product family). The advantage is that one review covers multiple models and change management is centralised; the disadvantage is that an amendment to any one model in the family may trigger a whole-family change assessment, and the strictest requirement within the family governs the whole family. This suits consumables and accessories that are technically homogeneous and share the same intended use.

Orientation two: narrow grouping (single product or single model). The advantage is change isolation and contained risk; the disadvantage is that as the number of SKUs grows, the workload of renewals and annual declarations rises linearly. This suits high-value equipment and product lines with large technical differences. The choice between the narrow and broad orientations is therefore fundamentally a question about how the product line will evolve, not about how it looks on the day of submission.

Orientation three: system submission. This fits cases where the components must be used together (for example a main unit plus dedicated consumables plus software). The advantage is strong overall coherence; the disadvantage is that adding a component is usually treated as a substantial change and may require re-registration (see the article on changes). Companies planning a modular product roadmap should therefore be realistic about how often components will actually be added before committing a system construction, because each addition lands on the heavier end of the change spectrum.

GRZAN’s criterion is: group by change frequency, not by SKU count. Filing frequently-changing models separately from stable ones prevents high-frequency changes from dragging stable products into change assessments. This criterion is especially effective for IVDs and consumables.

The reason the criterion works is that change management, not initial registration, is where unit design pays out over time. A registration is assembled once, but amendments, renewals and annual declarations recur for as long as the product stays on the market. Grouping that ignores change behaviour therefore converts every routine product improvement into a portfolio-wide event, while grouping that anticipates change behaviour keeps routine events contained within the group that caused them. The cost difference compounds quietly over several renewal cycles, which is exactly why it goes unnoticed until the amendment backlog becomes visible.

4. Practical recommendations

• Group by change frequency: models subject to frequent changes should form their own group to avoid collateral impact.
• Run a mandatory class-consistency check: before grouping, verify the reference-country classification of every model one by one; mixing classes is prohibited.
• Reserve a component-change path for system submissions: explain at first submission the mechanism for admitting future components, reducing the probability of later re-registration decisions.
• Measure renewal workload: use the number of groups (not the number of SKUs) as the unit of workload for renewals and annual declarations.

5. Verification checklist

• □ All models within the proposed unit share the same risk class (reference-country classifications checked one by one)
• □ Grouping determined by change frequency rather than SKU count
• □ Technical homogeneity and consistency of intended use of the product family documented in writing
• □ Component list and future expansion mechanism of system submissions documented
• □ Renewal and annual-declaration workload estimated by number of groups
• □ Unit design consistent with the current format requirements of REG-2024/03

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