Department of Health and Social Affairs — Federated States of Micronesia
FSM DHSA · Micronesia (Federated States) · oceania
Federated States of Micronesia DHSA — leech-specific authorisation pathway not independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- oceania
- Country
- Micronesia (Federated States)
- Leech status
- unregulated
- Last ASH review
- 2026-05-28
- Website
- https://gov.fm
Relevant Regulation Codes
- FSM Pharmaceutical Practice Act and amendments
- Compact of Free Association arrangements with the United States as applicable
- Pacific Island Countries (PIC) joint procurement arrangements through the Pacific Pharmaceutical Procurement Service where applicable
Prescriber Requirements
- FSM DHSA–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
FSM DHSA registration as applicable; English-language labelling (with state-level vernaculars per local convention). Standard cold-chain conditions, with logistical constraints typical of multi-state Micronesian distribution.
Import/Export Rules
FSM DHSA and Quarantine Division clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
FSM's national health insurance scheme coverage depends on inpatient bundling. Compact-of-Free-Association arrangements with the US may apply.
ASH Editorial Notes
Leech-specific authorisation pathway not independently verified by ASH; falls under general medical-device / traditional-medicine framework as appropriate. FSM Compact of Free Association with the United States introduces complex jurisdictional questions for medical-device classification that ASH has not independently mapped.
Related Jurisdictions
FDA — United States
First regulator in the world to clear medicinal leeches as a medical device — Hirudo medicinalis cleared under K040187 (June 21 2004).
TGA — Australia
Australia's therapeutic-goods regulator — medicinal leeches included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa medical device with import permit oversight.
Medsafe — New Zealand
New Zealand's medicines and medical-devices regulator — operates under the Medicines Act 1981 with leech therapy regulated as a notified medical device and biosecurity-controlled import.
Fiji PTS — Fiji
Fiji's Pharmacy and Therapeutics Section (under the Ministry of Health and Medical Services) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.