Business Licensing Law in Israel: Manufacturing, Storage and Transport Licences

1. Key takeaways

Israeli device compliance contains a cross-cutting obligation that is not device regulation but applies to devices: the Business Licensing Law, 5728-1968. Regulation 19 of the Regulations requires local manufacturing in Israel to hold a manufacturing business licence under that Law; Regulation 20 requires storage and transport parties to hold a storage and transport business licence. This obligation is administered by local authorities in Israel and sits in a system entirely separate from AMAR, yet it is reviewed together with the registration dossier at the time of filing.

• Local manufacturing in Israel requires both ISO 13485 and a manufacturing business licence under the Business Licensing Law.
• Storage and transport parties require both ISO 9001 confirmation and a storage and transport business licence.
• The licence number and its expiry date must be declared with the registration application (Regulation 3(a)(1)).
• Licensing is handled by local authorities, covering fire, environmental, health and zoning aspects, and is unrelated to device technical review.
• Because the licence has an expiry date, it must join the expiry dashboard alongside the other certificates.
• The licence review covers fire, environmental, health and zoning dimensions of the premises, not device performance.

2. Legal basis

The cross-cutting obligation originates in a general commercial statute rather than in device-specific law, and it is pulled into the device regime through Regulations 19 and 20 of the Medical Equipment Regulations, 5773-2013. The table below sets out the instruments and provisions. 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

What makes this cross-cutting obligation distinctive is its authority and its review timing. The business licence is issued by local authorities in Israel, and the review covers fire safety, environmental protection, health and zoning of the premises. None of these dimensions has anything to do with the technical review of a device. Nevertheless, Regulation 3(a)(1) requires the business licence number and its expiry date to be declared with the registration application, which turns this local commercial licence into a formal element of the device registration dossier.

Three practical consequences follow from this arrangement.

First, local manufacturers need two sets of licences. An entity producing within Israel must satisfy both ISO 13485 (the quality system) and the business licence (premises compliance). Neither can be dispensed with, and because the two processes are handled independently, their timelines do not affect each other and can proceed in parallel.

Second, outsourcing storage and transport requires checking the outsourcing party’s licence. Where third-party logistics is used, the logistics provider must simultaneously hold ISO 9001 confirmation and the storage and transport business licence. When GRZAN audits the credentials of a storage and transport party, these two documents are treated as parallel, equally mandatory requirements rather than as alternatives.

Third, the licence has a limited term and must join the expiry dashboard. The business licence number and its expiry date are declared with the application, and failure to renew before expiry can affect the registration status. Together with the ISO certificate, the registration certificate and the reference-country certificate, it constitutes the fourth certificate in the set that must be tracked continuously.

The broader lesson is that Israeli market entry is not a single regulatory track. A company that completes the AMAR file perfectly can still face distribution problems if the warehouse operator lacks a valid local licence, because the two systems intersect at the moment of application and again whenever the file is examined.

The timing point matters as much as the substance. Because the business licence is reviewed by local authorities on their own schedule and the device registration is reviewed by AMAR on its own, neither process can substitute for the other, and progress in one does not excuse the other. Companies planning a site or a local production line should therefore treat the two licences as parallel work streams with independent owners, rather than as a single approval package handled through one contact. In GRZAN’s experience, the practical failure mode is not refusal but silence: a file that is complete for AMAR is held up because one local document expired quietly in the background.

4. Practical recommendations

• Verify both sets of certificates. For storage and transport: ISO 9001 confirmation plus the business licence. For local manufacturing: ISO 13485 plus the business licence.
• Audit outsourcing credentials in parallel. Verify the third-party logistics provider’s ISO 9001 and storage and transport business licence together, not separately.
• Put the business licence on the expiry dashboard. Manage it in the same view as the registration, the import permit and the reference-country certificate.
• Assess site changes early. A change of storage or manufacturing premises can trigger both a new business licence process and a registration change; schedule both.

5. Verification checklist

• □ The storage and transport party holds a storage and transport business licence under the Business Licensing Law (Regulation 20)
• □ The local Israeli manufacturing entity holds a manufacturing business licence (Regulation 19)
• □ The business licence number and expiry date have been entered in the application form under Regulation 3(a)(1)
• □ For any third-party logistics provider, ISO 9001 and the business licence have been verified
• □ The business licence is included in the four-certificate expiry dashboard
• □ The impact of site changes on the business licence and on the registration change has been assessed

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