Section 2 of the Medical Equipment Law: Prohibition on Unregistered Devices

1. Key takeaways

Section 2 of the Israeli Medical Equipment Law (law published on 14 May 2012) establishes three prohibitions: an unregistered device may not be manufactured or sold; it may not be prescribed for medical use or used for medical purposes; and a registered device must be used in accordance with the intended use and registration conditions stated in its registration certificate. There are two exceptions: devices listed in the Second Schedule to the law, and categories of devices exempted from registration by order of the Minister of Health with the approval of the Health Committee of the Knesset. The consequences of breach go beyond fines – Section 12 of the law authorises the Ministry of Health to order a cessation of sale where advertising may harm the public. In short, the certificate defines what may be sold and how it may be used, and the register number is what hospital procurement will ask to see.

• Section 2(a) prohibits manufacturing and sale of unregistered devices.
• Unregistered devices may not be prescribed or used for medical purposes.
• Registered devices must be used according to the intended use and registration conditions in the certificate.
• Exceptions: the Second Schedule and ministerial exemption orders approved by the Knesset Health Committee.
• Section 12 allows the Ministry of Health to order a halt to sales where advertising may harm the public.

2. Legal basis

The prohibitions rest on the parent law and are supplemented by conditions in the 2013 regulations. The elements cited in this article are summarised below, exactly as they appear in the official Israeli legal database.

3. Expert insights

The structure of Section 2 rewards close reading, because its object is not limited to the party that sells.

Section 2(a)(2) brings prescribing and the act of use within the scope of the prohibition, which means that hospitals and clinical departments are also subjects of the obligation. The situation GRZAN repeatedly encounters in projects is a manufacturer reasoning that it only supplies hospitals and that registration is the importer’s business, while the law writes every link of the chain into the prohibition. This is also why Israeli enforcement primarily lands on procurement compliance in medical institutions: hospital procurement systems generally require the register number to be provided.

Section 2(a)(3) limits the scope of use: the device must be used in accordance with the intended use and the registration conditions stated in the certificate. At the same time a proviso applies – prescribing or use that conforms to accepted medical practice is not subject to that restriction. This proviso leaves room for off-label use in clinical practice, and it echoes the permit for use beyond the registered intended use in Section 4(7); companies should not, however, use it as a basis for promoting off-label purposes.

The ministerial exemption order in Section 2(b) is another route that is often overlooked: with the approval of the Health Committee of the Knesset, the Minister of Health may, by order, provide that a category of devices does not require registration. The criterion is whether non-registration would harm public health, and account is taken of whether the device is also exempt from registration in the reference state. This leaves an institutional opening for low-risk categories to be exempted in the future.

Read together, the three prohibitions and the two exceptions define a closed system: everything outside the exceptions requires registration, and everything inside the registration must stay within its certificate. The practical consequence for a manufacturer is that the registration certificate is not a formality to be filed away but the operative boundary document of the Israeli business – sales, clinical use and promotion are all measured against its wording. The cessation-of-sale power in Section 12 underlines how quickly a promotional misstep can escalate: a single advertisement judged potentially harmful to the public is enough for the Ministry of Health to order sales stopped, independently of any penalty proceedings.

4. Practical recommendations

• Put the registration number into commercial documents: mark the AMAR registration number consistently on quotations, tender responses and hospital onboarding files, so procurement-side compliance review is not held up.
• Compare intended use word for word: the Israeli intended use must be verbatim identical to the reference-country approval documents; any extension is handled as a change or a fresh registration.
• Track the Second Schedule: check periodically whether the category to be declared has been added to the Second Schedule or covered by a ministerial exemption order, which can save the whole registration process.
• Document training of medical institutions: give distributors and end users written notice of the boundaries of the intended use and keep signed receipts.

5. Verification checklist

• □ Has the model to be declared obtained an AMAR registration number, or does it fall within a Second Schedule category
• □ Is the intended use stated in the registration certificate fully consistent with the actual promotional wording
• □ Do sales contracts and tender documents state the registration number and its validity period
• □ Is there an approval and record-keeping mechanism for off-label use requests
• □ Are the Second Schedule and ministerial exemption orders reviewed once per quarter for updates
• □ Do distributor agreements state that promotion is limited to the registered intended use

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

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 Ministry of Health (MOH) registrations under the Medical Devices Law 5772-2012, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com