ISIRI Mandatory Standard Checklist for Medical Devices in Iran

1. Key takeaways

Completing one round of ISIRI mandatory standard comparison before submission is the most cost-effective single piece of work in an Iranian project. It is also among the few tasks whose cost is measured in days and whose consequence is measured in months. The judgement of GRZAN is that whether this step is done directly determines whether a second sample submission is needed later. The core of the comparison is not “whether an ISIRI standard exists” but the adoption relationship — standards adopted identically (IDT) allow international test reports to be carried over, while standards adopted with modifications (MOD) require supplementary testing of the differing clauses. Read this way, the comparison is less a formality than a scoping decision for the entire test plan.

• A pre-submission ISIRI mandatory standard comparison is the highest-value single task in an Iranian registration project.
• Skipping or rushing the comparison can directly result in a second sample submission later, with all the cost and delay that implies.
• The decisive question is not the existence of an ISIRI standard but the adoption relationship attached to it. The two questions look similar and lead to very different workloads.
• IDT standards allow international reports to be reused; MOD standards require additional testing of the clauses that differ. A second sample submission is exactly the outcome the comparison exists to prevent.

2. Legal basis

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

1. The ISIRI national standard system: the Institute of Standards and Industrial Research of Iran is responsible for developing national standards and mandatory certification, and many of its standards are identical or modified adoptions of international standards — the specific standard numbers must be checked item by item; this is a practical estimate.
2. Acceptance of international standards: test reports issued under international standards such as ISO and IEC are usually accepted, but where a corresponding mandatory ISIRI standard exists, conformity is judged against the ISIRI standard — this is a practical estimate.
3. Law on the Administration of Medical, Pharmaceutical and Food-Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3.

3. Expert insights

Insight 1: the adoption marker determines the workload. An IDT (identical) adoption means the technical content matches the international standard, so a report issued against that international standard can directly support conformity. An MOD (modified) adoption means technical differences exist, and each differing clause must be tested in addition to the international report. Where the adoption is not equivalent, full testing to the ISIRI standard is in practice required. The difference between these outcomes is enormous in cost and time, which is why GRZAN requires its checklist to state the adoption marker explicitly for every standard. Writing only “a standard exists” is not acceptable: it hides the single piece of information — IDT, MOD or not equivalent — that decides how much testing the project still owes. The marker is written on the face of the ISIRI standard, so obtaining it is cheap; discovering it late is the expensive outcome.

Insight 2: the mandatory list changes. ISIRI reviews and adjusts its mandatory lists, which means a comparison that was valid last year may be invalid this year: a standard may have been added, revised or moved onto the mandatory list since the last check. A checklist that carries no date cannot be trusted, because nobody can tell which version of the list it was drawn against. The checklist must therefore record the date of the check, and a review cycle must be set so the comparison is refreshed on a schedule rather than on memory. This costs almost nothing to maintain and protects the whole testing plan that was built on top of the comparison. A dated checklist also makes explicit which version of the list every testing decision was based on.

Insight 3: even without a corresponding standard there is a path. When a product category has no corresponding mandatory ISIRI standard, the situation is not a dead end. Reports may be issued under international standards, and the dossier should include a written statement that, after verification, no corresponding mandatory ISIRI standard exists. This statement should record the scope of the verification and the date on which it was performed. The document matters more than it may appear: it demonstrates to the reviewer that the absence of an ISIRI standard was checked and confirmed rather than assumed, and it stands in the dossier as a compliance document in its own right. In other words, the statement converts an absence into evidence, which is what a dossier needs rather than silence.

4. Practical recommendations

• Fix five columns in the checklist: product name, ISIRI standard number, adoption relationship (IDT/MOD/not equivalent), differing clauses, and handling conclusion. The five-column format keeps every row answerable.
• Record the check date and set a review cycle: GRZAN recommends re-verifying every 12 months, and the cycle belongs in the project calendar rather than in someone’s memory.
• Issue a written statement when no corresponding standard exists: state the scope, the databases and the date of the check, and attach the statement to the dossier.
• Finalise the test plan before samples are submitted: determine the test items from the differing clauses first, then submit samples, so that a second sample submission is avoided. The plan and the submission are thus decided in one motion rather than two.

5. Verification checklist

• □ The ISIRI mandatory standard check for the products under application has been completed and a five-column checklist has been issued
• □ The adoption relationship (IDT/MOD/not equivalent) has been marked for every standard
• □ The differing clauses of MOD items have been identified and incorporated into the test plan
• □ A written statement has been issued and attached to the dossier for cases with no corresponding standard
• □ The checklist has been dated and a 12-month review cycle has been set

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