Iran Medical Device Regulatory System Overview: MOHME, IFDA and IMED

1. Key takeaways

Iran’s medical device regulatory chain is organised on three levels: the Ministry of Health and Medical Education (MOHME) is the statutory supervising ministry, the Iran Food and Drug Administration (IFDA) is the executive agency, and the General Directorate of Medical Equipment and Supplies (IMED) is the operational unit that actually conducts device review and coding. GRZAN’s assessment is that the only layer a company genuinely deals with is IMED, yet every legal consequence traces back to the authorisation chain of MOHME, and for this reason the expression of the “approving authority” on any document must never be written incorrectly. It is equally important to understand what an approval actually produces in Iran. Once a product is approved, it obtains an Iran Registration Code (IRC), not a “registration certificate” in the traditional sense. The IRC is a one-product-one-code identification scheme, whereas a certificate is a document of title; the two carry different legal functions, and conflating them in correspondence, contracts or customs paperwork creates avoidable confusion. In practical terms, a manufacturer preparing an Iranian submission should map every document it produces to the correct layer of the chain: technical files and portal operations point to IMED, while any statement about legal authority points to MOHME and IFDA. Companies that internalise this three-layer logic early tend to move through the Iranian process with fewer corrections, fewer resubmissions and materially less friction with the reviewing authorities.

2. Legal basis

1. The Law Concerning the Regulations on Medical, Pharmaceutical and Food and Beverage Affairs (FAOLEX number LEX-FAOC227692), published on 20 June 1955: Article 1 (the establishment and operation of medical institutions, pharmacies, laboratories and similar facilities requires a licence from the Ministry of Health) and Article 3 (the import, manufacture and sale of sera, vaccines, infant foods, prepared medicines and comparable products requires the prior approval of the Ministry of Health). Read together, these two provisions establish both the facility licensing logic and the product pre-approval logic on which Iran’s later device import control was built.
2. The Seventh National Development Plan Law of the Islamic Republic of Iran (in force for Iranian calendar years 1403–1407, corresponding to 2024–2028 Gregorian): Chapter 14 on “Health System Improvement”, Article 72, paragraph A, which sets self-sufficiency and export targets for medical equipment and supplies. By placing device manufacturing and export capability among explicit national planning objectives, this provision shapes how the authorities weigh the sector in day-to-day decisions.
3. Submission gateway: the IMED portal imed.ir carries the online processing of company, product and import procedures, and Class A and Class B manufacturing licence applications have been made fully electronic from end to end. This statement is drawn from the public page of the Food and Drug Deputy of Iran University of Medical Sciences; no official document number has been identified, so this is a practical estimate.

3. Expert insights

First, the 1955 law remains the source of authority to this day. Many companies assume that Iran has a dedicated “medical device law”; in reality, Iran’s authority to regulate devices derives from a law on medical, pharmaceutical and food and beverage affairs enacted in 1955, which has been elaborated layer by layer through subsequent implementing regulations, ministerial directives and committee standards. One direct consequence follows from this structure: the hierarchy of these instruments is not clearly ranked, so the same matter may be addressed by several instruments carrying different formulations. Companies must therefore defer to the accepting authority’s position in the current case rather than to any second-hand source, however authoritative that source may appear. Building a file that quotes the exact wording used by the reviewer in the current cycle is far more effective than arguing from generic summaries of Iranian law found in international databases.

Second, the IRC is an identifier, not a certificate. The core instrument Iran applies to medical devices is the Iran Registration Code, granted on the combination of “product plus manufacturer”. This means that two models from the same company will each receive their own IRC, so model management becomes a continuous compliance activity rather than a one-time action. Every new model introduced to the Iranian market opens a new regulatory file, with its own coding, its own review and its own ongoing maintenance obligations, and this should be reflected in project planning and budgets from the outset.

Third, the Seventh National Development Plan Law is changing the outward-facing character of the system. Article 72, paragraph A makes device self-sufficiency and exports a national objective, while paragraph B calls for regional states to accept Iranian registration outcomes. GRZAN’s assessment on this basis is that Iran’s registration system is shifting from “inward-facing market access” toward a “two-way” orientation, and a company’s valuation model when planning for Iran should include regional spillover value. Registration in Iran may therefore carry benefits beyond the domestic market, and documents prepared to a regionally recognisable standard can capture that value at little additional cost.

4. Practical recommendations

1. Fix the entity first, then the timeline: before any technical documentation work begins, lock in the Iranian local importer or authorised representative, because the submission account, the ownership of the IRC and all subsequent responsibilities attach to that entity.
2. Maintain an IRC ledger on the “product plus manufacturer” basis: manage every model as an independent compliance unit and never rely on one registration to cover several models, since each model requires its own code and its own file.
3. Distinguish the “approving authority” from the “executing body”: in external documents and contracts, the competent authority should be written as MOHME/IFDA, while day-to-day communication and system operations point to IMED.
4. Assess regional spillover in parallel: if the product is also destined for the Eurasian Economic Union or neighbouring markets, organise the dossier against mutually recognisable standards at the time of the Iranian submission, so the same material can serve more than one market.

5. Verification checklist

• □ The three-level names and hierarchy of the regulatory chain have been confirmed, and entity wording in contracts and letters of authorisation is correct
• □ The Iranian local importer or authorised representative has been selected, and its legal registration status in Iran has been verified
• □ A model ledger has been built on the “product plus manufacturer” basis, and the number of IRCs to be applied for is clear
• □ Company-side account registration on imed.ir has been completed (handled by the local entity)
• □ It has been verified whether an Iranian-made equivalent exists for the products to be submitted, since this affects whether import registration can proceed

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