Iran Food and Drug Administration
Iran FDA · Iran · middle east
Iran's Food and Drug Administration (under the Ministry of Health and Medical Education) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under traditional Persian medicine (Tibb-e-Sonnati) pathways alongside the contemporary biomedical framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- middle east
- Country
- Iran
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.fda.gov.ir
Relevant Regulation Codes
- Iranian Food, Drug, Cosmetics and Medical Devices Act
- Iranian framework for traditional Persian medicine (Tibb-e-Sonnati) — overseen by the Office of Iranian Traditional Medicine, Ministry of Health and Medical Education
Prescriber Requirements
- Iranian Medical Council–registered physician — order required for any biomedical device application
- Traditional Persian medicine practitioners with relevant Ministry of Health credentialing may have separate scope, including hirudotherapy (zaloo-darmani); specific contemporary authorisation has not been independently verified by ASH
Supply Chain & GMP
Iran FDA registration as applicable; Persian (Farsi) and English-language labelling. Standard cold-chain conditions; sanctions environment may complicate cross-border supply.
Import/Export Rules
Iran FDA and Ministry of Health import authorisation; Iran Veterinary Organisation clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana. International sanctions may further restrict commercial flows.
Reimbursement Context
Iran Health Insurance Organisation and complementary public payers may cover inpatient bundled use; outpatient hirudotherapy under traditional Persian medicine is variably reimbursed depending on provider credentialing.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; traditional Persian medicine has historical recognition of hirudotherapy as zaloo-darmani, and the Office of Iranian Traditional Medicine within the Ministry of Health and Medical Education provides a formal national framework. The precise interface between Iran FDA biomedical regulation and traditional medicine oversight has not been independently mapped by ASH. Sanctions-related risk should be evaluated with counsel.
Related Jurisdictions
Israeli MoH — Israel
Israel's Ministry of Health (Misrad HaBri'ut) — leech therapy regulated under the Pharmacists' Ordinance with Medical Devices Division oversight; significant clinical use in reconstructive and microsurgery services.
EDA — Egypt
Egypt's Egyptian Drug Authority (formed 2019, replacing the older CAPA / Central Administration of Pharmaceutical Affairs) — leech therapy regulated as a medical device with parallel traditional-medicine context.
SFDA — Saudi Arabia
Saudi Arabia's SFDA — leech therapy supervised under medical-device pathway, with Saudi Vision 2030 expansion of traditional/complementary medicine via NCCAM-KSA at the Ministry of Health.
MOHAP — United Arab Emirates
UAE Ministry of Health and Prevention — federal authority over health products; leech-specific regulation has not been independently verified by ASH.