Technical File Retention under the Declaration Route

1. Key takeaways

Under the Israeli declaration route, the technical file is a non-mandatory submission item, and Class I manufacturers are not required to provide an ISO 13485 certificate either, although they must submit a declaration of conformity with the requirements of that standard. This does not mean the technical file can be skipped. Article 3(a)(12) of the Regulations requires the applicant and the manufacturer to declare that complete and reliable information is provided, and the declaration route guidance goes further, expressly requiring the registration holder to hold all documents and certificates supporting the registration. The burden of proof therefore shifts from the moment of submission to the moment of a spot check.

• The declaration route waives the obligation to submit the technical file, not the obligation to prepare it to full depth.
• The registration holder is the party required to hold the supporting documents, so the manufacturer must hand over a complete file package to the IRH.
• Failure to produce documents during a spot check can lead not merely to a request for supplementation but to cancellation of the registration under Article 9(a)(3) of the Law.
• A written declaration of conformity with ISO 13485 requirements substitutes for the certificate itself for Class I devices on this route.

2. Legal basis

The obligations described above rest on the declaration route guidance and on the underlying Law and Regulations. The table records each instrument, its number and date, and the specific provisions relied on.

3. Expert insights

The design logic of the declaration route is to trade trust for speed: AMAR conducts no technical review and completes the registration entry within 48 hours, on the condition that the registration holder assumes the full compliance burden by legal declaration. This design shifts the risk from the regulator to the certificate-holding entity, and it moves the centre of gravity of the work away from assembling one submission package and towards being able to produce a complete package at any time, on demand.

Three practical corollaries follow from this design.

Corollary one: the technical file should still be prepared at full depth. What the declaration route exempts is the submission obligation, not the preparation obligation. GRZAN recommends preparing the file to the depth expected under the standard route, covering in particular risk management (ISO 14971), performance and safety testing, and the labeling and instructions for use. A file that exists only in outline will not withstand a spot check that asks for substantiation of the declarations made.

Corollary two: the holding entity is the IRH, while the preparing entity is the manufacturer. The declaration letter expressly requires the registration holder to hold all supporting documents. This means the manufacturer must deliver a complete technical file package to the IRH, and the IRH must have a genuine capability to store and retrieve it — a substantive selection criterion when choosing an IRH, not a formal clause. An IRH that cannot reliably hold and produce the file exposes the registration itself.

Corollary three: the consequences of failing a spot check are severe. Article 9(a)(3) of the Law lists the situation in which the holder breaches the conditions of Article 7(a) or fails to comply with instructions under Article 11 as a ground for cancellation of the registration. If the documents cannot be produced when the check arrives, the outcome is not limited to a request to supplement the file; it may directly result in the registration being cancelled, with all the market consequences that follow.

Taken together, these corollaries explain why experienced applicants treat the declaration route file with the same discipline as a submitted dossier: the difference is only when the file is examined, not whether it must exist in full.

4. Practical recommendations

• Build a technical file package held ready for inspection. Prepare it to the depth of the standard route, annotate each document with its version and the person responsible for updates, and apply this equally to products registered through the declaration route.
• Deliver the package to the IRH and sign a custody agreement. The agreement should specify the document inventory, the update frequency, the time limit for retrieval on request, and the handover arrangements when the relationship ends.
• Schedule retrieval drills. Run at least one simulated spot check per year to test whether the complete file set can be produced within 48 hours (practical estimate).
• Update the package whenever the product changes. Every change to the product must be reflected in the inspection-ready package, so that version inconsistencies never surface during a spot check.

5. Verification checklist

• □ A technical file package held ready for inspection has been prepared at full depth for declaration-route products
• □ The package covers risk management (ISO 14971), performance and safety testing, and labeling and instructions for use
• □ The package has been delivered to the IRH and a custody and handover agreement has been signed
• □ An annual retrieval drill mechanism is in place (48-hour response, practical estimate)
• □ Synchronized updating on change has been built into the change management process
• □ A written declaration of conformity with ISO 13485 requirements is ready (substituting for the certificate submission)

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