Taiwan Food and Drug Administration
TFDA · Taiwan · asia pacific
Taiwan's food and drug administration — leech preparations regulated under the Pharmaceutical Affairs Act with traditional Chinese medicine practice formally licensed under the Ministry of Health and Welfare.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Taiwan
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://www.fda.gov.tw/eng
Relevant Regulation Codes
- Pharmaceutical Affairs Act (藥事法)
- Medical Devices Act (醫療器材管理法), 2020
- Regulations on Pharmaceutical Affairs of Chinese Herbs (中藥業務管理辦法)
Prescriber Requirements
- Western-medicine physician (MD) or Chinese-medicine physician (中醫師) — parallel licensure
- Chinese-medicine physicians trained in leech application as part of formal TCM curriculum
- Nurses apply under physician's order
Supply Chain & GMP
Medical Devices Act 2020 introduced formal device registration; dried leech preparations regulated as Chinese herbal pharmaceuticals.
Import/Export Rules
TFDA import licence + Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ) clearance for live invertebrates. CITES paperwork as elsewhere.
Reimbursement Context
National Health Insurance (健保 / Jianbao) covers traditional Chinese medicine including selected leech-based formulations; live-leech procedural reimbursement variable.
Key Regulatory Documents
ASH Editorial Notes
The Medical Devices Act 2020 created a separate regulatory pathway distinct from the Pharmaceutical Affairs Act, modernising Taiwan's framework. Leech preparations span both depending on intended use.
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.