Trilingual Labeling Requirements under Regulation 23

1. Key takeaways

Article 23(a) of the Israeli Regulations (Regulations 5773-2013, published 12 June 2013) provides that devices marketed in Israel must state, clearly and indelibly, in Hebrew, Arabic and English, on the package or the instructions inside the package, ten categories of information: the trade name; the intended use and indications; the manufacturer’s name and country of manufacture; the registration holder’s name, address and telephone number; warnings and limitations (together with the note to read the accompanying instructions before use); the batch or serial number and the date of manufacture; the expiry date; the quantity in the package; the generic name of the active ingredient of any preparation (where applicable); and such other markings as the Director may instruct. Article 23(b) additionally requires the device itself to bear the batch or serial number, the date of manufacture, and the markings stated in the registration certificate.

• The ten information categories are fixed by Article 23(a) and must appear in all three languages, clearly and indelibly.
• The marking may sit on the package or on the instructions inside the package, which gives flexibility for small packages.
• The registration holder’s name, address and telephone number are part of the mandatory label content, so changing the IRH means changing the label.
• Expiry date and batch or serial number must be linked to the production batch management system, and expiry must be expressed as a definite date.

2. Legal basis

The table below sets out the provisions and the parent law, together with the practical estimate on language coverage for non-home-use devices.

3. Expert insights

The trilingual requirement of Article 23 is the core of Israeli labeling compliance, and understanding its three layers saves a great deal of rework.

Layer one: location. The provision allows the markings to appear on the package or on the instructions inside the package. This offers a flexible solution for small-package devices — where the package does not leave enough space, the trilingual information can be consolidated on the accompanying instructions for use. The choice of location should be made deliberately per SKU and then applied consistently, because a label architecture that shifts between package and leaflet across a product family is a common source of findings.

Layer two: indelibility. The provision requires the markings to be clear and indelible. This imposes demands on the printing process: an ordinary adhesive label that detaches under high temperature or in a cold-chain environment is treated as non-compliant. Durability must therefore be validated against the actual storage and transportation conditions the product will really face, not against nominal laboratory conditions.

Layer three: the registration holder’s information. Article 23(a)(4) requires the name, address and telephone number of the registration holder — that is, the IRH — to be marked. This fixes the IRH’s information onto the physical label, which means that replacing the IRH requires replacing the label. That is a hidden cost to factor in when assessing the term of an IRH cooperation, alongside the reprint, scrapping and transition-stock effects of a label change.

GRZAN adds one further point: Article 23(a) requires the marking of the expiry date and the batch or serial number, and these two items must be connected to the production batch management system. Companies that express shelf life as a manufacturing date plus a duration must convert this into a definite expiry date, so that the label, the batch records and the Register all tell the same story.

4. Practical recommendations

• Build a marking template around the ten categories. Turn the ten information categories into a trilingual template and populate it per SKU, avoiding repeated fresh translation for every new model.
• Validate printing durability. Carry out labeling durability validation under the actual storage and transportation conditions (cold chain, humidity and heat) and retain the report.
• Prepare an IRH-change plan in advance. Provide in the agreement for the sharing of label-switching costs and the handling of transition-period stock when the IRH changes.
• Assess the Article 23(c) exemption. Non-home-use devices may be granted a partial exemption from the trilingual requirements by the Director; the request must be made by the distributor and the approval retained on file (see article 26).

5. Verification checklist

• □ The label or the instructions inside the package contain all ten categories of information under Article 23(a)
• □ All three languages (Hebrew, Arabic, English) are present and terminology is consistent across them
• □ Printing durability has been validated under the actual storage and transportation conditions
• □ The device itself bears the batch/serial number and the date of manufacture (Article 23(b))
• □ The IRH name, address and telephone number are marked and match the Register
• □ The expiry date is expressed as a definite date and is consistent with the batch system

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