National Health Regulatory Authority — Kingdom of Bahrain
Bahrain NHRA · Bahrain · middle east
Bahrain's National Health Regulatory Authority — 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
- Bahrain
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.nhra.bh
Relevant Regulation Codes
- Bahraini Decree-Law No. 18 of 1997 on the Practice of the Pharmacy Profession and Pharmaceutical Establishments, as amended
- Bahraini NHRA Resolutions on Medical Devices
- GCC harmonised Drug Registration Procedures (where applicable)
Prescriber Requirements
- NHRA-licensed physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
NHRA registration as applicable; Arabic and English-language labelling. Standard cold-chain conditions.
Import/Export Rules
NHRA and Ministry of Works, Municipalities Affairs and Urban Planning clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Bahraini 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.