Ministry of Food and Drug Safety
MFDS · South Korea · asia pacific
South Korea's drug-safety regulator (formerly KFDA) — leech therapy practised within the Korean Medicine (한의학 / Hanui) tradition; Hirudo medicinalis listed in the Korean Pharmacopoeia.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- South Korea
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://www.mfds.go.kr/eng
Relevant Regulation Codes
- Pharmaceutical Affairs Act (약사법)
- Medical Service Act (의료법) — defines parallel MD / KMD scope
- Korean Pharmacopoeia, 11th ed., monograph 거머리 (geo-meo-ri)
Prescriber Requirements
- Korean Medicine Doctor (KMD / 한의사) is the principal prescriber within Hanui system
- Biomedical physician (MD / 의사) can also prescribe; dual licensing rare
- Allied health (nurses) under physician's order in hospital settings
Supply Chain & GMP
KMD pharmacies (한약방) traditionally stock dried leech preparations; live-leech supply chain is limited to specialised tertiary hospitals (Seoul National University Hospital, Asan Medical Centre).
Import/Export Rules
Imports require MFDS permission and Animal and Plant Quarantine Agency (APQA) clearance. CITES paperwork for Hirudo spp.
Reimbursement Context
National Health Insurance Service (NHIS / 국민건강보험공단) covers Hanui treatments selectively — hirudotherapy reimbursement depends on diagnostic code and provider type; reconstructive-surgery indications generally covered when delivered by MD.
Key Regulatory Documents
ASH Editorial Notes
MFDS was renamed from KFDA in 2013; both terms appear in older literature. Korea operates parallel biomedical (MD) and Korean Medicine (KMD) systems — both have leech-therapy scope.
Related Jurisdictions
PMDA — Japan
Japan's medicines and devices regulator — leech therapy classified within the Kampo / traditional-medicine framework under MHLW oversight, with no PMDA-issued device approval to date.
NMPA — China
China's medical-products regulator — leeches (水蛭 / shui zhi) are codified in the Chinese Pharmacopoeia as Traditional Chinese Medicine (TCM) and regulated as a Chinese herbal medicine.
CDSCO — India
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.
HSA — Singapore
Singapore's health sciences regulator — leech therapy supervised under the Health Products Act 2007 with separate licensing for TCM practitioners using leeches in clinical practice.