Thai Food and Drug Administration
Thai FDA · Thailand · asia pacific
Thailand's FDA under the Ministry of Public Health — leech-specific regulatory status has not been independently verified by ASH; Thai traditional medicine has separate statutory framework under the DTAM.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Thailand
- Leech status
- unregulated
- Last ASH review
- 2026-05-25
- Website
- https://www.fda.moph.go.th
Relevant Regulation Codes
- Medical Device Act B.E. 2551 (2008) and amendments
Prescriber Requirements
- Thai Medical Council-licensed physician for biomedical use
- Department for Development of Thai Traditional and Alternative Medicine (DTAM)-registered practitioners may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
Thai FDA medical-device registration if classified as a device; Thai-language labelling.
Import/Export Rules
Thai FDA import licence plus Department of Livestock Development veterinary clearance for live invertebrates; CITES Appendix II paperwork.
Reimbursement Context
Universal Coverage Scheme (UCS), Civil Servant Medical Benefit Scheme (CSMBS), and Social Security Scheme (SSS) coverage for hirudotherapy not independently verified by ASH.
ASH Editorial Notes
Specific Thai regulatory pathway for medicinal leech use has not been independently verified by ASH. Thailand has a robust statutory framework for Thai traditional medicine via the DTAM; whether leech therapy falls under that framework or under the FDA medical-device pathway is jurisdictionally uncertain and should be confirmed with Thai counsel.
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.
MFDS — South Korea
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.
CDSCO — India
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.