Regulation 10: FDA Classification Priority for Multi-Registered Devices

1. Key takeaways

Section 10 of the Israeli regulations provides a clear conflict rule: where a device is registered in more than one Recognised State and one of them is the United States, the Director shall apply the classification, registration conditions and registration period determined by the United States health authority (FDA). This rule overrides the company’s own choice. For dual-certificate companies holding both FDA and CE approvals, the Israeli review baseline is set by the FDA document – including any parts of it that are stricter or broader. Determining that baseline is therefore the first step of every submission, before any materials are assembled.

• Section 10 makes the FDA baseline prevail when the device is registered in several Recognised States including the United States.
• The FDA classification determines the Israeli route, even where it differs from the EU classification.
• Conditions attached to the FDA approval carry over into the Israeli registration conditions.
• The registration period follows the FDA baseline and the Israeli 5-year cap.
• Companies should determine the baseline first and only then organise the dossier.

2. Legal basis

The conflict rule sits within the 2013 regulations and is anchored by the registration conditions in the parent law. The elements cited in this article are listed below.

3. Expert insights

Section 10 is a conflict rule; it resolves which baseline applies when several certificates run in parallel. Its practical value is predictability: a company does not have to guess which document AMAR will rely on.

The rule produces three concrete effects for dual-certificate companies:

At the classification level, FDA and EU MDR classifications do not correspond one to one. The same product may be Class II (510(k)) at FDA but Class IIb under the MDR. Under Section 10, Israel follows the FDA Class II baseline, corresponding to fast track 1 (45 working days, requiring 4 months of marketing history), rather than proceeding as IIb through fast track 2 (60 working days, requiring approval in two states and 6 months of marketing history). This difference directly affects both timeline and evidentiary burden.

At the level of registration conditions, conditions attached to the FDA approval – such as specific labelling requirements or post-market study commitments – carry over into the Israeli registration conditions. Restrictions imposed in the reference state do not disappear because the device enters Israel.

At the level of period, the registration period is set by the FDA baseline. Since a 510(k) itself has no expiry date, the Israeli registration period for such products is governed by Israel’s own rule (a cap of 5 years); where a CE certificate carries a definite expiry date, Section 12(2) applies and the Israeli period may not exceed the reference-state validity.

GRZAN’s advice is that dual-certificate companies should not assume whichever is faster will be used. First determine the baseline under Section 10, then identify the route and the evidentiary requirements under that baseline, and only then organise the materials.

The same logic applies inside the dossier: every field that AMAR will compare – models, intended use, manufacturer details, certificate validity – should be aligned to the FDA document, since that is the document against which the consistency check is run.

It is also worth noting how the three effects interact. The classification determines the route; the route determines the timeline and the marketing-history evidence; the attached conditions determine what the post-registration obligations look like; and the period rule determines when the renewal cycle must begin. A company that discovers late in preparation that the FDA baseline pulls the dossier onto a different route – with a different marketing-history threshold and a different set of conditions – will have to rework its schedule, its evidence files and its labelling in one motion. Determining the baseline at the very start, before any dossier assembly, is therefore the single most consequential scheduling decision in a dual-certificate submission.

4. Practical recommendations

• Maintain a baseline comparison table: place the FDA and CE classifications, intended-use wording and additional conditions side by side, item by item, and flag every difference.
• Rehearse the route on the FDA baseline: derive the Israeli route and timeline from the FDA classification, then match it against the actual reference-country marketing history.
• Explain differences proactively: where the intended-use wording of the two documents differs, attach a letter of explanation at submission so the dossier is not treated as inconsistent.
• Calculate the period on both tracks: compute the scenario “FDA has no expiry → Israeli cap applies” and the scenario “CE has an expiry date → take the shorter”, and schedule on the conservative value.

5. Verification checklist

• □ All reference-country approval documents have been listed and marked for whether the United States is included
• □ The classification baseline applicable in Israel has been determined under Section 10
• □ Differences between the FDA and CE documents in intended use, models and additional conditions have been compared item by item and archived
• □ The route (declaration / Fast 1 / Fast 2 / standard) and timeline have been derived from the chosen baseline
• □ The registration-period calculation has considered both the reference-state validity and the Israeli cap
• □ A letter of explanation (if any) has been submitted with the dossier

Regulatory information verified as of 29 October 2026. All law names, numbers, publication dates and article numbers cited in this article were checked on that date against the official Israeli legal database and authoritative public sources; AMAR procedural documents are updated frequently, so before any formal submission please rely on the current version published on the Ministry of Health website.

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 Ministry of Health (MOH) registrations under the Medical Devices Law 5772-2012, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com