Ministry of Health — Sultanate of Oman (Directorate General of Pharmaceutical Affairs and Drug Control)
Oman MoH-DGPADC · Oman · middle east
Oman's Ministry of Health, Directorate General of Pharmaceutical Affairs and Drug Control — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- middle east
- Country
- Oman
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.moh.gov.om
Relevant Regulation Codes
- Omani Law on Practice of the Pharmacy Profession and Establishments (Royal Decree No. 35/2015)
- Omani Ministry of Health Medical Devices Regulations
- GCC harmonised Drug Registration Procedures (where applicable)
Prescriber Requirements
- Oman Medical Specialty Board–credentialed physician (licensed by the Ministry of Health) — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Ministry of Health registration as applicable; Arabic and English-language labelling. Standard cold-chain conditions.
Import/Export Rules
Ministry of Health and Ministry of Agriculture, Fisheries and Water Resources clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Public health system coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. GCC member states share elements of pharmaceutical regulatory harmonisation; whether this captures live-organism medical devices has not been independently mapped by ASH.
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.