Adverse Event and FSCA Reporting Obligations for Medical Devices in Israel

1. Key takeaways

Post-market vigilance in Israel places the Israeli Registration Holder (IRH) under the primary statutory duty to report. The IRH must report to the Ministry of Health abnormal events occurring inside and outside Israel, field safety corrective actions (FSCA), recalls, and relevant notifications issued by foreign regulatory authorities, including the FDA. Section 13 of the Regulations (5773-2013, published on 12 June 2013) additionally provides that where a device does not conform to the registration requirements or has a defect that may harm patients, its sale must be stopped immediately, and the registration holder must withdraw the equipment in accordance with the directions of the Director General. GRZAN has reviewed the current texts of the Law and the Regulations and found no unified hourly or daily reporting deadline: the specific time limits are those set out in the current AMAR forms and procedural documents (practical estimate). Companies should therefore treat the AMAR forms as the operative source for deadlines and confirm them at the moment of each event rather than relying on memorised figures, because a figure remembered from a previous version of a form is precisely the kind of error that surfaces during an inspection rather than during routine work.

2. Legal basis

The table below consolidates the provisions governing adverse event reporting, field safety corrective actions and market withdrawal in Israel, together with their parent legislation.

3. Expert insights

The structural feature of the Israeli vigilance system is that the IRH is the single external interface. Manufacturers do not interact with AMAR directly; all adverse event and FSCA information must be submitted through the IRH. This design concentrates responsibility on the local entity, and it also means that the efficiency of information transfer between the manufacturer and the IRH directly determines the quality of compliance. A slow or incomplete internal channel will surface as a late or incomplete regulatory report, with no procedural way to separate the two.

Three practical requirements follow from this structure:

Requirement one: the reporting chain must be verifiable in both directions. The manufacturer must provide the IRH with the manufacturer investigation report, batch production records and corrective and preventive actions (CAPA) as soon as possible after becoming aware of an event; the IRH must confirm receipt and report to the Ministry of Health. GRZAN recommends building a four-stage record covering awareness, transfer, submission and feedback, with a timestamp at every stage, so that any later question about timing can be answered from documents rather than recollection.

Requirement two: foreign information must be reported too. This is the point that distinguishes Israel from most markets: the IRH must report notifications from foreign regulatory authorities, including the FDA, to the Ministry of Health. This requires the manufacturer to synchronise global safety information to the IRH, not merely local Israeli events. A recall or safety communication in another market is therefore a reporting trigger in Israel as well, and the synchronisation arrangement must be standing rather than ad hoc.

Requirement three: stopping sales and withdrawing the device are mandatory actions. Section 13 of the Regulations uses the formulation that sale must be stopped immediately, and the device must be withdrawn as directed by the Director General. This is not a commercial decision for the company to weigh on its own: once a defect that may harm patients has been identified, stopping sales is a statutory obligation. Delay in order to assess commercial impact is itself a compliance failure.

4. Practical recommendations

• Build a four-stage reporting chain: awareness, transfer, submission and feedback each leave a timestamp, so the chain remains auditable end to end.
• Synchronise global safety information to the IRH: bring notifications from the FDA, the European Union and other markets into the scope of the standing synchronisation arrangement.
• Link to the batch ledger described in article 39: define the scope of a withdrawal by batch to avoid an unnecessarily broad recall.
• Standardise CAPA documentation: turn the manufacturer investigation report, batch records and CAPA into standard templates to shorten response time.

5. Verification checklist

• □ The reporting chain between the manufacturer and the IRH is established and all four stages of records carry timestamps
• □ The synchronisation scope for foreign regulatory notifications covers the FDA and the European Union
• □ Templates for the manufacturer investigation report, batch records and CAPA have been standardised
• □ The trigger conditions for stopping sales and withdrawal are written into quality system documentation (Section 13)
• □ The definition of withdrawal scope is linked to the batch ledger (Section 24)
• □ Reporting time limits have been confirmed against the current AMAR forms and procedural documents (practical estimate)

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

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 adverse event reporting and recall coordination with the MOH, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com