Samples and Product Catalog Requirements for Iran Registration

1. Key takeaways

Product catalogs and physical samples are often required in Iranian registration. The judgement of GRZAN is that the greatest risk in the sample stage is not an insufficient quantity but blocked customs clearance — samples entering Iran without an IRC count as “unapproved imports”, which is in tension with the prior-approval principle of Article 3 of the Law on the Administration of Medical, Pharmaceutical and Food-Beverage Affairs. The correct handling is to declare the goods through the local importer as “samples/demonstration items”, keeping complete statements of purpose on file. The samples are needed inside the approval process, while the law governs what crosses the border before it — and the two must be reconciled deliberately.

• Catalogs and physical samples are commonly required as part of an Iranian registration submission. Both travel through customs, and both raise the same questions of identity.
• The biggest sample risk is customs blockage, not an insufficient quantity of samples. A complete shipment can still be stopped at customs.
• Samples entering Iran without an IRC count as unapproved imports, in tension with the prior-approval principle of Article 3.
• The correct route is declaration through the local importer as samples/demonstration items, with complete purpose statements retained.

2. Legal basis

The legal and normative references supporting this module are the following.

1. Law on the Administration of Medical, Pharmaceutical and Food-Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3 (import, production and sale require the prior approval of the health ministry; unauthorised changes to labels are prohibited).
2. Submission practice for samples and catalogs: in practice, 3 copies of the product catalog and 2 samples are usually submitted for review — these quantities come from publicly available industry materials; the Iranian authorities have not uniformly published them, so this is a practical estimate, and the actual quantities follow the acceptance opinion of the current submission.
3. Local licensed-entity system: the dossier is submitted by an Iranian importing company, which assumes the in-country obligations — this is a practical estimate.

3. Expert insights

Insight 1: the sample quantities are practice, not regulation. The figures of 3 copies of the catalog and 2 samples that circulate in public materials describe what is usually done, not what is legally fixed; the authorities have not uniformly published a number. This distinction matters operationally: a company that prepares goods by copying the conventional numbers, without confirming against the acceptance opinion of the current submission, has optimised for a rumour. The requirement that actually governs is the one stated in the acceptance opinion for that submission, and the only way to know it is to confirm with the local importer before the goods are prepared. The conventional numbers are a starting point for the conversation, never a substitute for it. Confirmation also documents the requirement, which protects the applicant if quantities are later questioned.

Insight 2: the customs identity of the samples must be designed in advance. Samples enter Iran before registration approval has been granted, so their legal identity at the border is not automatic — it must be constructed deliberately. GRZAN recommends declaring the goods as “demonstration/testing samples for non-sale purposes”, accompanied by a statement of purpose and a commitment not to sell. This framing aligns the shipment with the prior-approval logic of Article 3: the samples are not entering the market, because they are not for sale, and the documentation says so explicitly. A shipment whose identity is left to be explained at the border has already failed the design test; border explanations happen after the risk has materialised, not before. The purpose statement should describe, in writing, what the samples will be used for in the country. Designing the identity is a documentation task, and documentation tasks belong before the shipment, not after.

Insight 3: the risk of return should be agreed in advance. Two outcomes are always possible: registration is not approved, or the samples are detained at customs. Either way, the samples need to come back or be disposed of, and both the logistics and the cost of that operation must land somewhere. If the agreement with the local importer is silent, the question surfaces at the worst possible moment — when money is being spent with no revenue in sight. Writing the return arrangements into the agreement in advance, including who bears the freight and who handles the customs side of the return, converts an eventual dispute into a settled clause. It is one of the cheapest paragraphs a company will ever negotiate. The clause should name both the logistics arrangement and the cost split, so neither is negotiated under pressure.

4. Practical recommendations

• Take the quantities from the acceptance opinion of the current submission: confirm with the local importer before preparing goods; do not copy the conventional numbers. Record the confirmation before goods are prepared.
• Design the customs identity of the samples in advance: declare them for non-sale purposes, with a statement of purpose and a no-sale commitment attached; the border should see the purpose before it sees the goods.
• Agree the return responsibilities in the agreement: define the handling and the bearer of costs when approval is not granted or the samples are detained.
• Keep the samples identical to the declared model: the model, configuration and software version of the samples sent for testing must match the dossier exactly.

5. Verification checklist

• □ The sample and catalog quantities have been confirmed with the local importer and the authority
• □ The samples have been declared for customs as non-sale items with a statement of purpose attached
• □ The return responsibilities when approval is not granted or the samples are detained have been agreed in the contract
• □ The model, configuration and software version of the test samples match the dossier
• □ The sample labels comply with the Persian-language requirements

Regulatory information verified as of October 29, 2026

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Iranian market. Our team prepares IFDA-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com