Persian Language Requirements for Medical Device Labelling in Iran

1. Key takeaways

Iran applies a Persian-first language regime to medical devices: labels, instructions for use and patient-facing materials for healthcare institutions require Persian content, and the foreign-language portions of technical documentation must be accompanied by certified Persian translations. GRZAN’s assessment is that language compliance in Iran is not a matter of “translation quality” but a compliance element — a missing or mistranslated item directly triggers rejection of the file, and because Article 3 expressly prohibits unauthorised alteration of the label, the room for repair afterwards is very small. A label that reaches the market with defective Persian wording cannot simply be corrected by the marketing department; it must pass through the formal change process, and the defective lot may already have attracted regulatory attention by then. The economics are therefore heavily weighted toward getting the language right before printing: the cost of a professional terminology system and a local review pass is a small fraction of the cost of a relabelling campaign, a resubmission, or a customs hold on goods whose packaging the reviewer cannot accept. Language should be planned as part of the regulatory strategy from the day the dossier structure is agreed, not appended at the artwork stage. The regime also has a practical front door: because the Persian text is the text the regulator and the user both read first, the quality of the Persian determines the quality of the first impression, and a file that reads well in Persian is reviewed with correspondingly fewer language-related queries. Teams should therefore budget for Persian work as a core line item — terminology, translation, local review and version control — rather than as an artwork afterthought, and should appoint one owner who is accountable for the consistency of all Persian output across the project.

2. Legal basis

1. The Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3 (unauthorised alteration of composition or labelling is prohibited; import and sale require approval).
2. Persian labelling and instructions requirements: Persian labels, instructions for use and patient materials are expected; foreign-language documents must be accompanied by certified Persian translations — as set out in public industry material; no official document number has been published through open channels, so this is a practical estimate. The expectation applies across the user-facing document set, and the certified translation is the instrument by which the authority links the foreign original to its Persian counterpart.
3. Nomenclature: the complete dossier uses the UMDNS nomenclature system — see the Iran entry in the World Health Organization overview of medical device nomenclature systems in WHO Member States.

3. Expert insights

Insight one: technical files may be bilingual, but labels must be Persian. The boundaries of the two requirements differ. Technical documentation may keep an English original with a Persian translation attached; labels and instructions for use must carry Persian as the user-facing language. Mixing the two into a single language strategy is a common error, and it fails in both directions at once: a Persian-only technical file is harder to review against the original evidence, while an English-facing label is not acceptable to the end user at all. Drawing the line explicitly in the project plan prevents the two workstreams from borrowing each other’s rules. A useful internal test is to ask, for each document, who reads it first: if the reader is the authority’s reviewer, an English original with a certified translation is the norm; if the reader is a clinician or a patient, Persian is the norm and translation is not a substitute.

Insight two: terminology consistency matters more than linguistic fluency. Iran uses the UMDNS nomenclature system, and Persian terms should align with the standard terms corresponding to the UMDNS codes. GRZAN requires project teams to build a “Chinese–English–Persian trilingual terminology table” and to enforce it across all documents, so that the same component never appears under two Persian spellings in the label and the instructions for use. Reviewers notice inconsistency quickly, and each noticed inconsistency costs credibility that the rest of the file must then spend effort recovering. The table should also record the UMDNS code beside each term, so the terminology system and the coding system stay aligned as the file grows.

Insight three: contraindication and warning content needs localised review. Content touching religious and cultural sensitivities — such as statements on ingredients of animal origin — must have its Persian wording reviewed locally; it cannot be translated literally. A literal rendering may be linguistically correct and locally unacceptable at the same time, and only a reviewer embedded in the local context can tell the difference before the text reaches the regulator or the market. Local review is a distinct step from translation review: the translator confirms the meaning, the local reviewer confirms the acceptability, and the two sign-offs should be recorded separately.

4. Practical recommendations

1. Build a trilingual terminology table: Chinese–English–Persian, covering all components, warnings and indication statements, and enforce its use across every document in the file.
2. Bring label finalisation under change management: once a label is finalised it falls under change control, and any modification must pass through the formal change channel.
3. Review sensitive content locally: statements touching ingredient origin, contraindications and religion-related wording are handed to an Iran-based reviewer for verification before release, and the reviewer’s comments are recorded together with the final text.
4. Keep translations traceable on file: retain the translation body’s qualification evidence and the version history of translated drafts, so they can be presented on inspection.

5. Verification checklist

• □ A Chinese–English–Persian trilingual terminology table has been built and is applied uniformly across all documents
• □ The Persian versions of labels and instructions for use have been finalised and brought under change management
• □ Certified Persian translations accompany the foreign-language originals of the technical documentation
• □ Sensitive content (ingredient origin, contraindications) has completed local review
• □ The translation body’s qualification evidence and translated draft versions are on file

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