Distributor Records in Israel: Three-Year Document Retention Requirements

1. Key takeaways

Regulation 24 of the Israeli Regulations provides that the registration holder must, upon the Director’s request, disclose the identity of distributors, and must keep the relevant documents for at least 3 years counting from the date of delivery of each batch. This is the statutory floor for distribution traceability of devices in Israel, and it connects directly to adverse event reporting and market withdrawal (Regulation 13). GRZAN’s recommendation is to treat the 3-year period as a minimum and to apply the longer of that period and the product lifecycle or reference-country requirements.

• Distributor identity must be disclosed on request by the Director; the duty to answer is continuous, not a one-off filing.
• Documents must be kept for at least 3 years from the delivery date of each batch.
• The counting point is batch delivery, so the ledger must be organised by batch, not by product.
• Import distributors and sub-suppliers must be named in the application (Regulation 3(a)(6)), and the live list must be maintainable thereafter.
• The batch-to-distributor mapping is the operational basis of any recall executed under Regulation 13.
• Change of distributor triggers notification duties under Regulation 15.
• For continuously supplied products, retention in practice runs to the last batch delivered plus 3 years.

2. Legal basis

The traceability obligations sit in the Medical Equipment Regulations (Registration of Medical Equipment in the Register and Renewal thereof), 5773-2013, supported by the continuous obligations in Section 7(a) of the parent Medical Equipment Law, 5772-2012. The table below lists the instruments and provisions. 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 on the Israeli Ministry of Health website governs before formal submission.

3. Expert insights

Regulation 24 combines two things in one provision: the disclosure duty (informing the Director of distributor identities upon request) and the retention duty (keeping documents for at least 3 years from batch delivery). Together they constitute the distribution traceability chain in Israel, and each has consequences that are easy to get wrong in practice.

Three practical points deserve attention.

Point one: the clock starts on the batch delivery date, not the registration date. This means every batch starts its own 3-year period, so the ledger must be organised by batch rather than by product. For a product that is supplied continuously, the actual retention requirement runs to “the last batch delivered plus 3 years”, which is longer than most companies initially assume.

Point two: the distributor list is dynamic information. Regulation 3(a)(6) requires the names of import distributors and sub-suppliers to be declared at the time of application, but distribution networks change. Regulation 24 resolves this dynamism through the mechanism of disclosure upon the Director’s request: companies do not need to file every change, but they must be able to produce the current list at any moment. That is only possible if the ledger is maintained in real time rather than reconstructed on demand.

Point three: the ledger is the execution basis for recalls. Regulation 13 requires sales to stop immediately where a defect could harm patients, and the affected stock to be withdrawn according to the Director’s instructions. Judging the scope of a withdrawal depends on the batch-to-distributor-to-end-user mapping. If the ledger records only who was sold to, but not which batch, the recall scope cannot be defined precisely, and the usual result is a widened recall whose cost rises significantly.

The interaction between Regulations 13, 15 and 24 is worth stating explicitly. Regulation 24 supplies the data structure; Regulation 15 requires changes in the distribution arrangement to be notified; Regulation 13 consumes the data when a defect forces a withdrawal. A ledger that satisfies Regulation 24 but is not updated when distributors change will fail at the moment Regulation 15 or Regulation 13 actually matters, which is precisely when the cost of failure is highest. Maintenance discipline, rather than document creation, is therefore the real compliance task over the life of the registration.

GRZAN’s overall recommendation on duration also bears repeating. The 3-year figure in Regulation 24 is a floor, not a target. Reference-country requirements, product lifecycle considerations and internal quality system policies may all justify longer retention, and where they conflict, the longest applicable period should govern. A single, clearly documented retention rule, applied uniformly across batches and distributors, is easier to defend in front of the Director than a patchwork of exceptions calculated batch by batch.

4. Practical recommendations

• Build the ledger by batch. Fields should include batch or serial number, delivery date, quantity, distributor, end-user institution (where obtainable), and the corresponding registration certificate number.
• Retain for the last batch plus 3 years. Calculate the retention period per batch, not per product.
• Keep the distributor list current. Institute a quarterly reconciliation so that the Director’s request can be answered at any time.
• Link the ledger to the recall plan. Use this ledger directly in recall drills to define the affected scope, and test that it works.

5. Verification checklist

• □ The distribution ledger is built by batch with complete fields (batch number, delivery date, quantity, distributor, end user)
• □ The retention period is executed as batch delivery date + 3 years
• □ The distributors and sub-suppliers declared in the application match the ledger (Regulation 3(a)(6))
• □ A quarterly reconciliation of the distributor list is in place, enabling response to the Director at any time
• □ The ledger has been incorporated into the recall plan and exercised
• □ The notification duty on change of distributor has been fulfilled under Regulation 15

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