Iran is a large and important market in the Middle East with substantial demand for pharmaceuticals, medical devices, and health products, supported by a strong domestic industry and import needs.
The Iranian Food and Drug Organization (IFDO – سازمان غذا و دارو), under the Ministry of Health and Medical Education (MoHME), is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, cosmetics, and food supplements in Iran. IFDO requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Persian labelling, and local agent representation. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Iran’s requirements, prepare compliant dossiers, secure IFDO approvals and import authorizations, and achieve successful market entry and compliance in this significant regional market.
Get Iran Compliance Support
Preparation of regulatory dossiers, supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for IFDO submissions.
End-to-end support for IFDO registration of medicines, medical devices, cosmetics, and health products in Iran.
Assistance with IFDO import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for IFDO quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to IFDO, periodic safety reporting, and risk management in Iran.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with IFDO post-registration requirements.
Persian/Farsi labelling review, IFDO-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, IFDO liaison, regulatory follow-up, and ongoing compliance management in Iran.
Strategic market entry planning, IFDO pathway guidance, regulatory intelligence on Iran’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Iran — from IFDO product registration and import permits to pharmacovigilance, Persian labelling, and sustained market access.
Contact Our Iran Regulatory Experts