Drug Administration of Vietnam / Department of Medical Equipment and Health Works
DAV / MOH-MD · Vietnam · asia pacific
Vietnam's Ministry of Health medical-device and pharmaceutical authorities — leech-specific regulation has not been independently verified by ASH and may fall under traditional-medicine carve-outs.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Vietnam
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://dav.gov.vn
Relevant Regulation Codes
- Pharmacy Law of Vietnam (Law No. 105/2016/QH13)
- Decree on management of medical devices (Vietnamese national medical-device framework)
Prescriber Requirements
- Vietnamese-licensed physician (bác sĩ) prescription required
- Traditional medicine practitioners (y học cổ truyền) registered under the Ministry of Health may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
Vietnamese national medical-device registration via the Ministry of Health Department of Medical Equipment and Health Works; Vietnamese-language labelling.
Import/Export Rules
Ministry of Health import licence; Department of Animal Health veterinary clearance for live invertebrates; standard CITES Appendix II paperwork for Hirudo medicinalis.
Reimbursement Context
Vietnam Social Security health insurance (BHYT) coverage for traditional medicine modalities including hirudotherapy not independently verified by ASH.
ASH Editorial Notes
Vietnam has a strong traditional medicine tradition (y học cổ truyền) institutionalised in parallel with biomedicine via the Vietnam National Hospital of Traditional Medicine. Specific leech regulatory pathway has not been independently verified by ASH; the status "traditional-medicine" reflects the likely framework but should be confirmed with Vietnamese 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.