Israel has a modern and structured product compliance system that integrates national technical regulations, mandatory standards, and sector-specific registrations, particularly in health, safety, and telecom. It recognizes several international standards and has mutual recognition agreements (MRAs) with the EU in some sectors.

Key Authorities:

• Standards Institution of Israel (SII) – Develops and enforces Israeli Standards (IS), operates testing laboratories, and provides product certification (e.g., SII mark).

• Ministry of Health (MOH) – Regulates pharmaceuticals, medical devices, cosmetics, and food safety. Handles product registration, clinical approvals, and post-market surveillance.

• Ministry of Communications (MoC) – Manages type approval for telecommunications and radio frequency equipment.

• Israel Customs Authority – Verifies import compliance, documentation, and classification of goods.

• Ministry of Economy and Industry – Oversees consumer protection, labeling, and enforcement of technical regulations.

Key Compliance Elements:

• Mandatory Standards:

  • Over 500 product categories are subject to mandatory compliance with Israeli Standards (IS), including appliances, electrical goods, construction materials, and toys.

  • Testing and certification are often required through SII or a recognized conformity assessment body.

  • For certain categories, EU CE-marked products may be exempt from local testing under regulatory reforms or MRAs.

• Product Registration:

  • Pharmaceuticals, cosmetics, food supplements, and medical devices must be registered with the Ministry of Health.

  • Registration requires technical documentation, safety data, proof of GMP or ISO certification, and Hebrew-language labeling.

• Type Approval (MoC):

  • Telecom and wireless equipment (e.g., mobile phones, routers, IoT devices) require MoC type approval.

  • Depending on the product category, Israel may accept FCC or EU RED-compliant test reports as part of the application.

• Labeling Requirements:

  • Labels must be in Hebrew, and include:

    • Product name

    • Manufacturer/importer name and contact

    • Country of origin

    • Usage instructions and warnings

    • Batch/lot number and expiration date (where applicable)

    • Certification marks (e.g., SII, CE, MoC number)

• Market Surveillance:

  • SII, MOH, and consumer protection authorities regularly inspect products in the market.

  • Non-compliant or unsafe goods may be recalled, fined, or blocked from entry.