ISIRI Mandatory Standards and International Standard Adoption in Iran

1. Key takeaways

The Iran Standards and Industrial Research Institute (ISIRI) is Iran’s national standards body. It develops and issues Iranian national standards and applies mandatory certification to certain product categories. GRZAN’s assessment is that the relationship between ISIRI standards and international standards is not a choice of one over the other, but a rule that where an ISIRI counterpart exists, ISIRI must be satisfied. The Iranian authorities generally accept test reports issued against international standards such as ISO and IEC, but when a mandatory ISIRI standard exists for a product category, the conformity determination is made against ISIRI. A pre-submission “ISIRI mandatory standard comparison” is therefore unavoidable. Skipping it does not usually fail the submission outright at first; instead it surfaces later as a deficiency letter demanding testing nobody budgeted for, or as a reviewer question about why the report covers a version of the requirements that differs from the Iranian text. Either outcome costs calendar time disproportionate to the effort the comparison would have taken. The comparison also has a commercial dimension: knowing the ISIRI position early tells the laboratory exactly which tests to run once, rather than twice, and that single fact often determines whether the testing phase of an Iranian project stays on schedule. The comparison is not a literature exercise: it produces a working document that drives the test plan, the laboratory quotation and the budget, and it is the first artefact a well-run Iranian project creates after the classification decision.

2. Legal basis

1. The ISIRI national standards system: the Iran Standards and Industrial Research Institute is responsible for national standard development and mandatory certification; Iran adopts international standards (ISO, IEC and others) through identical or modified adoption — the adoption relationships and the mandatory list are found in the catalogues published by ISIRI; specific standard numbers vary by product category and must be checked item by item, so this is a practical estimate. Because the catalogues are the authority’s own publication, they should be cited by retrieval date in the project record, so that a later change of the list does not invalidate the basis on which the tests were commissioned.
2. The Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3.
3. The Law on Maximum Utilisation of Domestic Production and Service Capacity and Support of Iranian Goods, adopted in Iranian calendar year 1398 (Gregorian 2019), comprising 24 articles, Article 1.

3. Expert insights

Insight one: the adoption relationship decides whether existing reports can be used directly. Many ISIRI standards adopt international standards identically or with modifications. Under identical adoption (IDT), ISO/IEC reports from international laboratories can generally support the file directly; under modified adoption (MOD), the clauses that differ require supplementary testing. GRZAN requires project teams to pull the adoption status of the corresponding ISIRI standard before the test plan is finalised. This single check determines the shape of the entire test programme: under IDT the existing report package may stand almost as it is, while under MOD the differences become the centre of gravity of the plan and the main driver of its cost. Where the adoption status is recorded ambiguously, the differing clauses should be identified by direct comparison of the two texts, and the comparison itself should be kept in the project file.

Insight two: the mandatory list is dynamic. The list of mandatory ISIRI standards is adjusted over time, and the degree of compulsion differs across categories. Preparing a current submission against a list compiled a year ago produces one of two kinds of waste: “under-testing”, where a newly mandatory requirement is missed, or “over-testing”, where effort is spent on requirements no longer framed the same way. Both waste budget, and the first can stop a submission entirely, so the list must be re-pulled at the moment the test plan is frozen, not merely inherited from the last project. A mid-project change of the list is also a change-control event for the test plan, and the plan should state who re-checks the list when the submission date slips.

Insight three: standards policy interlocks with localisation policy. Article 1 of the Law on Maximum Utilisation of Domestic Production and Service Capacity requires priority for domestic products and services, and ISIRI standards are precisely the yardstick for judging “whether a domestic product meets the requirements”. A company planning to bypass import restrictions through local cooperative manufacturing must understand that the product still has to satisfy ISIRI standards — standards compliance is not relaxed because production takes place inside Iran. The same bench of requirements follows the product across borders of production site. For the authorities, the standard is the common language between imported and domestic products, which is precisely why it cannot be waived for either side.

4. Practical recommendations

1. Build an ISIRI mandatory standard check sheet: verify item by item for the product category, recording the standard number, the adoption relationship (IDT/MOD/nonequivalent) and the differing clauses, so the testing scope rests on a documented basis.
2. Fix the test plan before samples are shipped: determine before dispatch whether supplementary testing against ISIRI differing clauses is needed, avoiding a second round of sampling and its attendant delay.
3. Confirm laboratory qualifications in advance: confirm that the laboratory issuing the reports is accepted by the Iranian authorities (laboratories within the ILAC/IAF mutual recognition framework are the preferred choice).
4. Review the list annually: place the ISIRI mandatory list review into the annual compliance calendar, so category-level changes are caught between projects rather than during them.

5. Verification checklist

• □ The ISIRI mandatory standard comparison for the products to be submitted has been completed and issued as a written check sheet
• □ The adoption relationship (IDT/MOD/nonequivalent) and the differing clauses have been confirmed
• □ It has been confirmed that reports from the testing laboratory will be accepted
• □ The test plan covers the ISIRI differing clauses, with no second sampling round required
• □ The annual review of the ISIRI list has been entered into the compliance calendar

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 manages IFDA (Iran FDA) registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com