Legal Liability Boundaries of the Iranian Authorised Representative Across the Full Lifecycle

1. Key takeaways

The authorised representative in Iran carries a complete chain of responsibility running from registration, through import, to market supervision: submitting the dossier, holding the registration and the import licence, completing the identification code registration, executing vigilance and recall actions, and cooperating with market surveillance. GRZAN’s judgment is that concentrating responsibility in the local entity is the deliberate design of the Iranian system — it keeps a domestically reachable party in front of the regulator at every stage. However, this does not mean the foreign manufacturer can walk away free of consequences. Regulatory responsibility and contractual responsibility are two separate layers: the former points at the local entity, while the latter can reach back to the manufacturer through the agency agreement. Companies that understand only the first layer are exposed on the second. The agency contract is where the two layers meet, and it is also where the manufacturer can — and should — allocate responsibilities by cause, define notification deadlines, and convert the statutory duties of the representative into concrete, monitorable obligations with named owners and time limits. Treating the contract as a licensing formality leaves the manufacturer carrying unpriced risks throughout the product’s life on the Iranian market.

• The authorised representative’s duties cover the full lifecycle: dossier submission, holding the registration and import licence, identification code registration, vigilance and recall execution, and market surveillance cooperation.
• Regulatory responsibility points at the local entity; contractual responsibility can reach the manufacturer through the agency agreement.
• The agency contract and the undertaking letter must be consularised by an Iranian embassy or consulate abroad.
• Liability allocation in the contract should distinguish defects of the product from operational errors of the agent.
• The contract should oblige the agent to forward any notice from the competent authority to the manufacturer within an agreed deadline.

2. Legal basis

The duties of the local entity derive from the licence-holder system, the consularisation requirement for agency documents, and the penalty provisions of the 1955 law. The items below summarise each basis and its verification status.

1. Local entity obligations: submitting the dossier, holding the registration or import licence, and bearing subsequent in-country obligations including post-market supervision — see public industry sources; the official Iranian document number has not been released through public channels, so this item is a practical estimate.
2. The agency contract and the undertaking letter must be consularised by an Iranian embassy or consulate abroad — see public industry sources; this is a practical estimate.
3. Law on Regulation of Medical, Pharmaceutical and Food and Beverage Affairs, FAOLEX LEX-FAOC227692, dated 20 June 1955, Article 3 and Article 11 (penalties).

3. Expert insights

Insight 1: the chain of responsibility covers the full lifecycle. Many companies assume the agent’s job ends once the certificate is obtained. In practice, identification code registration, foreign exchange applications, vigilance reporting, recall execution and cooperation with market surveillance all fall within the agent’s scope of responsibility. If the contract only says that the agent will handle the registration, the later obligations fall into a contractual no-man’s land: nobody is contractually obliged to perform them, yet the product cannot stay lawfully on the market without them. The corrective is simple but requires discipline — enumerate the lifecycle duties one by one in the contract, so that each statutory duty of the representative is mirrored by a contractual duty with a deadline and a consequence for non-performance.

Insight 2: consularisation of the contract gives the terms practical enforceability. Once the agency contract and the undertaking letter have been legalised by an Iranian embassy or consulate abroad, their legal standing inside Iran becomes considerably firmer. In a dispute, an uncertified contract carries weaker evidentiary weight, and the manufacturer may find that clauses it negotiated carefully are treated as difficult to prove. Consularisation is a procedural step rather than a substantive one, but it is precisely the kind of step that determines whether the negotiated allocation of duties survives contact with an Iranian authority or court.

Insight 3: the penalties in Article 11 are the real pressure behind liability allocation. The 1955 law provides for fines and imprisonment. Although the regulator’s target is first of all the local entity, a manufacturer that promises in the contract to share penalties faces genuine financial and reputational exposure. Liability allocation clauses should therefore distinguish two situations: harm caused by a defect of the product and harm caused by the agent’s operational errors. Collapsing the two into a single indemnity makes the manufacturer an insurer of the agent’s conduct; separating them keeps each party accountable for the risks it actually controls.

4. Practical recommendations

• Enumerate the contract duties by lifecycle stage: registration, identification code registration, foreign exchange, vigilance, recall and market surveillance cooperation, each written out individually with its own requirements.
• Complete consularisation: ensure the agency contract and the undertaking letter are legalised by an Iranian embassy or consulate abroad before operations begin.
• Allocate liability by cause: agree separately on responsibility for product defects and responsibility for the agent’s operational errors, so that neither party insures the other’s conduct.
• Set an information notification obligation: require the agent to forward any notice received from the competent authority to the manufacturer within the deadline agreed in the contract.

5. Verification checklist

• □ The contract lists the agent’s duties item by item across the lifecycle
• □ The agency contract and the undertaking letter have completed consularisation at an Iranian embassy or consulate abroad
• □ Liability allocation distinguishes causes arising from product defects from causes arising from the agent’s operational errors
• □ A notification obligation and deadline are in place for notices from the competent authority
• □ The manufacturer’s mode of cooperation in vigilance and recall actions is clearly defined

Regulatory information verified as of 29 October 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 coordinates local import arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com