Philippine Food and Drug Administration
DOH-FDA · Philippines · asia pacific
Philippine FDA (under Department of Health) — leech therapy regulated as a medical device with parallel traditional and alternative medicine pathway under the PITAHC framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Philippines
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.fda.gov.ph
Relevant Regulation Codes
- Republic Act No. 9711 — Food and Drug Administration Act of 2009
- Republic Act No. 8423 — Traditional and Alternative Medicine Act (TAMA) of 1997
- FDA Circular No. 2014-005 (medical-device classification rules)
Prescriber Requirements
- Professional Regulation Commission (PRC) Board of Medicine–licensed MD
- PITAHC-accredited traditional medicine practitioners under TAMA scope
- RN application under physician supervision per Board of Nursing scope
Supply Chain & GMP
FDA Philippines License to Operate (LTO) + Certificate of Product Registration (CPR) for the device. English-language IFU.
Import/Export Rules
FDA-issued import permit + Bureau of Animal Industry (BAI) clearance for live invertebrates. CITES paperwork via Department of Environment and Natural Resources (DENR).
Reimbursement Context
PhilHealth has no dedicated case-rate for leech therapy; inpatient flap salvage absorbed into the relevant case-rate package (e.g., RVS code for flap repair). Private payment prevails outside hospital settings.
Key Regulatory Documents
ASH Editorial Notes
PITAHC (Philippine Institute of Traditional and Alternative Health Care) is a unique statutory body responsible for accrediting and integrating non-biomedical practices, including hirudotherapy, into the national healthcare system.
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.