National Pharmaceutical Regulatory Agency
NPRA · Malaysia · asia pacific
Malaysia's National Pharmaceutical Regulatory Agency (under the Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general medical device framework or traditional and complementary medicine pathways as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Malaysia
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.npra.gov.my
Relevant Regulation Codes
- Malaysian national medical device law (Medical Device Act and subsidiary regulations)
- Malaysian Traditional and Complementary Medicine Act framework
Prescriber Requirements
- Malaysian Medical Council–registered physician — order required for any biomedical device application
- Traditional and complementary medicine practitioners registered under the Malaysian framework may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
Malaysian medical-device establishment registration as applicable; Bahasa Malaysia and English-language labelling. Standard cold-chain conditions.
Import/Export Rules
Import licence requirements under Malaysian medical-device law; Department of Veterinary Services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Malaysia has a parallel Traditional and Complementary Medicine Division within the Ministry of Health; whether leech therapy is regulated under T&CM or as a medical device has not been independently verified.
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.