Кыргыз Республикасынын Саламаттык сактоо министрлигине караштуу Дары-дармек жана медициналык буюмдар департаменти
Kyrgyzstan DMS · Kyrgyzstan · asia pacific
Kyrgyzstan's Department of Medicines and Medical Devices (Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Kyrgyzstan
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.pharm.kg
Relevant Regulation Codes
- Kyrgyz Law on Medicines (Law No. 91, 2003, as amended)
- Kyrgyz national medical device regulatory framework
- Eurasian Economic Union (EAEU) harmonised pharmaceutical frameworks where applicable
Prescriber Requirements
- Kyrgyz medical chamber–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Kyrgyzstan DMS registration as applicable; Kyrgyz and Russian-language labelling per local convention. Standard cold-chain conditions.
Import/Export Rules
Kyrgyzstan DMS and State Inspectorate for Veterinary and Phytosanitary Security clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Kyrgyz Mandatory Health Insurance Fund (MHIF) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Central Asian regulatory frameworks are progressively coordinating through the Eurasian Economic Union (EAEU); whether this captures live-organism medical 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.