Medical Equipment Regulations 5773-2013: Overview of 25 Articles

1. Key takeaways

The Medical Equipment Regulations (Registration of Medical Equipment in the Register and Renewal thereof), 5773-2013, were published on 12 June 2013, entered into force 30 days after publication under Section 25, comprise 25 articles, and were last amended on 10 May 2022. What actually forms the threshold for a submission are six articles: Section 3 (application elements), Section 5 (120-day decision period), Section 12 (validity period), Section 19 (manufacturing conditions, ISO 13485), Section 20 (storage and transport conditions, ISO 9001) and Section 23 (labelling in three languages). The remaining articles are mostly procedural or record-keeping duties, but Section 11 – outright rejection of an incomplete application – is the provision most likely to cause substantive delay, because its consequences include a 1-month bar on resubmitting the same application.

• Regulations 5773-2013: published 12 June 2013, in force 30 days later, 25 articles, last amended 10 May 2022.
• Section 5 sets a 120-day decision period for the Director.
• Section 19 requires ISO 13485 for manufacturing; Section 20 requires ISO 9001 for storage and transport.
• Section 23 requires labels in three languages.
• Section 11 allows rejection of an incomplete application without reasons, with a 1-month refiling bar.

2. Legal basis

The regulations are made under specific enabling provisions of the parent law, and their own numbering is the reference for every deadline discussed in this article. A citation difference exists in part of the secondary literature, which is noted in the table below.

3. Expert insights

Regrouping the 25 articles by whom they bind is more useful than memorising them by number:

Section 11 deserves a separate warning: where an application is incomplete, the Director shall reject it without stating reasons, the fee is not refunded, the same application may not be resubmitted for 1 month from the notice of rejection, and after two rejections for incompleteness a further submission requires the Director’s written approval; however, resubmission within 6 months of the rejection notice attracts no additional fee. This is the hardest procedural provision in Israeli filing – the price of format and completeness problems here far exceeds the price of technical problems.

Seen as a whole, the distribution of duties across the eight groups explains much of what goes wrong in practice. The applicant-side articles concentrate the risk at the moment of filing, where the completeness standard of Section 3(a) meets the rejection mechanism of Section 11; the Director-side articles concentrate the timeline, so a company that plans around the 120-day decision period and the certificate issuance periods can build a reliable launch calendar; and the holder-side articles run for the whole life of the registration, from labelling and distribution records through change notifications to renewal. A submission project that assigns each group to a named owner – applicant, regulator-facing, and holder-side – converts the 25 articles from a legal text into an operating checklist.

4. Practical recommendations

• Build a responsibility matrix by group: map the 25 articles onto the manufacturer, the IRH and the importer so that no duty falls between chairs.
• Front-load the completeness self-check: before filing, tick off the 13 elements of Section 3(a) one by one and eliminate the Section 11 risk before submission.
• Keep a separate deadlines table: the periods in Sections 5, 8, 12 and 16 differ from one another; enter them all in one schedule with reminders.
• Track amendments to the regulations: the regulations were last amended in 2022, and AMAR’s subsequent reforms are implemented mainly through REG procedural documents, so both must be tracked together.

5. Verification checklist

• □ The completeness self-check against the 13 elements of Section 3(a) has been completed
• □ The manufacturer’s ISO 13485 certificate (Section 19) and the storage provider’s ISO 9001 certificate (Section 20) are valid
• □ Labelling complies with the three-language requirement of Section 23 or an exemption has been obtained
• □ Distribution records are kept for at least the 3 years required by Section 24
• □ The deadlines in Sections 5, 8, 12 and 16 have been entered in the schedule
• □ A contingency plan for an incompleteness rejection exists (alternatives during the 1-month cooling-off period)

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