National Centre for Expertise of Medicines and Medical Devices
NCEPM · Kazakhstan · asia pacific
Kazakhstan's National Centre for Expertise of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Kazakhstan
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.ndda.kz
Relevant Regulation Codes
- Kazakhstani national medicines and medical-device law
- Eurasian Economic Union (EAEU) medical-device harmonisation rules as applicable
Prescriber Requirements
- Kazakhstani-licensed physician (дәрігер) under Ministry of Health authority — order required for any biomedical device application
- Traditional medicine practitioner scope under Kazakhstani national law not independently verified by ASH
Supply Chain & GMP
NCEPM registration as applicable; Kazakh and Russian-language labelling. Standard cold-chain conditions.
Import/Export Rules
Import licence requirements; EAEU intra-union movement rules may apply; veterinary 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. Kazakhstan participates in EAEU regulatory harmonisation alongside Russia, Belarus, Armenia, and Kyrgyzstan; the practical interaction between EAEU and national-level NCEPM review for live-organism devices has not been independently mapped by ASH.
Related Jurisdictions
Roszdravnadzor — Russia
Russia's federal healthcare regulator — uniquely classifies medicinal leeches as a pharmaceutical drug under Federal Law No. 61-FZ, with a federally recognised hirudotherapy speciality and OMS coverage.
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.