Mongolian Ministry of Health — Medicines Regulatory Authority
Mongolia MRA · Mongolia · asia pacific
Mongolia's Medicines Regulatory Authority (under the Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under traditional Mongolian medicine alongside the contemporary biomedical framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Mongolia
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.mohs.mn
Relevant Regulation Codes
- Mongolian Law on Medicines and Medical Devices (2010, as amended)
- Mongolian Law on Traditional Medicine
- Mongolian national medical device regulatory framework
Prescriber Requirements
- Mongolian Medical Council–licensed physician — order required for any biomedical device application
- Traditional Mongolian medicine practitioners with relevant Ministry of Health credentialing may have separate scope; specific contemporary hirudotherapy authorisation has not been independently verified by ASH
Supply Chain & GMP
Ministry of Health registration as applicable; Mongolian-language (Cyrillic script) labelling. Standard cold-chain conditions, with logistical constraints typical of continental Central Asian distribution.
Import/Export Rules
Ministry of Health and General Authority for Veterinary Services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Health Insurance General Office coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Mongolia has a national framework for traditional medicine that overlaps with biomedical regulation. The interface between these frameworks for live-organism therapeutic agents 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.