The Israeli Registration Holder (IRH): Who May Hold a Device Registration

1. Key takeaways

Section 3(b) of Israeli law provides that a registration application must be submitted by an Israeli resident or a company registered in Israel. Foreign manufacturers cannot hold the registration themselves and must appoint an Israeli Registration Holder (IRH). The IRH is normally required to hold ISO 9001, and its duties cover new registrations, renewals, changes, import permits, adverse event and field safety corrective action (FSCA) reporting, as well as tracking regulatory measures taken abroad and reporting them to the Minister of Health. The registration is held in the name of the IRH. This is the root of the “registration hijacking” risk and the core reason for appointing an independent third-party IRH.

• Only an Israeli resident or an Israeli-registered company may submit a registration application, so every foreign manufacturer must act through a local IRH.
• Because the registration is legally held in the IRH’s name, market access in Israel is physically in the hands of a local entity rather than the manufacturer.
• IRH duties span the full product lifecycle: new registrations, renewals, changes, import permits, adverse event reporting, FSCA reporting and monitoring of foreign regulatory measures.
• If the distributor also serves as the IRH, ending the commercial relationship can put the registration itself on the negotiating table.
• An independent third-party IRH keeps the registration asset separate from commercial agency arrangements.
• The four-dimension evaluation of qualification, capability, independence and exit applies to any candidate IRH before signature.

2. Legal basis

The IRH requirement rests on the Medical Equipment Law, 5772-2012, read together with the Medical Equipment Regulations, 5773-2013. The table below sets out the instruments, the key provisions and the current practical position. Regulatory information was verified as of October 29, 2026 against official Israeli legal databases and authoritative public sources; AMAR procedural documents are updated frequently, so the current version published on the Israeli Ministry of Health website should be treated as authoritative before any formal submission.

3. Expert insights

The defining feature of the IRH system is that registration rights and commercial agency rights can be separated, but can also be bundled. Using the distributor as the IRH is legally permissible. However, binding market access to a commercial partner means that once the partnership ends, the registration itself becomes a bargaining chip: changing distributors may effectively mean re-registering the product. This is the structural mechanism behind the “registration hijacking” scenario, and it is why the identity of the IRH deserves the same scrutiny as any other market entry decision.

When GRZAN evaluates a proposed IRH arrangement, it examines four dimensions in turn, because a weakness in any one of them can surface later as an operational or commercial problem.

The qualification dimension. The candidate must have Israeli entity status, must hold ISO 9001, and, depending on the product category, must employ the qualified professional required by Regulation 22 of the Regulations (see Part 32 of this guide for the category-specific rules). These are threshold conditions: without them, the arrangement cannot function at all.

The capability dimension. The IRH must be able to hold the complete technical documentation package (see Part 22 of this guide), must be able to build an adverse event reporting chain (see Part 42 of this guide), and must be able to fulfil the periodic obligation to monitor global regulatory developments. The last item is a requirement that is relatively unique to Israel: the IRH must proactively track restrictive measures adopted by regulators in other countries against the device, and must report to the Minister of Health any information that could affect safety in Israel.

The independence dimension. The question here is whether the IRH and the distributor are the same entity. The value of an independent third-party IRH is straightforward: when the distributor is replaced, the registration is not affected, and market continuity survives the commercial transition.

The exit dimension. The agreement should provide for what happens when the relationship ends: transfer of the registration, handover of records, and transitional arrangements that keep the product on the market while the switch is executed. An arrangement that has not been designed with its own termination in mind is incomplete.

4. Practical recommendations

• Prefer an independent third-party IRH. Keep the registration asset separate from commercial agency relationships, and avoid the hijacking risk by design rather than by negotiation after the fact.
• Put four clauses in writing in the agreement: control of the registration, rights of access to records, obligations to report changes, and transfer arrangements on termination of the relationship.
• Make the global regulatory monitoring obligation concrete. Specify in the agreement the scope of monitoring, the frequency, and the deadlines for reporting to the authorities.
• Test document custody and retrieval capability. Require the IRH to demonstrate that it can produce the full technical documentation within 48 hours (practical estimate).

5. Verification checklist

• □ The IRH is an Israeli resident or an Israeli-registered legal entity
• □ The IRH holds a valid ISO 9001 certificate
• □ Whether the IRH employs a qualified professional has been confirmed for the product category (Regulation 22)
• □ The agreement covers registration control, record access, change reporting and transfer on termination
• □ Monitoring and reporting obligations for global regulatory restrictive measures are written into the agreement
• □ The IRH’s technical document custody and retrieval capability has been verified (practical estimate)

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 coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com