မြန်မာနိုင်ငံ အစားအသောက်နှင့် ဆေးဝါးကွပ်ကဲရေး ဦးစီးဌာန
Myanmar FDA · Myanmar · asia pacific
Myanmar's Food and Drug Administration (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
- Myanmar
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.fda.gov.mm
Relevant Regulation Codes
- Myanmar National Drug Law (1992, as amended)
- Myanmar national medical device regulatory framework
- ASEAN Medical Device Directive (AMDD) harmonised frameworks where applicable
Prescriber Requirements
- Myanmar Medical Council–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Myanmar FDA registration as applicable; Burmese and English-language labelling. Standard cold-chain conditions.
Import/Export Rules
Myanmar FDA and Livestock Breeding and Veterinary Department clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Myanmar's public health system coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed. Governance and operational stability of the Myanmar pharmaceutical regulatory system has been affected by the post-2021 political situation, which may affect verification.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. The Myanmar pharmaceutical regulatory framework's contemporary operational status is affected by the post-2021 political situation, which adds uncertainty to verification; whether the framework captures live-organism medical devices has not been independently mapped by ASH.
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.