Applicant Eligibility: Local Authorised Representative Requirements in Iran

1. Key takeaways

In Iran, a foreign manufacturer cannot hold a medical device registration in its own name. The system requires a locally registered Iranian company to act as authorised representative and/or importer: that entity submits the dossier, holds the registration or import licence, and bears the in-country obligations. GRZAN’s assessment is that this is not a formality but a design for the allocation of responsibility — Iran concentrates the entire legal liability for a product within its territory on the local entity, so that the regulator can always reach a responsible party. Every instrument the regulator might need to pull, from the registration file to the vigilance record, sits with an addressable Iranian company rather than with an offshore manufacturer beyond practical enforcement reach. The direct consequence for strategy is that choosing the authorised representative is the decision carrying the highest risk weight in an Iranian project. The representative determines who controls the registration asset, who answers deficiency letters, and who the company must negotiate with if the commercial relationship sours while the registration stands in the representative’s name. Understanding the appointment as a delegation of legal standing, rather than as a sales channel agreement, is what separates well-structured Iran market entries from ones that later require painful restructuring. The arrangement also shapes negotiation dynamics: because the registration asset sits with the local entity, the balance of leverage in the relationship shifts over time toward whichever party can walk away with the asset, and the contract is the only instrument that settles that question in advance. Companies should therefore enter negotiations with a clear position on asset ownership before discussing prices and volumes, because the commercial terms are easy to renegotiate and the ownership terms are not.

2. Legal basis

1. Local licence-holding requirement: a foreign manufacturer must designate a legally registered Iranian company as authorised representative and/or importer, which submits the dossier and holds the registration or import licence — as recorded in public industry databases covering the Iranian pathway; no official Iranian document number has been published through open channels, so this is a practical estimate. The requirement should be read together with the foundational law’s prior-approval principle: the local holder is the party through which approval is sought and against which enforcement would run.
2. The Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3 (import and sale require approval).
3. The Law on Maximum Utilisation of Domestic Production and Service Capacity and Support of Iranian Goods, Iranian calendar year 1398 (2019), comprising 24 articles, Article 1 (import registration is not granted where a domestic equivalent product exists).

3. Expert insights

Insight one: concentrated responsibility creates agent risk. Registration, IRC, identification code, foreign exchange and customs clearance all attach to the same local entity. If that entity performs poorly or a dispute arises, the foreign manufacturer has practically no alternative route inside Iran. GRZAN recommends treating “ownership of the IRC and the registration” as a core contract clause, not as a point left to the agent’s default position. Whoever holds the code holds the market position, and the contract is the only place where that holding can be defined before it matters. Agent risk also has a quiet variant: an agent who performs adequately for years and then changes ownership, management or financial condition can change the risk profile of the entire arrangement overnight, which is why the backup entity should be kept warm even when the primary relationship is good.

Insight two: the qualification of a local entity is not “having a business licence”. In actual operations, the authorities examine the importer’s business scope, warehousing conditions and quality officer arrangements. An under-qualified agent leaves the submission stuck at the formal examination stage, before any technical merit of the product is even considered. Diligence on these points before appointment therefore protects the timeline, not merely the legal position, and the cost of that diligence is trivial compared with the cost of a stalled file. The examination of these points is factual rather than documentary, so a site visit or a reference call to an existing principal of the agent is often more informative than any certificate the agent can produce.

Insight three: import registration and entity qualification are two independent review lines. Even if the local entity is fully qualified, import registration is still refused where an Iranian-made equivalent of the product exists. Beyond selecting the agent, the company must in parallel complete an “Iranian-made equivalent product comparison” — the two matters are not substitutes for each other. A perfect agent cannot cure a blocked category, and an open category cannot cure an unqualified agent; both gates must be passed independently before a project can be considered viable. The comparison should be documented with the same care as the agent selection, because the two documents together are what the project relies on if the category question is ever raised by the authority.

4. Practical recommendations

1. Run due diligence in three steps: verify business registration and scope → verify warehousing and quality officer arrangements → verify past agency brands and performance record, in that order, with each verification date-stamped so the file shows when the diligence was current.
2. State four ownership points in the contract: ownership of the registration and IRC, ownership of the dossier and translations, the mechanism for replacing the entity on breach, and the handover obligations on termination.
3. Avoid unconditional exclusivity: exclusivity clauses should be tied to minimum purchase volumes or market investment indicators and should carry a defined term.
4. Keep a dual-entity backup: for strategic product lines, engage a second qualified importer in advance as a backup, so a replacement path exists before it is needed.

5. Verification checklist

• □ Business registration and business scope of the local entity have been verified
• □ Warehousing conditions and quality officer arrangements have been verified
• □ The contract clearly states ownership of the registration and IRC and the entity replacement mechanism
• □ Exclusivity clauses are tied to quantitative indicators and carry a set term
• □ The Iranian-made equivalent product comparison has been completed in parallel, ruling out a block on import registration

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