Maldives Food and Drug Authority — Republic of Maldives
Maldives FDA · Maldives · asia pacific
Maldives' national food / drug authority — leech-specific authorisation pathway not independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Maldives
- Leech status
- unregulated
- Last ASH review
- 2026-05-28
- Website
- https://www.mfda.gov.mv
Relevant Regulation Codes
- Maldives Drug Act 4/2011 and amendments
- Maldives Health Services Act 2015 and amendments
Prescriber Requirements
- Maldives Medical Council–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Maldives MFDA registration as applicable; Dhivehi and English-language labelling. Standard cold-chain conditions, with logistical constraints typical of Indian Ocean atoll-archipelago distribution.
Import/Export Rules
Maldives MFDA and Ministry of Fisheries, Marine Resources and Agriculture biosecurity clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Maldives Aasandha (universal health insurance) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific authorisation pathway not independently verified by ASH; falls under general medical-device / traditional-medicine framework as appropriate.
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.