Israeli Medical Device Regulatory Outlook 2026-2027

1. Key takeaways

The Israeli regulatory variables for 2026-2027 concentrate on 4 lines: the possible expansion of the Second Schedule and the ministerial exemption orders (Section 2(b) of the Law, published on 14 May 2012), the pace of introduction of UDI (Unique Device Identification), the legislation of the regulatory sandbox, and the continued revision of the procedural documents. GRZAN has accordingly built a dual-track tracking mechanism: one line follows the texts of the Law and the Regulations (responsibility boundaries), and one line follows the AMAR procedural documents (operational requirements); both lines are reviewed quarterly and mapped to the affected articles among the 50 articles of this column. Because none of these variables can be resolved by a single research effort, the mechanism, not the study, is what keeps a portfolio compliant as the rules move underneath it.

2. Legal basis

The table below consolidates the instruments in force, their latest revisions, the enabling provisions for the variables discussed, and the UDI position.

3. Expert insights

Variable one: the Second Schedule and the ministerial exemption orders. Section 2(b) of the Law authorises the Minister of Health, with the approval of the Knesset health committee, to provide by order that a category of devices requires no registration, with the test being whether non-registration would harm public health. This mechanism leaves institutional space for the gradual exemption of low-risk categories, and the public-health test gives companies a predictable criterion to argue against when they believe their category qualifies. If the scope expands, the cost of market entry for the affected products will fall significantly, and companies watching this space can time their entry accordingly. The counterpart discipline is not to assume an exemption before the order is actually issued: until an order is published, the product remains within the ordinary registration regime, and planning documents should say so explicitly.

Variable two: the pace of UDI introduction. Israel has not yet published a mandatory UDI timetable. Given that Israel uses a reference-country reliance mechanism, if UDI is introduced it will most probably align with the UDI system of the EU MDR. GRZAN’s recommendation is to prepare in advance rather than wait: completing coding under the GS1 or HIBCC systems is affordable, and the same coding is usable in European submissions (practical estimate).

Variable three: legislation of the regulatory sandbox. The request for information launched in 2025 closed in April 2026. If legislation follows, autonomous medical AI will gain a controlled testing environment (article 49 of this column). The drafting details described there will decide how useful that environment is in practice, and the companies best positioned for it will be those whose AI governance documentation is already audit-ready rather than aspirational.

Variable four: continuous revision of the procedural documents. AMAR revises its procedural documents more frequently than the Law and the Regulations. This is the most certain of the variables: companies can only respond with a mechanism, not with a one-off study. A standing review cycle is the only sustainable answer to documents that change on their own schedule. In practice this means the ledger, the review calendar and the owner are defined once, and every subsequent revision is absorbed as routine work: each new REG version is read once, diffed against the previous version, and its operational impact is written into the affected articles within the same quarter. What this variable rewards is consistency rather than intensity: a short, disciplined review executed every quarter outperforms an exhaustive study performed once and then left to age.

4. Practical recommendations

• Build a dual-track tracking ledger: one line for the Law and Regulations, one line for the REG procedural documents, each recording numbers, version dates and effective dates.
• Review quarterly and map affected articles: after each review, update the affected articles of this column and refresh the verification dates in step.
• Prepare for UDI early: complete coding under GS1 or HIBCC, use it first in European submissions, and reserve the interface for possible Israeli introduction (practical estimate).
• Watch exemption developments for low-risk categories: check the Second Schedule and the ministerial exemption orders regularly and assess whether your own products are covered.

5. Verification checklist

• □ The dual-track tracking ledger is established (Law and Regulations plus REG procedural documents)
• □ The quarterly review mechanism has an assigned owner and maps affected articles
• □ The Second Schedule and ministerial exemption orders (Section 2(b)) are set as a recurring check item
• □ UDI coding planning has been assessed and shares a system with European submissions (practical estimate)
• □ Progress on sandbox legislation is on the 2026-2027 watch list
• □ The verification dates of the 50 articles of this column have been refreshed to the current period

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