Health Sciences Authority
HSA · Singapore · asia pacific
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Singapore
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.hsa.gov.sg
Relevant Regulation Codes
- Health Products Act 2007 (Cap. 122D)
- Health Products (Medical Devices) Regulations 2010
- Traditional Chinese Medicine Practitioners Act 2000
Prescriber Requirements
- Singapore Medical Council–registered MD or TCM Practitioners Board–registered TCM Practitioner
- Allied health applies under physician order in hospitals (e.g., Singapore General Hospital plastic-surgery service)
- TCM scope explicitly includes leech therapy under TCM Board guidance
Supply Chain & GMP
Class B / Class C medical-device registration under HSA — depending on intended use. GDPMDS-compliant distributor. English-language labelling.
Import/Export Rules
HSA Import Licence + Agri-Food and Veterinary Authority (AVA, now Singapore Food Agency) clearance for live invertebrates. CITES Appendix II permits.
Reimbursement Context
MediShield Life and MediSave cover inpatient procedures under standard DRG. TCM-delivered leech therapy is private-pay; some Medisave-approved chronic-disease management programmes touch peripherally.
Key Regulatory Documents
ASH Editorial Notes
Singapore's parallel-track regulation (HSA for biomedical, TCM Board for traditional medicine) is among the world's most coherent dual-stream frameworks; leech therapy operates in both lanes.
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.