Reference-Country Approvals in Iranian Medical Device Registration

1. Key takeaways

Iran has not, in its public texts, made CE or FDA approval a formal statutory precondition for registration. Market reality, however, is different: the overwhelming majority of international brands that have entered Iran already hold CE or FDA approval. The judgment of GRZAN is that reference-country approval in Iran is strong evidence rather than a hard threshold — it cannot substitute for Iranian local registration, but it can significantly change both the review pathway and the commercial negotiating position. More importantly, clause B of Article 72 of the Seventh National Development Plan is pushing this de facto reference toward institutionalised mutual recognition, which means the weight of these approvals is set to increase rather than fade.

• CE and FDA approvals function in Iran as the strongest available technical credibility endorsement, not as a legal gate.
• Reference-country evidence changes the review pathway because it supports the argument that the product is routine rather than novel.
• Clause B of Article 72 requires the Ministry of Health and Medical Education, by the end of plan year 2, to pursue bilateral and multilateral negotiations so that other states accept Iranian-issued registration certificates, market access permits and joint production quality certificates.
• Clause A of the same article sets annual export targets of more than 1 billion euros for both medical devices and drugs, signalling the export dimension of the policy.
• Iran accepts declarations of conformity based on its own classification, the EU classification or the US FDA classification, as recorded in the WHO overview of medical device nomenclature systems.
• Companies without reference-country approval can substitute a structured evidence combination, provided the logic is explained in writing inside the dossier.
• The closer the submitted documentation is to international structures, the higher the future benefit from mutual recognition arrangements.

2. Legal basis

The core provision is clause B of Article 72 of Chapter 14 of the Seventh National Development Plan Law of the Islamic Republic of Iran, in force for Iranian years 1403–1407 (2024–2028). It requires the Ministry of Health and Medical Education, no later than the end of plan year 2, through bilateral and multilateral negotiations that prioritise regional countries, countries of the civilisational sphere and members of the Eurasian Economic Union, to push those states to accept Iranian-registered active pharmaceutical ingredients, drugs, consumables and medical devices, and to issue registration certificates, market access permits and joint production quality certificates. The clause thus operates in two directions at once: outward, toward acceptance of Iranian outcomes by other states, and inward, toward convergence of the Iranian system with comparable international practice.

Clause A of the same Article 72 sets the export dimension of the policy: the annual export value targets for medical devices and for drugs are both set at more than 1 billion euros. This places the mutual recognition agenda inside an explicit export strategy rather than a purely technical harmonisation exercise.

On classification, Iran accepts declarations of conformity based on its own national classification, the EU classification or the US FDA classification. This is recorded in the entry for Iran in the World Health Organization overview of medical device nomenclature systems in WHO Member States, which supports the argument that reference-country frameworks are legible to the Iranian reviewer.

3. Expert insights

Insight 1: distinguishing regulatory requirement from market practice is decisive for corporate strategy. A company that mistakes CE for a hard threshold may abandon Iran outright when it holds no CE mark; a company that treats CE as irrelevant may lose the single most powerful piece of triage evidence during review. The correct positioning is that CE/FDA approval is the strongest technical credibility endorsement available, and it should be deployed wherever it strengthens the pathway argument and the commercial position at the same time.

Insight 2: clause B of Article 72 aims at exporting mutual recognition, but the reverse value also exists. The clause requires other states to accept Iranian registration outcomes, and its implied premise is that Iran’s own registration system must converge toward internationally comparable standards. The closer the documentation a company submits in Iran is to the internationally standard structure — STED format, ISO quality systems, GHTF classification — the higher the probability that it will benefit from future mutual recognition arrangements, and the same submissions therefore serve the Iranian case and the regional strategy simultaneously.

Insight 3: companies without reference-country approval have an alternative evidence path. A combination of complete ISO 13485 quality system evidence, ISIRI or international standard test reports and documented marketing history can substitute for reference-country approval. What matters is that the logic of the evidence combination is explained proactively in the dossier, so that the reviewer reads it as a coherent substitution argument rather than as missing material.

4. Practical recommendations

• With CE/FDA in hand, place it at the front of the dossier: use it as pathway argumentation and credibility evidence, not as appendix material, so that the reviewer meets it before forming any doubt.
• Without CE/FDA, prepare an evidence combination explanation: compose the combination from the quality system certificate, test reports and marketing history, and explain the substitution logic in writing.
• Organise documentation according to the international standard structure: adopt the STED format and GHTF classification, leaving an interface for future mutual recognition.
• Track the progress of clause B of Article 72 negotiations: follow the outcomes of negotiations with the Eurasian Economic Union and regional countries, and assess the spillover opportunities they create for products already registered in Iran.

5. Verification checklist

• □ Reference-country approval status has been confirmed and its position in the dossier decided
• □ Where reference-country approval is absent, an alternative evidence combination and written explanation have been prepared
• □ The dossier structure follows the internationally accepted practice of STED and GHTF classification
• □ A tracking mechanism for clause B of Article 72 negotiation progress has been established
• □ The potential spillover value of the Iranian registration for neighboring markets has been assessed

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