SII Import Reform 2025: EU Compliance Replacing Israeli Local Testing

1. Key takeaways

From January 1, 2025, the Israel Standards Institution (SII) has been rolling out an import reform: products that conform to European Union legislation, or that are already lawfully sold within the EU, may be exempted from the testing normally required under the standard route, with a declaration of conformity replacing the test certificate. The mechanism is implemented by amending the application of the 1953 Standards Law product by product, and it is not restricted by place of manufacture: products made in China that carry a valid CE mark can equally benefit. The reform proceeds in phases by product category and is to be completed by 2028. Whether medical devices have already been brought within the current category list must be verified category by category (practical estimate).

• EU conformity or lawful EU sale can replace SII testing with a declaration of conformity for covered categories.
• The mechanism is not tied to where the product is manufactured; a valid CE mark is what matters.
• Implementation amends the application of the Standards Law, 5713-1953, product by product.
• The reform is phased by category and scheduled for completion by 2028.
• Food, motor vehicles and fire safety equipment (with an exception for specific firefighting equipment) are outside the route.
• SII exemption and AMAR registration remain two independent tracks; neither replaces the other.
• The judgment criterion is EU conformity or lawful EU sale, not the country of manufacture.

2. Legal basis

The reform is not a single device-specific statute but a rolling mechanism that changes which standards apply at the border. Its legal vehicle and timetable are set out below. Regulatory information was verified as of October 29, 2026 against official Israeli legal databases and authoritative public sources; the applicability status of any category must be confirmed against SII’s current announcements before reliance.

3. Expert insights

The direction of the reform is to replace national standards with international ones: in substance, Israel is aligning its standards system with the EU’s in order to reduce the compliance cost of entry. Three characteristics are worth grasping.

Characteristic one: no restriction by place of manufacture. The test is whether the product conforms to EU legislation or is lawfully sold in the EU; the manufacturing location is irrelevant. This is a substantive benefit for Chinese manufacturers, because products holding a valid CE mark can take this route without repeating local Israeli testing.

Characteristic two: a declaration of conformity replaces the test certificate. Exemption from testing does not mean exemption from paperwork. Companies must still submit a declaration of conformity, whose content and format must meet SII requirements, and the declaration must be traceable to the technical evidence that supports it.

Characteristic three: phased rollout with a dynamically expanding list. The reform converts categories in batches, and the list of EU legislation that has been switched over continues to grow. This means the same product may not qualify in 2025 yet qualify in 2027. Verifying category by category, at the current point in time, is the only reliable method.

GRZAN adds one caution: the SII reform and AMAR registration are two independent tracks. Even if a product is exempt from testing on the SII side, registration and the import permit on the AMAR side must still be completed. The fact that a product is acceptable in the EU does not allow the device registration to be bypassed.

For a manufacturer holding a CE mark, the route begins with a scope question rather than a testing question: which Israeli category the product falls into, and whether that category has already been switched over. Once the category is confirmed as covered, the deliverable shifts to documentation: a declaration of conformity in the form SII expects, backed by the CE certificate and the underlying technical evidence. Where the category is not yet covered, the conventional testing path remains the fallback, which is why keeping CB certificates and EMC reports current belongs in the same plan rather than in a separate exercise. And because a product outside the list today may be covered in a later phase, the scope question is worth asking again periodically rather than only once.

4. Practical recommendations

• Verify the applicability status category by category. Ask SII or the Israeli Registration Holder (IRH) whether the product’s category has been brought within the reform list, and keep the written reply.
• Prepare a declaration of conformity that meets SII requirements. The declaration must be traceable to technical evidence (CE certificate, declaration of conformity, test reports).
• Schedule the two tracks in parallel. Advance the SII side and the AMAR side at the same time; do not skip AMAR registration because of a testing exemption.
• Review the category list quarterly. The reform list keeps expanding, so a regular review may uncover new testing-exemption opportunities.

5. Verification checklist

• □ The current applicability status of the product’s category in the SII reform list has been confirmed (practical estimate)
• □ The declaration of conformity has been prepared to SII requirements and is traceable to technical evidence
• □ The scope has not been misjudged for goods outside food, vehicles and fire safety equipment
• □ AMAR registration and the import permit are still proceeding through the full process
• □ A quarterly review of the category list has been scheduled
• □ CB certificates and EMC reports are ready as a fallback where the exemption does not apply (Part 29 of this guide)

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 coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com