ISO 9001 Storage and Transportation Conditions under Regulation 20

1. Key takeaways

Article 20 of the Israeli Regulations provides that the transportation and storage of devices must be carried out by an entity whose compliance with ISO 9001 has been confirmed by an agency recognised by the Director, and that holds a storage and transportation business licence under the Business Licensing Law, 5728-1968. This is precisely the regulatory source of the familiar practice requirement that the IRH and the importer must hold ISO 9001 — it flows from the storage and transportation obligation, not from the qualification to hold a registration as such. At the same time, Article 3(a)(2) of the Regulations requires a storage and transportation conditions certificate confirming compliance with Article 20 to be submitted with the application.

• Article 20 regulates the storage and transportation activity rather than the status of the entity, so logistics may be outsourced provided the third party meets the same standard.
• ISO 9001 belongs to the storage and transport side (Article 20); ISO 13485 belongs to the production side (Article 19) — the two are not interchangeable.
• Storage and transportation conditions are a continuing obligation throughout the registration period, and breach is a ground for cancellation under the Law.
• The conditions certificate required by Article 3(a)(2) must be lodged with the application itself, covering the actual logistics provider.

2. Legal basis

The following table records the instruments and provisions behind the storage and transportation requirement, including the contrasting production-condition provision of Article 19.

3. Expert insights

Article 20 is often reduced to the shorthand that the importer must have ISO 9001, but its true object of regulation is the storage and transportation activity rather than the identity of the entity. That distinction produces three practical consequences.

Consequence one: storage and transport may be outsourced, but responsibility cannot be. Where the IRH or the importer does not itself have storage and transportation capability, third-party logistics may be engaged, but that third party must equally hold ISO 9001 confirmation and the business licence. At the time of application, the entity actually performing storage and transportation must be identified and its certificates submitted, because a mismatch between the declared and the actual logistics provider undermines the conditions certificate and will surface at the first inspection.

Consequence two: the division of labour between ISO 9001 and ISO 13485 is clear-cut. The production side is assessed under ISO 13485 (Article 19) and the storage and transport side under ISO 9001 (Article 20). Using an ISO 13485 certificate to satisfy Article 20 is not appropriate, and neither is the reverse. GRZAN checks these two certificates separately when reviewing IRH qualifications, precisely because substitution attempts are common and always resolve into findings.

Consequence three: storage and transportation conditions are a continuing obligation during the registration period. Article 7(a)(7) of the Law empowers the Director to prescribe transportation and storage conditions, and breach of the conditions of Article 7(a) is a ground for cancellation under Article 9(a)(3) of the Law. For devices with special requirements such as cold chain, protection from light and moisture control, keeping compliance records of the storage and transportation conditions is especially important, because these are exactly the records an inspection will ask to see.

Finally, a change of logistics provider is itself a notifiable event: under Article 15 of the Regulations, changes in the storage and transportation entity must be communicated to the Director, so provider switches should be planned with that notification step in view rather than executed silently between renewals.

4. Practical recommendations

• Identify the actual storage and transportation entity. Determine before the application who will perform storage and transportation, and verify that entity’s ISO 9001 confirmation and business licence.
• Ensure the certificate scope includes the storage and transport activities. The scope of certification of the ISO 9001 certificate must include descriptions of storage and/or transportation activities, not merely generic trading or services.
• Put special storage conditions in writing. Cold chain, light protection, moisture control and similar requirements should be written into the logistics agreement, with temperature and environmental monitoring records retained, because these records are the only practical proof that the written conditions are actually being met on every shipment, not merely on the audit day.
• Treat a change of provider as a change procedure. A change of the storage and transportation entity is a change that must be notified to the Director (Article 15 of the Regulations), so build the notification into the transition plan.

5. Verification checklist

• □ The actual storage and transportation entity has been identified (IRH-operated or third-party logistics)
• □ The entity’s ISO 9001 confirmation is within its validity period and its scope covers the storage and transport activities
• □ The entity holds a storage and transportation business licence under the Business Licensing Law
• □ The storage and transportation conditions certificate has been submitted with the application under Article 3(a)(2)
• □ Special storage requirements (cold chain and similar) have been documented in writing and monitoring records are retained
• □ A notification process for changes of the storage and transportation entity has been established (Article 15 of the Regulations)

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