Domestic Equivalent Blocking of Medical Device Import Registration in Iran

1. Key takeaways

The second gate for imports into Iran is import registration, known in Persian as sabt-e sefaresh: whenever similar goods, equipment and materials already exist within the country, the Ministry of Industry, Mine and Trade will not process the registration. The judgment of GRZAN is that this gate more easily becomes the true breakpoint of a project than IFDA registration itself — a large number of companies discover that they cannot import only after they have obtained registration, at which point the sunk cost is already heavy. There are three realistic response paths: differentiated positioning argumentation, local cooperative production, and application for an exemption. The order of preference should be to argue differentiation first, because it carries the lowest cost and does not disturb the existing market layout.

• Article 1 of the 2019 law (24 articles in total) denies import registration when similar goods exist domestically, making the blocking test a project-critical check.
• Projects covered by the law must direct at least 51% of their costs to Iranian labor, materials and services.
• An exception where no domestic product or service truly exists requires approval by the entity’s highest responsible person plus the consent of the Ministry of Industry, Mine and Trade — a two-tier procedure with a long cycle.
• Clause A of Article 72 of the Seventh Development Plan requires a self-sufficiency mechanism for APIs, drugs, consumables and medical devices to be established by the end of plan year 1.
• The determination of similarity is made by function, performance and use, not by product name, which leaves room for a technical differentiation argument.
• The Iranian compliance chain has four links — IFDA registration, import registration, foreign exchange, customs clearance — and a project plan that covers only the first link is incomplete.
• Differentiation arguments must rest on quantified technical parameters, because descriptive claims will not survive scrutiny.
• Because the blocking decision is taken by the Ministry of Industry, Mine and Trade at the import registration stage, evidence prepared for IFDA registration alone does not address this gate.

2. Legal basis

The primary instrument is the Law on Maximum Utilization of the Country’s Production and Services Capacities in Support of Iranian Goods, adopted in Iranian year 1398 (2019), consisting of 24 articles. Article 1 provides that where similar products exist within the country, the Ministry of Industry, Mine and Trade will not register the corresponding imports. Projects subject to the law must ensure that at least 51% of project costs are directed to Iranian labor, materials and services. Where no domestic product or service genuinely exists, the exception requires approval by the highest responsible person of the entity and the consent of the Ministry of Industry, Mine and Trade, which makes the exemption route deliberately demanding.

The second instrument is clause A of Article 72 of Chapter 14 of the Seventh National Development Plan Law of the Islamic Republic of Iran, which requires a mechanism for raising self-sufficiency in active pharmaceutical ingredients, drugs, consumables and medical devices to be established no later than the end of plan year 1. The presence of a hard deadline confirms that the blocking policy is being actively institutionalised.

The statutory foundation of prior authorisation remains the Law Concerning Regulations of Medical, Laboratory, Pharmaceutical and Food and Beverage Affairs, recorded in FAOLEX as LEX-FAOC227692, dated 1955-06-20, Article 3.

3. Expert insights

Insight 1: the blocking occurs after registration, which is why it is so easily overlooked. The Iranian compliance chain runs from IFDA registration to import registration, then to foreign exchange allocation, and finally to customs clearance. Most corporate project plans cover only the first link. GRZAN requires that every Iranian project schedule explicitly includes all four links, because a registration certificate that cannot be converted into an importable shipment delivers no commercial value at all.

Insight 2: the determination of similarity leaves room for argumentation. A domestic equivalent is not judged by product name but by function, performance and use. If a company can demonstrate that its product differs from the Iranian-made product in key performance parameters, intended scope of application or technology generation, it may argue that the two do not constitute similar products. Such an argument must be supported by a technical parameter comparison table; descriptive claims without quantified parameters will not carry the case.

Insight 3: clause A of Article 72 means the blocking will continue to tighten. The plan law elevates self-sufficiency to a national goal and sets the deadline of the end of year 1, so the policy direction is unambiguous. Companies should not treat the current blocking as a short-term phenomenon; long-term market planning needs to take localisation into account from the beginning rather than as a later correction. The blocking test is therefore not a supplementary research task; it is the go/no-go instrument that determines whether the import pathway is viable for the product at all.

4. Practical recommendations

• Run a domestic-equivalent comparison before project initiation: produce the comparison report first, and only then decide whether to invest in registration at all, so that resources are not committed to a blocked route.
• Anchor the differentiation argument in parameters: prepare a technical parameter comparison table and use quantifiable indicators rather than descriptive differences.
• Treat local cooperative production as the second option: produce jointly with an Iranian local enterprise, simultaneously satisfying the 51% localization requirement.
• Allow ample time for exemption applications: where import is genuinely necessary, prepare the two-tier procedure of highest responsible person approval plus Ministry of Industry, Mine and Trade consent, whose cycle is long.

5. Verification checklist

• □ The comparison against Iranian-made equivalent products has been completed and a report issued
• □ The differentiation argument has been anchored in a quantified technical parameter comparison table
• □ The project schedule includes all four links: registration, import registration, foreign exchange and customs clearance
• □ The local cooperative production option has been evaluated, including a 51% localization cost calculation
• □ The two-tier exemption procedure and its cycle have been incorporated into the project plan

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 registration applications, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com