Israeli Government Fees for Medical Device Registration: Zero Since 2022

1. Key takeaways

Since August 15, 2022, Israel has charged no government fees for registration, changes and renewals of medical devices. Before the reform, the standard-path registration fee was approximately NIS 1,200 per item (practical estimate; historical reference). However, the statutory authority for fees remains in the text: Section 22 of the Law authorises the collection of application fees, and Regulation 3(a)(11) requires proof of payment to be submitted. GRZAN’s assessment is that zero fees are an administrative decision, not a statutory prohibition, and budget models should not assume the situation is permanent.

• Registration, changes and renewals currently attract no government fees, effective August 15, 2022.
• The declaration route is explicitly fee-free as well.
• Section 22 of the Law and Regulation 3(a)(11) together form a complete legal basis for fees should they be restored.
• Under Regulation 11, fees for rejected applications are not refunded, and a resubmission within 6 months attracts no additional charge.
• Restoring fees would require only an administrative decision, not new legislation.
• Service-side costs, not government fees, now dominate the entry budget.

2. Legal basis

The fee question is governed by the Medical Equipment Law, 5772-2012, and the Medical Equipment Regulations, 5773-2013, read together with the current administrative position announced in 2022. The table below lists the instruments, provisions and the present administrative 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 on the Israeli Ministry of Health website governs before formal submission.

3. Expert insights

The removal of fees is part of Israel’s enabling regulation reform, whose purpose is to reduce the administrative cost of bringing devices into Israel and to improve market accessibility. The reform plan itself was accompanied by calculations: the annual Israeli medical device market is close to NIS 9 billion, and after the reform more than NIS 90 million could be saved each year (practical estimate, based on public paraphrasing of the reform plan’s explanations). Whatever view is taken of those figures, the direction is clear: the government deliberately chose to lower the entry barrier, and the zero-fee position has held since August 15, 2022.

The practical implications of this change operate on three levels.

First level: government-side costs have disappeared, but not all costs have disappeared. The spending has shifted to the services side: IRH service fees, SII testing fees, translation and localisation fees, notarisation and legalisation fees, product liability insurance, and the preparation of clinical evaluations (see Part 36 of this guide). A budget that assumes a zero total cost because the government charges nothing will be wrong in the other direction.

Second level: the provisions remain, so fees can be restored without amending the law. Section 22 of the Law and Regulation 3(a)(11) together form a complete legal basis for charging. If the administration decides to restore fees, it only needs to adjust the administrative position; no parliamentary process is required. This is an assumption risk that belongs in every budget model.

Third level: the non-refund rule in Regulation 11 still matters. Even though no fees are currently charged, if fees were restored in the future, the rules that fees for rejected incomplete applications are not refunded, and that resubmission is barred for 1 month, would still exist in the text. Getting completeness right the first time remains the cost-optimal strategy regardless of the fee level.

The declaration route deserves a specific note in the budget. Because it is explicitly fee-free, the entire marginal cost of using it sits on the services side: preparing the declaration, assembling the supporting certificates, and managing the communication with the authorities through the IRH. Zero fees also change the economics of submission readiness. Because the government charges nothing for filing, the cost of a rejected application is measured in time rather than in money. The completeness self-check recommended below is therefore not bureaucratic caution but direct schedule protection, and quotations for the service-side items should be collected early enough to be compared rather than simply accepted.

4. Practical recommendations

• Model the budget as zero government fees plus service-side costs. Enter 0 on the government side and actual quotations on the services side.
• Run a sensitivity analysis for fee restoration. In multi-year budgets, perform one stress test under a restored-fee scenario (practical estimate).
• Check the current position before submitting. Confirm through the IRH with AMAR that the current fee is still zero; do not rely on older reference material.
• Do the completeness self-check first. Zero fees do not mean zero cost: the price of a rejection is time and a place at the back of the queue.

5. Verification checklist

• □ The current government fee position has been confirmed (no fees for registration / changes / renewals since August 15, 2022)
• □ The budget model has been built on a basis of 0 government-side plus quoted service-side costs
• □ A sensitivity analysis for a restored-fee scenario has been performed (practical estimate)
• □ The current position has been confirmed with AMAR through the IRH; older material has not been reused
• □ A completeness self-check process is in place to avoid a rejection under Regulation 11
• □ The historical figure (NIS 1,200 per item) has not been mistakenly applied to current budgets

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