Advertising Restrictions for Medical Devices under Section 12 in Israel

1. Key takeaways

Section 12 of the Israeli Medical Equipment Law authorises the Ministry of Health to restrict the type and form of medical device advertising; where advertising causes or may harm the public, the Ministry of Health may order the registration holder to stop sales, to sell subject to conditions, or to restrict the form of advertising. Applying in parallel are the prohibition of misleading advertising under the Consumer Protection Law and Ministry of Health Rule 13/2018 restricting commercial interactions with healthcare institutions. On penalties (per a legal review summary): courts may fine individuals up to 150,000 new shekels and companies 300,000 new shekels; violation of an order relating to device advertising carries up to 1 year imprisonment and fines up to 226,000 new shekels, doubled for companies. These figures make advertising compliance a board-level topic rather than a marketing housekeeping matter, because the statutory ceiling for a single violation is high enough to be material for any market entrant.

2. Legal basis

The table below sets out the advertising provision, the related statutes, and the penalty figures as commonly summarised in legal practice.

3. Expert insights

The consequence structure for advertising violations in Israel differs from other markets: the consequences do not stop at a fine but can extend to market access itself. Section 12 authorises the Ministry of Health to order cessation of sales, which means that a single non-compliant promotional campaign can interrupt the sale of the product in Israel. GRZAN therefore classifies advertising compliance as business continuity risk, not marketing compliance risk. Treating it as an ordinary marketing matter understates the statutory power attached to Section 12, and it also mis-assigns the internal owner: review of promotional materials should sit with the regulatory function, with marketing executing, rather than the reverse. Companies that invert this order typically discover the problem only when a stop-sale order is already on the table.

Three boundaries deserve to be clearly understood by companies:

Boundary one: the indications boundary. The indications stated on the registration certificate are the ceiling for promotion. Section 2(a)(3) of the Law requires use to conform to the registered indications, so promoting uses beyond the registered indications touches both the advertising restriction and the use restriction at the same time. Every promotional claim should therefore be traceable to a sentence in the certificate, and the traceability should be visible in the approval record for each material, so that an auditor can follow the chain from claim to certificate without interpretation.

Boundary two: the audience boundary. Advertising directed at the public and promotion directed at professionals are subject to different regulatory intensity. For household devices aimed at non-professional audiences, the trilingual labelling and instructions-for-use requirements of Section 23 apply in addition, so the same claim may need different language versions and different levels of technical support depending on the audience.

Boundary three: the commercial interaction boundary with healthcare institutions. Ministry of Health Rule 13/2018 restricts healthcare institution staff from accepting gifts, and promotional materials may not be placed on healthcare institution premises without prior authorisation. What this constrains is the way companies interact with hospitals and physicians, not the content of advertising itself. Local sales teams need their own compliance rules for this, separate from the marketing review process, and the training records should be kept with the same care as quality system records, since they are the evidence that the company took the Rule seriously if an interaction is ever questioned.

4. Practical recommendations

• Check promotional materials against indications: compare all external materials word for word with the registered indications, and delete anything beyond them.
• Establish a material approval process: promotional materials for the Israeli market are released only after sign-off by the regulatory responsible person.
• Design materials by audience: separate sets of materials for public and professional audiences, with language and technical depth kept apart.
• Train on healthcare institution interaction compliance: deliver dedicated training on Rule 13/2018 to the local sales team and keep records.

5. Verification checklist

• □ All promotional materials have been checked word for word against the registered indications
• □ A sign-off process requiring regulatory approval before material release is established
• □ Materials for public audiences and professional audiences are designed separately
• □ The trilingual labelling and instructions-for-use requirements for household devices are satisfied in parallel (Section 23)
• □ Training on healthcare institution interaction rules (Rule 13/2018) is completed and documented
• □ The penalty figures have been reported to management and entered into the compliance risk register (practical estimate)

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

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 manages adverse event reporting and recall coordination with the MOH, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com