Pharmaceuticals and Medical Devices Agency
PMDA · Japan · asia pacific
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Japan
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://www.pmda.go.jp
Relevant Regulation Codes
- Pharmaceuticals and Medical Devices Act (PMD Act / 薬機法), Law No. 145 of 1960 as amended
- Medical Practitioners' Act (医師法)
- Kampo / traditional Japanese medicine framework under MHLW Notification No. 65 (2008)
Prescriber Requirements
- Ishi (licensed physician under MHLW) is the only licensed prescriber
- Acupuncturists (hari-shi) and moxibustionists (kyu-shi) have separate licensure but not for leech application
- Kampo specialisation is a board credential under Japan Society for Oriental Medicine; not federally required
Supply Chain & GMP
Importation requires MHLW notification under PMD Act Art. 14, but as leech therapy lacks formal device classification it operates in a regulatory grey zone — most clinical use is via individual physician import authorisations.
Import/Export Rules
Live invertebrate import via MHLW + Ministry of Agriculture, Forestry and Fisheries (MAFF) Plant Protection Station. CITES Appendix II compliance required.
Reimbursement Context
Japanese National Health Insurance (NHI / 健康保険) does not cover hirudotherapy — treatments are private-pay (自由診療 / jiyu-shinryo).
Key Regulatory Documents
ASH Editorial Notes
Hirudotherapy adoption in Japan is minimal compared to other Asia-Pacific markets; published clinical use is essentially confined to plastic-surgery flap-salvage at major academic centres (Keio, Tokyo University).
Related Jurisdictions
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.
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.