Clinical Evaluation and Clinical Trials in Israel

1. Key takeaways

The legal basis for clinical trials in Israel is the Public Health Regulations (Clinical Trials in Humans), 5741-1980. The sequence of determination has three steps. First, examine whether the trial qualifies as a special trial: research conducted with a device already approved in a reference country, at the approved doses and for the approved indications, is a special trial and requires only the approval of the institutional Helsinki committee and the head of the institution, without Ministry of Health approval. Second, a non-special trial additionally requires the approval of the Ministry of Health Director General (represented by the clinical trials unit). Third, multi-centre research involving three or more Israeli institutions requires, since January 2020, the additional approval of the National Committee for Multi-Centre Research (Ministry of Health Guideline No. 168, pilot project). Trials must be registered on the Ministry of Health website, sponsors must update at least quarterly, and a clinical safety report must be submitted 1 year after completion.

• The special/non-special determination comes first because it fixes the length of the entire approval chain.
• Devices using the reference-country pathway can run local clinical verification at institutional level only, which shortens the cycle markedly (practical estimate: 2–4 months).
• Registration and reporting duties fall on the sponsor and run on a separate track from AMAR registration.
• Article 4(8) of the Medical Equipment Law provides a lawful channel for clinical evaluation in a limited number of patients while the Israeli registration application is under review.

2. Legal basis

The table below records the regulations, the companion guidelines, the international standards and the parallel laws that frame clinical trials in Israel.

3. Expert insights

For device companies, the most valuable single feature is the recognition of a special trial: research conducted with a device already approved for marketing in a reference country (the United States, member states of the European Union, Switzerland, Norway, Iceland, Australia, New Zealand, Japan), at the approved doses and for the approved indications, is a special trial and need not pass through Ministry of Health level approval. This means that most local clinical verification undertaken to support Israeli registration can be completed at institutional level, with a markedly shorter cycle (practical estimate: 2–4 months).

Scenarios that trigger the non-special classification include: use of a device not approved in any reference country, conduct beyond the approved indications or doses, research involving human genetics, and research related to assisted reproduction. The last two categories additionally require submission to the supreme Helsinki committee for assessment, which lengthens the chain further and should be identified at the planning stage rather than after the protocol is fixed.

The second point of interest is the registration and reporting obligations: trials that are controlled and prospective, involve medical intervention, and examine health outcomes must be registered on the Ministry of Health website; the sponsor registers after obtaining ethics committee approval (form 6) and obtains the institutional authorisation to proceed (form 7); the information must be reviewed and updated at least quarterly; and a clinical safety report is due one year after completion of the research. These obligations rest on the sponsor and run on a line separate from AMAR registration, so they need their own owner and calendar.

The third point of interest is the link to Article 4(8) of the Medical Equipment Law: devices already approved in a reference country whose Israeli registration application is under review may be used by health institutions for clinical evaluation in a limited number of patients. This is the lawful channel of registration pending plus clinical evaluation first (see article 8), and it is often the deciding factor in planning the Israeli entry sequence.

4. Practical recommendations

• Make the special/non-special determination first. This step decides the length of the approval chain and should be completed before the protocol is finalised.
• Ensure reference-country approvals cover the trial indications. The moment the trial moves beyond an approved indication, it falls into the non-special category.
• Plan multi-centre research early. Research at three or more institutions must go through the National Committee for Multi-Centre Research, so scheduling must start well in advance.
• Manage sponsor duties separately. Set independent reminders for the three obligations: registration, quarterly updates, and the clinical safety report one year after completion.

5. Verification checklist

• □ The special/non-special trial determination has been completed and its basis is retained on file
• □ The device used in the trial has reference-country approvals covering the trial indications
• □ Approvals of the institutional Helsinki committee and the head of the institution have been obtained
• □ For non-special trials, Ministry of Health (clinical trials unit) approval has been obtained
• □ Multi-centre research at three or more institutions has been submitted to the National Committee for Multi-Centre Research
• □ Registration on the Ministry of Health website (forms 6/7) is complete, with reminders set for quarterly updates and the report after 1 year

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

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 prepares MOH-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com