SII Testing under the SI 60601 Series

1. Key takeaways

Active electrical devices in Israel may need to be assessed by the Standards Institution of Israel (SII) under the SI 60601 series (electrical safety and electromagnetic compatibility). The SII accepts CB certificates and EMC reports issued by accredited laboratories, which can significantly compress the testing timeline. From 1 January 2025, the SII has rolled out an import reform: products that comply with European Union legislation, or that are already lawfully marketed in the EU, may be exempted from standards testing, with a declaration of conformity substituting for the test certificate; the reform proceeds by product category in phases through 2028. Whether medical devices have been brought within the current category list must be verified category by category (practical estimate).

• SII testing is a second customs-clearance track running in parallel with AMAR registration, and it is the most common time sink at the import stage.
• CB certificates plus accredited-laboratory EMC reports are accepted by the SII and avoid duplicate sample submission.
• The import reform works by amending the applicability of the Standards Law product by product, so country of origin is not the deciding factor — CE-marked goods made in China may in principle benefit.
• Food, motor vehicles and certain firefighting equipment are expressly outside the reform; medical devices must be checked against the current category list.

2. Legal basis

The table below records the testing requirements, the SI 60601 series, the import reform timeline and the parent law.

3. Expert insights

SII testing is the second clearance pathway that exists alongside device regulation. Completing registration does not mean the equipment can enter the country — active electrical products must still pass the SII. Running the two pathways in parallel rather than in sequence is the central scheduling decision, because a serial plan is the most common black hole for time in the import phase.

The key to compressing the timeline lies in using the CB certificate. Test reports and certificates issued under the CB Scheme (IECEE) are accepted by the SII, and combined with EMC reports from accredited laboratories they avoid submitting samples twice. GRZAN’s recommendation is to require the laboratory to issue a combined CB report plus EMC report at the CE certification stage, rather than only the documents needed for EU conformity — the incremental cost is limited, but the reuse value for Israel and other markets is high. Deciding this before the testing plan is signed is what locks in the saving; asking for it afterwards means re-opening the project with the laboratory.

The SII import reform beginning in 2025 deserves separate attention. Its mechanism is to amend the applicability of the Standards Law product by product, without setting limits by country of origin — products manufactured in China but bearing a valid CE mark can in principle benefit equally, although they must still submit a declaration of conformity in place of the test certificate. GRZAN flags two points: first, the reform proceeds by category in phases (standards categories from 1 January 2025, energy categories from 1 November 2024, and so on); second, food, motor vehicles and specific firefighting equipment are expressly excluded. The status of medical devices must be confirmed against the SII’s current announcements (practical estimate), because category lists are updated as the phased rollout continues.

The practical conclusion is that the applicability check belongs at the very front of the project, at the same time as the registration pathway decision, since it determines whether a test campaign or a declaration file is the export deliverable.

4. Practical recommendations

• Lock in the CB plus EMC reports at the certification stage. Request them at the same time as CE certification to avoid a second round of sample submission.
• Verify reform applicability category by category. Confirm with the SII or the Israeli registration holder (IRH) whether the category of the product under application has been brought within the reform list.
• Schedule the two pathways in parallel. Start AMAR registration and SII testing at the same time rather than one after the other.
• Prepare the declaration of conformity template in advance. If the reform applies, draft the declaration of conformity in the form required by the SII ahead of time (practical estimate).

5. Verification checklist

• □ It has been determined whether the product falls into the active electrical category
• □ The CB certificate and the accredited laboratory’s EMC report have been obtained
• □ The specific applicable parts of the SI 60601 series have been confirmed (electrical safety, EMC)
• □ The product category’s status under the SII import reform list has been verified (practical estimate)
• □ AMAR registration and SII testing have been scheduled in parallel
• □ A declaration of conformity template has been prepared to SII requirements (where the reform applies)

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

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 prepares MOH-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com