The Medical Equipment Register under Section 3: Public Access

1. Key takeaways

Section 3 of the Israeli Medical Equipment Law (law published on 14 May 2012) establishes three rules: the Director must maintain a register of medical equipment that is open to public inspection; a registration application must be made by an Israeli resident or a company registered in Israel; and registration confers no rights in the registered device and does not derogate from existing rights. The register can be searched publicly at registries.health.gov.il; it is both a compliance asset for companies and a source of competitive intelligence. A certificate copy must be issued by the Director within 7 working days on request, so the register is designed to be relied upon in everyday business.

• The Director maintains a public register of medical equipment.
• Only an Israeli resident or an Israeli-registered company may apply for registration.
• Registration confers no rights and does not derogate from any existing rights.
• The register is publicly searchable at registries.health.gov.il.
• Qualified professionals are required by regulation for specified device categories.

2. Legal basis

Section 3 is drafted in five lettered sub-paragraphs, each addressing a distinct aspect of the register, and is supplemented by certificate-issuance duties in the 2013 regulations. The elements cited in this article are listed below.

3. Expert insights

Section 3(e) is a sentence that is easily skipped yet has real substance for companies: registration confers no rights and does not derogate from any rights. Its meaning is that AMAR registration settles only the administrative question of market access and has nothing to do with private rights such as patents, trademarks or designs. A company cannot claim exclusivity by pointing to a registration number, and a competitor registering the same type of product does not infringe any right of the first registrant.

Section 3(d) plants a professional threshold: for categories such as life-support and life-sustaining equipment, implants, devices containing medicinal preparations, imaging equipment and laser equipment, the Minister may provide by regulation that the relevant applications and acts must be handled by professionals holding specified qualifications. Section 22 of the regulations concretises this requirement into a list of degrees and practising qualifications. This means not just any Israeli company can hold the registration – the staffing of the registration holder is substantively constrained by law.

GRZAN also observes the two-way value of the register. Public search lets manufacturers verify the accuracy of their own records (models, holder, validity period), and it also serves as a market-research tool: searching by country of manufacture, holder or category reconstructs competitors’ registration arrangements and launch rhythm in Israel. For manufacturers entering the market, checking whether the same model has already been registered by another importer is a mandatory step before entry – once the model is held by someone else, the new entrant must either negotiate a change of holder or file a separate application.

Two further implications of the eligibility rule in Section 3(b) deserve attention. First, because the applicant must be an Israeli resident or an Israeli-registered company, the choice of that entity is a long-term commitment rather than a formality: the register records the holder, and every later correction, renewal and notification runs through it. Second, the fact that the register is open to public inspection cuts both ways – the same search that lets a company verify its own records lets competitors see who holds which models and until when. Companies should therefore treat register entries as published information and keep the entries accurate at all times, since an outdated holder name or validity period visible to the public can disrupt distributor negotiations and hospital onboarding. The register search itself requires no login, so records can be checked and archived at any time, and the same search should be repeated quarterly as a standing self-check.

4. Practical recommendations

• Search the register before entering the market: retrieve existing registration records for the model to be declared to avoid conflicts with an existing registration arrangement.
• Reconcile records annually: compare the model, holder name, address and validity period shown in the register with the certificate, and apply for correction immediately if discrepancies appear.
• Pre-qualify the holder’s staff: if the product belongs to the life-support, implant, imaging or laser categories, confirm that the IRH employs the qualified professionals required by Section 22 of the regulations.
• Manage registration and intellectual property separately: the register being public does not make technical files public, but the technical summaries submitted in a dossier become inspectable content, so run a disclosure review before submission.

5. Verification checklist

• □ Existing register records for the model to be declared (including holder and validity period) have been archived as screenshots
• □ The details on the registration certificate match what the register displays
• □ Whether the IRH employs the qualified professionals required by Section 22 of the regulations (checked by category)
• □ The technical summaries to be submitted have passed a disclosure review
• □ A quarterly self-check mechanism against the register has been established
• □ The agreement with the IRH includes an obligation to notify changes to register information

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