Director-General Permits under Section 4 and the 2-Year Wind-Down

1. Key takeaways

Section 4 of the Israeli Medical Equipment Law opens a permit channel for unregistered devices: where the Director is satisfied that public health will not be harmed, permits may be granted for nine categories of use (necessary medical care, research, development and manufacturing, emergency preparedness and emergency use, export only, continued use of de-registered equipment by health institutions, use beyond the registered intended use, clinical evaluation in a limited number of patients of devices already approved in a reference state and under review in Israel, and personal use). Section 10 adds a wind-down buffer: after expiry without renewal, deletion or cancellation, the device may still be marketed and used (imports excluded) for not more than 2 years from the end of the registration period. Both mechanisms depend on the public-health condition being satisfied and on the scope stated in the application being respected, and neither substitutes for a registration that can be maintained.

• Section 4 permits unregistered devices for nine categories of use, subject to public health.
• Permits cover necessary care, research, development, emergencies, export-only, de-registered equipment, off-label use, limited-patient clinical evaluation and personal use.
• Devices approved in a reference state and under review in Israel may be used for limited-patient clinical evaluation.
• Section 10 allows continued marketing and use, without imports, for up to 2 years after registration ends.
• The 2-year window is a stock-clearance window, not a licence to keep operating.

2. Legal basis

The permit scheme and the post-registration window both sit in the parent law, supported by notice duties in the 2013 regulations. The elements cited in this article are listed below.

3. Expert insights

Within Section 4, the commercially most valuable provision is item (8): a health institution may use a device that has already been approved for marketing in a reference state and whose registration application has been filed in Israel but not yet granted, for clinical evaluation in a limited number of patients. This lawfully links pending registration with clinical use first – a company does not have to wait for the certificate before accumulating clinical experience in Israel. In innovative-device projects GRZAN typically designs this route together with the clinical-trial approval pathway.

The necessary medical care of Section 4(1) and the emergency preparedness and emergency use of Section 4(4) are routine instruments in Israel during public health events and supply interruptions. Companies use them rarely in normal times, but should know they exist – where a reference-country certificate lapses temporarily or a renewal creates a timing gap, such permits can maintain continuity of supply.

The 2-year allowance of Section 10 is often misread as a grace period. Its precise meaning is that once a registration has lapsed, products already circulating in the market may continue to be sold and used, but may no longer be imported. It is in effect a stock-clearance window, not a licence to continue business. A company planning to exit the Israeli market should execute it together with the non-renewal notice duties of Section 14 of the regulations (written notice to the Director, and public announcement to medical institutions and the public).

Two further points about the permit mechanism are worth registering. First, because Section 4 permits are granted per purpose and per situation, they are bespoke instruments: the scope stated in the application – institution, patient numbers, duration, supervision – becomes the boundary of lawful use, so an underspecified application yields a permit that is too narrow to be useful. Second, the linkage between Section 4 and Section 10 means a company should map its exposure before relying on either: how long the reference-country certificate will hold, whether a renewal gap is foreseeable, and how much stock is in the Israeli channel at any given time. Those three numbers determine whether the permit route is a genuine contingency or only a theoretical one.

4. Practical recommendations

• Combine pending registration with limited patients for innovative devices: after filing the registration application with AMAR, start a limited-patient clinical evaluation with a local health institution and accumulate local use data in parallel.
• Specify the use and scope in permit applications: Section 4 permits are granted by purpose; the application must state the institution, the number of patients, the time limits and the supervision arrangements.
• Exit the market in three steps: written notice of non-renewal → announcement to medical institutions and the public → clear the stock within the 2-year window (imports stopped).
• Pre-establish emergency fallbacks: write the use of Sections 4(1)(4) as a continuity plan for reference-certificate lapses into the quality system documentation.

5. Verification checklist

• □ Whether any situation for a Section 4 permit exists has been assessed (research, necessary care, export, emergency, limited-patient clinical evaluation, etc.)
• □ Permit applications state the purpose, institution, number of patients and time limits
• □ If exit is planned, the written notice of non-renewal and announcement procedure has started
• □ It has been confirmed that no new imports are scheduled within the 2-year window
• □ The stock clearance plan is aligned with the return terms in distributor agreements
• □ Use records under Section 4 permits are included in post-market reporting

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