Iran Medical Device Risk Classification: Classes A, B, C and D

1. Key takeaways

Iran applies a 4-class risk classification aligned with the GHTF (Global Harmonization Task Force) framework: Class A (low risk), Class B (moderate-low risk), Class C (moderate-high risk) and Class D (high risk). Classification is based on the manufacturer’s intended-use claims and the application field of the product, not on the product name. GRZAN’s assessment is that classification is the single most cost-effective up-front investment in an Iranian project. If the class is set incorrectly, the entire organisation of the subsequent dossier deviates from what the reviewer expects, and the cost of correction far exceeds the original investment, because every downstream document, from the clinical rationale to the labelling architecture, is built on the assumed class. A wrong class therefore does not create one error but a cascade of them, and the cascade is usually discovered late, when most of the budget has already been spent. Determining the class early, documenting the reasoning, and confirming it with the authority where the case sits near a boundary are inexpensive steps that protect the whole project. Companies that treat classification as an administrative formality tend to pay for that view repeatedly; companies that treat it as a strategic decision tend to move through review without structural rework. It is also worth noting that the four classes map onto review effort in a graduated way, so the class determines not only the substance of the dossier but the depth of scrutiny it will receive, and that depth is visible to the project team long before submission.

2. Legal basis

1. IMED classification submission rules: the framework is based on the GHTF four-class risk scheme, with review depth organised across the four tiers A/B/C/D. These rules are cited on the public pages of the Food and Drug Deputy of Iran University of Medical Sciences and of the IFDA General Directorate of Medical Equipment and Supplies; no official document number has been published through open channels, so this is a practical estimate.
2. Nomenclature: Iran accepts declarations of conformity under its own classification (the Iran Registration Code, IRC, system), the European Union classification, or the United States FDA classification, but the complete dossier must use UMDNS nomenclature — see the Iran entry in the World Health Organization overview of medical device nomenclature systems in WHO Member States, as cited in the classification documents published on imed.ir.
3. The Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3.

3. Expert insights

Insight one: four classification frames may coexist, but the dossier frame must be unified. The WHO nomenclature survey shows that Iran accepts any one of three declarations of conformity — its own classification, the EU classification, or the US FDA classification — yet the complete submission must be organised under UMDNS. This means a company can use an existing CE or FDA classification as the starting point of its argument, but the documents finally submitted must land on UMDNS codes. This is Iran’s distinctive dual-track requirement: “classification may be plural, nomenclature must be unified”. Teams that map their existing certificates onto UMDNS early avoid the last-minute scramble of reconciling three vocabularies while a submission deadline is running. The mapping work is mechanical but detail-sensitive: a single product family may span several UMDNS codes, and each code used in the final submission must be traceable back to the certificate or classification on which the conformity argument rests.

Insight two: the intended-use claim matters more than the product form. Classification looks at the use the manufacturer itself claims. The same device, claimed as “assisting diagnosis” versus claimed as “screening”, can fall into two adjacent classes. GRZAN recommends fixing the classification before the instructions for use are finalised, rather than drafting the instructions first and inferring the class backwards. The intended-use wording is the driver of the class, so the wording should be written with the class in mind, and any later change to that wording should trigger an immediate re-check of the classification conclusion. In practice this means the classification conversation and the labelling conversation are one conversation held twice, and keeping them synchronised spares the team from reconciling two documents that were never meant to diverge.

Insight three: classification disputes have a clear escalation path. For borderline cases, the correct course is to raise a pre-classification communication request with IFDA and obtain a determination from the medical device committee, instead of the company quietly “declaring downward”. The price of declaring downward is structural: the dossier is organised to the lower tier, and once the authority determines the higher class applies, the entire technical file must be redone. A documented pre-classification answer costs little, converts an open question into a closed one, and gives the project a defensible record if the class is later questioned. Where the committee’s answer is awaited, the project can proceed with everything that does not depend on the class, but no document should be finalised until the answer is on record.

4. Practical recommendations

1. Classify first: place the classification determination before technical documentation work and deliver it as a standalone deliverable with recorded reasoning, so every later document inherits a settled premise.
2. Prepare on three classification frames in parallel: prepare the domestic classification argument, the CE/FDA classification basis, and a UMDNS code mapping table at the same time, so no frame is reconstructed under deadline pressure.
3. Request pre-communication for borderline cases: for products that may sit on the B/C or C/D boundary, request pre-classification communication before formal submission and keep the determination on file as part of the project record.
4. Unify claim wording: the intended-use statements in the Chinese, English and Persian instructions for use must be identical, so that no language version can alter the classification determination after the fact.

5. Verification checklist

• □ An A/B/C/D determination has been made under the GHTF framework and the reasoning has been recorded in writing
• □ UMDNS code mapping has been completed, with a one-to-one match to product models
• □ A declaration of conformity has been issued against the EU classification or the US FDA classification
• □ The intended-use statements are identical across the three language versions of the instructions for use (Chinese/English/Persian)
• □ For borderline cases, a pre-classification opinion from the competent authority has been obtained and filed

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