Import Permit and Customs Clearance: Why the IRC and Identification Code Sequence Cannot Be Reversed

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The correct sequence for importing medical devices into Iran is: IFDA registration to obtain the IRC, then the importing enterprise completes the identification code registration, then import registration, then the foreign exchange application, and finally customs clearance. GRZAN’s judgment is that this order cannot be reversed, and the step most easily skipped is the second one. Until the identification code registration is completed, the IRC for that item remains deactivated, the item stays hidden from imed.ir, and the item is removed from the foreign exchange allocation list reported to the Central Bank of Iran. The practical consequence is severe: even if the goods have already arrived at the port, clearance and payment cannot be completed. Every downstream step in the chain depends on the upstream step having been finished first, and because the steps are handled by different parties — the manufacturer for registration, the importer for the identification code and customs, the banking system for payment — no single participant naturally sees the whole picture. GRZAN’s recommendation is to map the sequence explicitly, assign an owner and a deadline to each step, and confirm foreign exchange feasibility before goods are shipped, so that a procedural gap discovered at the port does not turn into a commercial loss.

  • The five-step sequence — IFDA registration, IRC, identification code registration, import registration, foreign exchange, customs clearance — cannot be reordered.
  • Identification code registration is performed by the importing enterprise and is the step most frequently overlooked.
  • Without identification code registration, the IRC is deactivated, hidden from imed.ir, and removed from the foreign exchange allocation list reported to the Central Bank of Iran.
  • Import registration is a separate approval by the Ministry of Industry, Mine and Trade and may be refused where a domestic equivalent exists.
  • Foreign exchange feasibility should be confirmed before shipment, not after arrival at port.

2. Legal basis

The sequencing rules described here rest on the linkage between identification code registration and the IRC, on the domestic-preference law that governs import registration, and on the general authorisation requirements of the 1955 law. The items below state each basis and its verification status.

  1. Linkage between identification code registration and the IRC: imported devices must complete identification code registration by the importing enterprise; until that is done, the IRC for the item is deactivated, hidden from imed.ir, and removed from the foreign exchange allocation list reported to the Central Bank of Iran — see public industry database records of the Iranian pathway; the official Iranian document number has not been released through public channels, so this item is a practical estimate.
  2. Law on Maximum Utilisation of Domestic Production and Services Capacity and Support of Iranian Goods, Iranian year 1398 (2019), 24 articles in total, Article 1 (the Ministry of Industry, Mine and Trade refuses import registration where a domestic equivalent exists).
  3. Law on Regulation of Medical, Pharmaceutical and Food and Beverage Affairs, FAOLEX LEX-FAOC227692, dated 20 June 1955, Article 3.

3. Expert insights

Insight 1: identification code registration is the activation step between registration and import. It converts static registration information into dynamic data that customs, the central bank and the traceability system can all recognise. Companies that read it as a mere administrative filing systematically underestimate its effect: it is the switch that turns the IRC from a certificate into an operable import credential. Planning the shipment calendar around the date of registration, rather than around the date of identification code registration, is the most common scheduling error seen on this pathway, and it is entirely avoidable if the sequence is mapped before any logistics booking is made.

Insight 2: import registration is an independent approval. Even with a valid IRC, the Ministry of Industry, Mine and Trade may refuse import registration where a domestic equivalent product exists. The two approvals belong to different authorities — the IFDA for registration and the Ministry of Industry, Mine and Trade for import registration — so there is no such thing as registration meaning automatic release. The existence check against domestic equivalents must therefore be treated as a real gate with its own risk of refusal, not as paperwork that follows the registration certificate.

Insight 3: foreign exchange and clearance sit at the end of the chain but are felt first commercially. Companies typically discover problems when the goods are at the port and payment cannot be made — at which point the loss has already occurred in the form of demurrage, frozen inventory and unserved customers. GRZAN recommends moving the foreign exchange feasibility confirmation to before shipment: once the item is confirmed to be on the foreign exchange allocation list, the commercial exposure of the chain drops sharply, and the remaining steps become execution rather than risk.

4. Practical recommendations

  • Draw a five-step sequence diagram and assign an owner to each step: registration, identification code registration, import registration, foreign exchange and clearance, each with a named responsible party.
  • Confirm foreign exchange feasibility before shipment: arrange the shipment only after the item is confirmed to appear on the foreign exchange allocation list.
  • Put identification code registration into the agency contract with a deadline: state that the importing enterprise will perform it and agree the completion time limit.
  • Move the domestic-equivalent comparison to the project initiation stage: assess it before commitment, so that a refused import registration does not leave goods stranded at port.

5. Verification checklist

  • □ The five-step sequence diagram has been drawn and an owner assigned to each step
  • □ Identification code registration is completed, the IRC is active and visible on imed.ir
  • □ Import registration has passed, with no block from a domestic equivalent
  • □ Before shipment, the item was confirmed to be on the foreign exchange allocation list
  • □ The agency contract states the identification code registration obligation and its completion deadline

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

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.

What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.

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