AMAR and the Medical Equipment Law 5772-2012: Mandatory Registration

1. Key takeaways

Israel operates a system of mandatory registration: a device that is not entered in the register may not be manufactured, may not be sold, and may not be used in medical care or prescribed for medical use. The competent authority is the Medical Devices Division (AMAR) of the Israeli Ministry of Health (MOH). The legal foundation is the Medical Equipment Law, 5772-2012, published on 14 May 2012. At the operational level, the framework is completed by the Medical Equipment Regulations (Registration of Medical Equipment in the Register and Renewal thereof), 5773-2013, published on 12 June 2013 and entering into force 30 days after publication, together with AMAR’s REG series of procedural documents. Foreign manufacturers cannot submit applications on their own behalf; every application must be filed by an Israeli resident or by a company registered in Israel.

• Mandatory registration applies under the Medical Equipment Law, 5772-2012, published on 14 May 2012.
• AMAR, the Medical Devices Division of the MOH, is the competent authority, operating the portals amar.health.gov.il and registries.health.gov.il.
• The Regulations 5773-2013 (published 12 June 2013, in force 30 days after publication) and the REG procedural documents govern day-to-day filing.
• A foreign manufacturer cannot file on its own; an Israeli resident or an Israeli-registered company must act as applicant.
• The framework has three layers – law, regulations and REG procedural documents – and all three must be read together.

2. Legal basis

The table below sets out the legislative elements cited in this article, exactly as they appear in the official Israeli legal database and on AMAR’s published portals. These elements define the outer boundaries of the obligation to register before any device is placed on the Israeli market.

3. Expert insights

Israel’s regulatory system shows a three-layer structure of law – regulations – procedural documents. Understanding this layering matters more than memorising individual provisions, because each layer answers a different question and fails in a different way.

The first layer, the law, answers whether the activity is permitted at all. Section 2 establishes the prohibitions, Section 3 establishes the register, Section 4 provides the permit channels for exemptions, and Section 8 governs renewal. The second layer, the regulations, answers what must be submitted and within what time: the 25 articles cover the elements of an application (Section 3), the period for a decision (Section 5), the validity period (Section 12), labelling (Section 23) and import approval (Section 17). The third layer, the REG series of procedural documents, answers questions of format and route; it is updated most frequently and is the practical variable that decides whether a submission is accepted.

GRZAN highlights a fact that is easy to overlook: the pace of the legal texts and the pace of the procedural documents are not fully synchronised. The law has been passed by the Knesset and amended several times, while the accompanying procedures are still being progressively documented, and AMAR executes according to the written requirements. This means a company cannot rely on the statute alone – the statute defines the boundaries of responsibility, but the REG documents determine whether the current submission can actually go in.

The second point of interest is applicant eligibility. Section 3(b) of the law states clearly that a registration application must be submitted by an Israeli resident or by a company registered in Israel. This is not an arrangement of administrative convenience: it anchors legal responsibility in an onshore entity, and from it derives the irreplaceable role of the IRH, the Israeli Registration Holder.

4. Practical recommendations

• Read on two tracks: build a responsibility list from the law and the regulations, and build an operational list from the REG procedural documents; maintain both lists in parallel.
• Fix the entity before the route: before evaluating which registration route to take, identify the IRH candidate, because the IRH’s qualifications (ISO 9001), importer relationships and record-keeping capability directly determine which routes are available.
• Keep a procedural-document register: log the currently valid REG documents of AMAR, their numbers, version dates and applicable subjects, and review the register quarterly.
• Do not treat secondary translations as authority: where article numbers are cited, rely on the Hebrew text in the official legal database; use the English translation only as a reference.

5. Verification checklist

• □ Confirm whether the product falls within the legal definition of a medical device (the definitions in Section 1), rather than a medicinal product or an ordinary consumer product
• □ Confirm that an Israeli resident or a company registered in Israel has been identified as the applicant
• □ Confirm that the reference-country approval documents are valid and match the models and intended use to be declared
• □ Retrieve the current list of valid AMAR REG procedural documents and check the version dates
• □ Check the public register for existing records of the same model (registries.health.gov.il)
• □ Assign internal owners: one contact each for regulatory, quality, clinical and supply-chain matters

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