Post-Market Obligations under Section 7 of the Israeli Medical Equipment Law

1. Key takeaways

Section 7 of the Israeli Medical Equipment Law, 5772-2012, authorises the Director General to set continuing conditions for the duration of the registration period. These conditions may cover initial batch testing, restrictions on the qualifications of persons using the device, a requirement that the device be used only under the direction of a physician, requirements concerning packaging quantity and type, quality, labelling and safety, device marking, restrictions on the manner and content of publication, distribution of instructions for use to users, transport and storage conditions, and continuous supply and service maintenance for consumers outside healthcare institutions. The Director General may also exempt a device from some of these conditions at the request of a healthcare institution or a device company. Violation of the conditions in Section 7(a) is a ground for cancellation of registration under Section 9(a)(3) of the Law. On the Israeli Registration Holder (IRH) side there are additional periodic post-market reporting obligations and an obligation to monitor regulatory measures taken abroad. Taken together, these provisions mean that registration in Israel is not a one-off approval event: it creates a continuing set of legal duties that remain in force for as long as the device stays on the register, and every one of them is directly linked to the risk of losing that registration.

2. Legal basis

The table below summarises the legal instruments, provisions and practical references on which this article is based, all verified against official Israeli legal sources.

3. Expert insights

In substance, the list of conditions in Section 7(a) operates as a post-market compliance checklist. Three of these conditions are the most challenging for foreign manufacturers:

First: distribution of instructions for use to users (Section 7(a)(6)). This requirement elevates the duty to deliver instructions for use from a practice of simply enclosing them with the goods to an explicit statutory condition, and the language requirement is linked to the trilingual rule of Section 23 (articles 25 and 26 of this column). For household devices, the absence of instructions in any one of Hebrew, Arabic or English constitutes non-compliance. In practice this means the manufacturer and the IRH must jointly control the language versions shipped to the market, verify them at each revision, and keep evidence that the correct set of instructions actually accompanied every consignment delivered to Israeli users.

Second: continuous supply and service maintenance for consumers outside healthcare institutions (Section 7(a)(8)). This is an obligation that is relatively unique to Israel. For devices sold to individual consumers, the registration holder must guarantee continuous supply and maintenance service. It brings the questions of whether the product can always be purchased and whether it can be repaired within the scope of compliance, and it constrains any enterprise planning to exit the Israeli market (article 40 of this column). A manufacturer cannot simply stop shipping spare parts or discontinue service for a registered consumer device without addressing this condition.

Third: restrictions on the manner and content of publication (Section 7(a)(5)) combine with the advertising restrictions of Section 12 of the Law. Publication content relating to the device is subject to regulatory constraints, and the consequences of a violation can extend to cessation of sales (article 46 of this column). Marketing teams should therefore treat these conditions not as legal footnotes but as direct constraints on everyday commercial activity.

The reporting obligations on the IRH side run along two main lines: periodic post-market reports (used for renewal, mandatory for Class III devices and Class D IVDs, see article 44) and monitoring of regulatory measures taken abroad (tracking restriction measures adopted by regulators in other countries with respect to the device, and reporting to the Minister of Health any information that may affect safety in Israel). The second line is a requirement relatively unique to Israel and is also where many IRHs fall short, because it demands a sustained multi-country regulatory monitoring capability rather than a mere document submission capability. Companies selecting or managing an IRH should evaluate this capability explicitly rather than assuming it exists.

4. Practical recommendations

• Turn Section 7(a) into a compliance checklist: go through the conditions one by one, marking the responsible party (manufacturer, IRH or importer) and the method of verification for each item.
• Keep records of instructions-for-use distribution: verify distribution records accompanying shipments, version control and completeness of language versions together, so that the evidence chain is continuous.
• Build the continuous supply commitment into the exit plan: for products sold to individual consumers, arrange alternative supply or maintenance solutions before any withdrawal from the market.
• Write the IRH monitoring capability into a service level agreement: define the countries to be monitored, the frequency of monitoring and the deadlines for reporting, so that the obligation is measurable.

5. Verification checklist

• □ The ten conditions of Section 7(a) have been reviewed item by item and the responsible parties are clearly identified
• □ Distribution of instructions for use and completeness of language versions have been verified and documented
• □ Continuous supply and maintenance arrangements for individual consumers have been implemented
• □ Monitoring records for transport and storage conditions are complete (Section 7(a)(7))
• □ The preparation schedule for the IRH periodic post-market report has been determined
• □ The obligation to monitor regulatory measures taken abroad has been written into the IRH service level agreement

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