Home-Use versus Professional Labeling under Regulation 23(c)

1. Key takeaways

Article 23(c) of the Israeli Regulations (Regulations 5773-2013, published 12 June 2013) provides that, for non-home-use devices, the Director may, at the request of the distributor, exempt from part of the trilingual marking requirements of Article 23(a). The practical estimate in the market is that devices intended for non-professional users (home use) must be supplied in 3 languages (Hebrew, Arabic and English), while devices used only by professionals in medical institutions may be supplied in English only. The exemption does not take effect automatically — it must be requested by the distributor from the Director and granted, and the company must retain the record of the approval.

• Language coverage follows the declared intended use, not the actual sales channel: home-use framing triggers trilingual labeling even if the product is in fact sold only to hospitals.
• The exemption is built on a request-and-approval structure, so an approval record is indispensable to rely on it.
• Extending use from professional to home use is an intended-use change that normally constitutes a major change under the rules of article 43 and may require re-registration, not merely a label change.
• Trilingual terminology must be consistent across the label, the instructions for use and the Register.

2. Legal basis

The table below records the exemption provision, the ten-category trilingual requirements it modifies, the parent law, and the practical estimate applied by AMAR.

3. Expert insights

The commercial value of this exemption depends on how the intended use is written. The most typical cost trap GRZAN has observed runs as follows: the product could perfectly well be sold in professional channels, but in order to widen the market the company writes into the intended use that the device may be used by patients themselves or is suitable for home self-testing. With those words in place, the device is classified as a home-use device, and the full localisation cost of trilingual labeling and trilingual instructions for use is triggered — long before any home user actually buys the product.

Three principles of judgement follow from this.

Principle one: the intended use determines the language cost, not the sales channel. Even if the device is in fact sold only to hospitals, so long as the declared intended use permits non-professional use, it may be regulated according to the requirements for home-use devices. The declaration and the channel must therefore be kept deliberately aligned, because the regulator reads the file, not the sales ledger.

Principle two: the exemption is a request-and-approval structure and must be documented. Article 23(c) is drafted so that the Director may, at the request of the distributor, grant the exemption. This means the exemption is not a self-assessed status that relieves the company of obligation; it must be supported by a record of approval. GRZAN recommends filing the exemption approval letter together with the registration documents, so that the reliance on English-only labeling can be evidenced on demand.

Principle three: a change of use triggers a corresponding change of labeling. Extending from professional use to home use is a change of intended use, and under the rules of article 43 it normally constitutes a major change, potentially requiring re-registration — and not merely a label replacement. The timeline and cost of that re-registration should be anticipated before the wording of the intended use is widened, not discovered afterwards.

Taken together, the three principles show that the cheapest labeling outcome is decided at the moment the intended use is drafted, which is why language economics should sit at the same table as clinical and marketing decisions.

4. Practical recommendations

• Calculate the language cost before finalising the intended use. Estimate the trilingual translation, layout, validation and printing costs against the number of SKUs before settling the wording of the intended use.
• Put the exemption request in writing and archive it. The request is made by the distributor to the Director; retain the approval letter and manage it in the same file as the registration documents.
• Validate localisation for home-use products. Trilingual instructions for use should be reviewed by local professional translators, with terminology kept consistent with the label.
• Treat use extensions as major changes. Where use is extended from professional to home use, plan in advance for the timeline and cost of re-registration.

5. Verification checklist

• □ The wording of the intended use clearly limits use to professional use or permits home use, and is consistent with the actual channel
• □ Trilingual labeling and instructions for use for home-use devices have completed localisation and review
• □ For non-home-use devices, the exemption request has been made by the distributor and approved by the Director (Article 23(c))
• □ The exemption approval letter has been archived together with the registration documents
• □ Plans to extend use have been assessed as a major change (see article 43)
• □ Trilingual terminology is consistent across the label, the instructions for use and the Register

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